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[text] => The Food and Drug Administration (FDA) added a black box warning to Invokana, a new-age drug used to treat diabetes. The black box warning, which is the agency's highest-level alert, was released in a safety communication on May 16.
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[text] => The warning comes after the CANVAS and CANVAS-R studies confirmed a significant increase in risk of leg and foot amputations for patients taking Invokana. Results showed that Invokana users were twice as likely to require an amputation compared to patients who took a placebo.
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[text] => On Dec. 7, 2016, the U.S. Judicial Panel on Multidistrict Litigation ordered the cases be joined into a multidistrict legislation (MDL). The transfer order also includes lawsuits regarding Invokamet, another version of the type II diabetes drug.
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[text] => Manufactured by the Johnson & Johnson subsidiary, Janssen Pharmaceuticals, Invokana and Invokamet are used to treat type II diabetes. The medications, approved by the Food and Drug Administration (FDA) in 2013, contain the active ingredient canagliflozin.
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[text] => The drugs are classified as sodium glucose cotransporter 2 (SGLT2) inhibitors, which maintain glucose levels by depositing excess blood sugar through the urine. Because SGLT2 inhibitors work closely with the kidneys, it could lead to a condition known as ketoacidosis.
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[text] => Ketoacidosis is caused by excess amounts of acid in the bloodstream. These toxins cause a number of serious symptoms, including abdominal pain, frequent urination, mental confusion, and shortness of breath. Left untreated, ketoacidosis may result in a medical emergency.
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[text] => Judge Brian R. Martinotti will preside over Invokana and Invokamet lawsuits. For more than a decade, Judge Martinotti worked in the Superior Court of New Jersey on multidistrict litigations to expedite mass tort cases. The lawsuits were previously filed in various states, including Illinois, Kentucky, Missouri, Minnesota, Virginia and West Virginia.
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[text] => An MDL combines multiple suits from different states under one court. The court in New Jersey is also handling lawsuits filed against Johnson & Johnson’s Baby Powder, whose talcum component has been linked to ovarian cancer. Johnson & Johnson is headquartered in New Jersey.
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[text] => The MDL is intended to make Invokana and Invokamet lawsuits more efficient in the hopes of getting quicker resolutions. On Jan. 12, the parties held a conference to discuss the first case management order, focusing on discovery of evidence and future scheduling. The second case management conference takes place on Feb. 23, 2017.
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[text] => Results from the government-mandated CANVAS study show the diabetes drug Invokana can double the risk of lower limb amputations. The findings prompted the Food and Drug Administration (FDA) to add a black box warning to Invokana’s labeling on May 16.
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[text] => The increased risk of amputation has affected the intent to prescribe and treat diabetes patients with Invokana. According to MedPage Today, physicians and hospitals have started to discontinue use of the popular diabetes medication.
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[text] => After finding a disturbing number of severe nursing home abuse cases are not being reported, the Office of Inspector General at the Department of Health and Human Services issued an urgent alert. Federal law requires serious cases of abuse to be turned over to local police, but investigations show that authorities are not being informed—even when the abuse is so severe it could warrant an emergency room visit.
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[text] => A recent study, known as the COMPASS trial, showed the blood thinner Xarelto can reduce the risk of heart attack and stroke when combined with aspirin. The positive cardiovascular results, hailed as a victory for manufacturers, were showcased at the European Society of Cardiology 2017 Congress.
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[text] => A MedScape editorial reported small differences in risk reduction, as major bleeding with Xarelto doubled in patients older than 75 years. “Although major bleeding was higher with rivaroxaban/aspirin, fatal bleeding did not differ,” according to MedScape.
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[text] => Manufactured by Johnson & Johnson, the sodium-glucose cotransporter 2 (SGLT2) inhibitor falls into the category of new-age treatments. Doctors can prescribe the drug in 100mg or 300mg doses that are compressed in a once-daily tablet. The majority of Invokana users begin at the lowest level.
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[text] => Invokana is used for the treatment of type II diabetes, which occurs when the body cannot effectively use insulin. The medication’s active ingredient, canagliflozin, works with the kidneys to deposit excess glucose in urine, maintain safe blood sugar levels and keep patients from going into diabetic shock.
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[text] => Manufactured by Johnson & Johnson, the sodium-glucose cotransporter 2 (SGLT2) inhibitor falls into the category of new-age treatments. Doctors can prescribe the drug in 100mg or 300mg doses that are compressed in a once-daily tablet. The majority of Invokana users begin at the lowest level.
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[text] => A large portion of scientific research on diabetes drugs has been FDA-mandated and conducted by manufacturers, while other data comes from adverse event reports. Millions of Americans currently have or will develop diabetes, which elevates understanding the disease and treatment options to a high priority.
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[text] => Diabetes drugs are divided into various classes, with SGLT2 inhibitors and dipeptidyl peptidase 4 (DPP-4) inhibitors at the forefront. While both medications improve the function of insulin systems, each drug targets and blocks a different hormone.
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[text] => DPP-4 inhibitors prevent the DPP-4 enzyme from inactivating essential gut-balancing hormones, whereas SGLT2 inhibitors work with the kidneys to unload excess glucose in urine. SGLT2 is the human protein responsible for 90 percent of glucose reabsorption.
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[text] => SGLT2 inhibitors have three main functions:
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[text] => to block the reabsorption of glucose in the kidney
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[text] => to increase glucose excretion
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[text] => to lower blood glucose levels
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[text] => What is ketoacidosis?
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[text] => Ketoacidosis is a condition that can quietly sneak up on diabetics and quickly spin their diabetes out of control. Ketoacidosis is a medical emergency that can lead to a diabetic coma, require hospitalization and sometimes cause death.
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[text] => When the body isn’t receiving enough carbohydrates, it burns fat to store and use as fuel. Ketosis occurs when this process causes poisonous compounds called ketones to develop in the blood.
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[text] => Acidosis is increased acidity in the blood caused by the ketones, which occurs when the body doesn’t have enough insulin to use glucose as its primary energy source.
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[text] => Ketoacidosis has been linked to kidney problems, urinary tract infections, weight loss, vomiting, dehydration, confusion, fatigue, and abdominal pain. When the condition becomes serious, treatment is often administered in a hospital setting and may include intravenous fluids, insulin and glucose.
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[text] => Through the FDA Adverse Event Reporting System (FAERS) database, the agency pinpointed 73 cases of ketoacidosis caused by SGLT2 inhibitors. The agency only included cases reported from March 2013 to May 2015, asserting that “there are likely additional cases about which we are unaware.”
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[text] => Ketoacidosis is a common side effect associated with the diabetes drug Invokana, but it isn’t the only one. Additional Invokana side effects include bone fractures, cardiovascular complications, genital infections and amputations.
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[text] => Bone Fractures
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[text] => Data illustrates that Invokana can speed up the loss of bone density, resulting in osteoporosis. A government-mandated Johnson & Johnson study showed accelerated deterioration of spine and hip bones after two years of using the drug. The post-market safety study involved nine clinical trials and more than 700 geriatric patients who took Invokana for an average of 85 weeks.
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[text] => “The additional data confirm the finding that fractures occur more frequently with canagliflozin than placebo,” the study authors write. “Fractures can occur as early as 12 weeks after starting the drug. In the clinical trials, when trauma occurred prior to a fracture, it was usually minor, such as falling from no more than standing height.”
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[text] => While some patients didn’t notice the effects of Invokana for an extended period, few experienced bone fractures within three months of use. Issues with bone density were found to be most common in postmenopausal women, and generally occurred in the hips and lower spine.
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[text] => Kidney Injuries
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[text] => From March 29, 2013 to October 19, 2015, the FDA found 101 cases of acute kidney injury. The organization identified 73 injuries caused by Invokana. The FDA Adverse Event Reporting System (FAERS) database illustrated that 96 out of 101 people had to be hospitalized, with 22 requiring intensive care. Out of the four people who died, two experienced cardiac complications.
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[text] => Fifteen patients received dialysis, and of these, 3 patients had a history of chronic kidney disease or previous acute kidney injury. In 58 cases, the Invokana patient developed acute kidney injury occurred within one month or less. More than half of these individuals were 60 years or younger.
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[text] => In addition to the two deaths discovered in the FAERS reporting system, the manufacturer’s post-marketing clinical trials also uncovered a high hazard ratio for cardiac events. Some patients may experience a heart attack or stroke within the first 30 days of treatment.
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[text] => Urinary Tract and Yeast Infections
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[text] => The FDA used the FAERS database to detect 19 urinary tract infections, linked to the use of SGLT2 inhibitors, that led to life-threatening blood and kidney infections. The infections were reported from March 2013 through October 2014, with each infection requiring hospitalization. Some patients have infections that were so severe they were admitted to an intensive care unit, or placed on dialysis to stop their kidneys from failing.
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[text] => Leg and Foot Amputations
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[text] => An ongoing clinical trial, known as Canagliflozin Cardiovascular Assessment Study (CANVAS), found people taking Invokana were twice as likely to need their leg or foot amputated. CANVAS researchers studied patients for more than one year. The researchers developed the following amputation risk ratio:
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[text] => 7 out of every 1,000 patients treated with 100 mg daily of canagliflozin
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[text] => 5 out of every 1,000 patients treated with 300 mg daily of canagliflozin
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[text] => 3 out of every 1,000 patients treated with placebo
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[text] => Approved by the FDA in March 2013, Invokana was marketed as a new, first-class solution to controlling diabetes. Today, Invokana approval only extends to type II diabetes because the drug lacks an established safety profile for type I treatments.
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[text] => Canagliflozin, alongside dapagliflozin and empagliflozin, are classified as SGLT2 inhibitors. Although SGLT2 inhibitors are the new kids on the block, they’ve dominated the market.
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[text] => But a high number of adverse event reports sparked concerns about the safety of the drug, prompting the FDA to take action and issue five safety alerts.
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[text] => 6.14.2016
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[text] => FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)
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[text] => FDA Drug Safety Communication: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate
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[text] => 9.10.15
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[text] => FDA Drug Safety Communication: FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density
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[text] => Via fda.gov
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[text] => 2015 Safety Communications
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[text] => From March 2013 to June 2014, the FDA documented 20 cases of acidosis in patients who had been using the drug for about two weeks. After many of these patients ended up hospitalized or in an emergency room, the FDA reinvestigated the safety of the drug.
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[text] => In May 2015, the FDA issued a warning about Invokana’s connection to ketoacidosis. The regulatory body has received hundreds of adverse event reports since.
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[text] => In September 2015, the FDA extended Invokana’s Warning and Precaution and Adverse Reactionssections to include the loss of bone density. The FDA has ordered the manufacturer to add the risk of bone fractures to the labeling.
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[text] => The FDA acknowledged that the labeling on Invokana and Invokana-metformin combination drug Invokamet already includes the risk of bone fractures, but the recent addition comes from new studies that show bone issues will occur more frequently.
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[text] => In December 2015, the FDA notified the public about SGLT2 drugs causing too much acid in the blood and serious urinary tract infections. The announcement came after the FDA identified 73 cases of ketoacidosis and 19 life-threatening urinary tract infections.
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[text] => The FDA released information from the CANVAS clinical trial to illustrate the risk of amputation linked to Invokana, which mostly affects the toes. The agency continues to investigate the particular side effect.
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[text] => Most recently, the FDA extended an additional kidney-related public announcement in June 2016, linking Invokana to acute kidney injury. Acute kidney occurs when the kidneys stop filtering waste, which then builds up in the body.
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[text] => “We urge health care professionals and patients to report side effects involving canagliflozin, dapagliflozin, or other medicines to the FDA MedWatch program,” the FDA wrote.
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[text] => A Major Moneymaker
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[text] => One out of three people will develop type II diabetes in their lifetime, which makes the manufacturing of diabetes medications extremely profitable. The amount of drugs on the market has created a fiercely competitive atmosphere. Adding additional risks to warning labels could seriously affect reputation, which drives down profits for the drug manufacturer.
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[text] => While the FDA is in the process of assessing the danger of new-age diabetes drugs, ProPublica reported that Johnson & Johnson spent over $7 million on the drug’s endorsement and marketing. Insurance systems like Medicare also contribute to the frequency of their prescription.
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[text] => Since the drugs were approved in 2013, Invokana and Invokamet have been bringing in big bucks for Johnson & Johnson. The pair brought in a total $318 million in the second quarter and hit $596 million in the first half of 2015. Their advertising strategy has led Invokana to be one of the highest earning drugs of its class.
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[text] => Rising Cost of Diabetes Care
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[text] => Diabetes is a complex condition that requires daily attention. As more and more Americans develop the disease, the cost of general care and support for side effects only grows.
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[text] => “The economic burden associated with diagnosed and undiagnosed diabetes, gestational diabetes mellitus, and prediabetes was estimated to be 48% higher than that reported in 2007,” according to the journal Diabetes Care. “For 2012, the estimated total burden exceeded $322 billion, comprising $244 billion in excess medical costs and $78 billion in reduced productivity.”
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[text] => More than 1.7 million people over the age of 20 were diagnosed with diabetes in 2012. The CDC now estimates that as many as 1 in 3 U.S. adults could have diabetes by 2050.
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[text] => While the FDA continues to investigate, many diabetics may be prescribed Invokana. Diabetic patients using the SGLT2 inhibitors could face broken bones, amputated limbs and ketoacidosis emergencies. Some will spend weeks in the hospital recovering from a cardiac problem or critical infection.
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[text] => The FDA has become increasingly aware of the complications, which damages and degrades vital parts of the human body. As the agency works to inform the public about the dangers, support for individuals surviving Invokana side effects continues to grow.
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AbbVie Inc. Rejects $140M AndroGel Verdict
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[text] => Last month, the U.S. District Court in Northern Illinois awarded $140 million to plaintiff Jeffrey Konrad after he suffered a heart attack following prescribed use of AndroGel. Manufactured by AbbVie Inc., AndroGel is a topical replacement testosterone therapy for daily use by adult males with low or no testosterone.
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[text] => Just last week, AbbVie publicly rejected the jury’s finding that they “misrepresented and concealed AndroGel’s harmful side effects,” calling for Judge Matthew Kennelly to either reject the verdict or significantly reduce the award amount.
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Mental Health Services Expanded for Some Veterans
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[text] => Just two days after a U.S. Air Force veteran shot and killed 26 people in a Texas church, the House has passed legislation broadening some veterans’ access to mental health care.
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[text] => The Hill reports that until this legislation goes into effect, only veterans with an other-than-honorable discharge are eligible to receive mental health assessments and services. When it does go into effect, it will serve “former military service members discharged under conditions that were not honorable who participated in combat operations or experienced sexual abuse.”
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New Invokana Study Results in Renal Improvement
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[text] => Currently the top prescribed sodium-glucose cotransporter 2 (SGLT2) in the U.S., Invokana has once again been the focus of a renal-based CANagliflozin cardioVascular Assessment Study (CANVAS) spanning over six years. One of the study’s major findings was a 47% reduced rate in end-stage kidney disease.
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[text] => IVC filters were designed to protect against stroke and pulmonary embolism by stopping blood clot migration to major organs. Both retrievable and permanent filters have caused serious complications that involve hospitalization, including inadvertent arterial puncture, and vein or organ perforation.
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Synthetic Hernia Mesh Fails in Latest Study
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[text] => Synthetic hernia mesh has long been reported to cause serious injury and hospitalization. Lawsuits have become recalls after many plaintiffs claim synthetic mesh is not compatible with human tissues. Its plastic composition has led to infections and abscesses. In contrast, biological mesh consists of tissues from cadavers or animals, making incorporation much easier.
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[text] => Due to an increase in hernias, the global hernia mesh market could reach nearly $200 million by the year 2025.
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[text] => In February 2016, an EU-funded Green Nano Mesh was launched in Ireland to create “biodegradable nano- and micro-scale fibrous hernia meshes.” Development research is continuing.
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[text] => When a diabetic gets a small cut, it’s a serious concern. For diabetics, a simple blister, cut, crack or sore can become a dangerous ulcer that could lead to a life-changing amputation.
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[text] => In the past 20 years, the rate of lower limb amputations caused by diabetes complications has decreased by 50 percent. But most diabetics don’t know that the popular diabetes medication Invokana (canagliflozin) can actually worsen their risk.
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[text] => When the diabetes drug Invokana first hit the market in 2013, it was heralded as a breakthrough for patients who wanted to lower their blood sugar and possibly lose some weight, too. But now, many of those hopeful patients are also wondering why does Invokana cause amputations?
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[text] => Diabetes Amputations
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[text] => How common are diabetes amputations?
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[text] => The Centers for Disease Control and Prevention (CDC) estimates 23.6 million Americans currently have diabetes. In the past decade, the number of Americans with diabetes has increased heavily from 18.2 million in 2003.
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[text] => Amputations are a serious concern for people with diabetes. Most amputations are performed on the lower extremities, primarily of the toes and feet. Though it’s less common, some diabetics require amputations below the knee.
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[text] => Nearly 67 percent of U.S. amputations are linked to diabetes and related complications. According to the CDC, about 73,000 non-traumatic lower-limb amputations were performed in adults aged 20 years or older with diagnosed diabetes in 2010.
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[text] => An amputation is the surgical removal of a limb or other body part to extract diseased or dead tissue. Depending on the severity and location, an amputation can severely alter personal identity and limit the ability to participate in daily activities. There’s no doubt that people who experience amputations deal with a lot of pain and suffering.
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[text] => The amputation rate for people with diabetes is 28 times higher than for people without diabetes. Amputations are more common for men than women, with a 50 percent higher amputation rate for male diabetics. The elderly and the non-Hispanic black population are also affected more frequently.
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[text] => Why do diabetics have a higher risk of amputation?
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[text] => There are multiple factors that play a role in amputation. Though many of the issues that create cause for an amputation are related to foot care, some are related to glucose management and unknown medication risks.
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[text] => Nerve damage and poor circulation, worsened by uncontrolled blood sugar, are two major issues that contribute to the need for an amputation. These complications allow infections to set in without a diabetic’s knowledge, causing a gangrenous wound that could later require an amputation.
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[text] => About Invokana and Amputations
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[text] => Certain medications, such as Invokana, can also increase the risk of amputation. Invokana, the trade name for the drug canagliflozin, is prescribed to patients for the treatment of type 2 diabetes. The drug is licensed from Mitsubishi Tanabe Pharma Corporation to Johnson & Johnson’s Janssen Pharmaceuticals division for distribution throughout most of the world.
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[text] => According to Janssen Pharmaceuticals, Invokana lowers blood sugar (A1C) and the 300-mg dose is proven to reduce A1C levels more effectively than a competing drug from Merck called Januvia.
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[text] => What is the reason for the FDA Invokana amputation warning?
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[text] => Known Invokana side effects include ketoacidosis, kidney problems, urinary tract infections and a higher risk of broken bones. Amputation risk, however, is a new concern for users of the popular diabetes medication.
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[text] => In 2017, the U.S. Food and Drug Administration began requiring new ‘black box’ warnings to be added to Invokana labels to describe the increased risk of leg and foot amputations to patients.
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[text] => The FDA acted following two large clinical trials, CANVAS and CANVAS-R, in which the data demonstrated that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with a placebo.
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[text] => What did the Invokana amputation study show?
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[text] => During the clinical trials, the researchers found that patients most often experienced amputations of the toe and middle of the foot. But, other patients had amputations involving the leg, below and above the knee. In addition, some had more than one amputation and some had both limbs amputated.
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[text] => One of every 69 patients who take Invokana for five years will have a drug-related amputation.
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[text] => Despite the increased risk, the trials did not answer the question of why does Invokana cause amputations. According to an article in Forbes, some doctors speculate that while the drug decreases blood sugar and blood pressure, it may also cause the blood to thicken and subsequently pool in the foot.
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[text] => As researchers struggle to explain why the amputations occur, the FDA did make a note of which types of patients might be predisposed to amputation if they decide to take Invokana. The factors that appeared to increase the odds of amputation included a prior history of amputation, peripheral vascular disease, neuropathy and diabetic foot ulcers.
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[text] => About SGLT2 Inhibitors and Amputations
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[text] => Can water pills explain how a certain class of diabetes drugs increase the risk of amputations in people who take the drugs?
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[text] => That question formed the basis of a new study of type 2 diabetes patients presented last month at the European Association for the Study of Diabetes 2018 Annual Meeting, as Medscape Medical News reported. The study was the latest to investigate the controversy around sodium-glucose cotransporter-2 (SGLT2) inhibitors and an elevated risk of amputation.
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[text] => SGLT2 inhibitors, prescribed to help lower blood sugar in adults with type 2 diabetes, are sold under the names Invokana, Farxiga and Jardiance. In 2017, more than 2 million people were prescribed SGLT2 inhibitors to manage high blood sugar, as MedTruth noted.
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[text] => What’s the link between SGLT2 inhibitors and amputation risks?
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[text] => The SURDIAGENE study followed a large group of type 2 diabetes patients who take water pills. Also called diuretics, these medications work to expel water and salt from the body as urine. The research team found that individuals taking water pills had twice as high a risk of lower limb amputations. They suggest the water pills drained patients’ blood volume, so there was less blood and fluid circulating in the body — what’s known as hypovolemia.
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[text] => The scientists theorize that this same hypovolemic effect may account for the heightened risk of amputations seen with the SGLT2 inhibitor canagliflozin, or Invokana. In other words, SGLT2 inhibitors could lead to decreased perfusion — the flow of fluid through the bloodstream — particularly in patients who already have poor leg circulation. And that mechanism might explain the increased danger of amputations among people taking SGLT2 inhibitors.
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[text] => Asked about this theory, Ronan Roussel, MD, PhD, who presented the results and is chief of the endocrinology, diabetes and nutrition department at Group Hôpital Bichat, AP-HP, in Paris, emphasized that the results are "hypothesis-generating," not conclusive. However, he told Medscape Medical News, "If this observation [is accurate], it's probably a class effect.”
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[text] => And while some scientists pointed to confounding factors — such as heart failure — that might explain the results.
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[text] => "The hypovolemia hypothesis could provide an explanation for the increased risk of lower limb amputation observed with SLGT2 inhibitors," Roussel nonetheless concluded.
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[text] => The risk, however, hasn’t been confirmed. Scientists and doctors are working to find more conclusive information about amputation risks and SGLT2 inhibitors.
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[text] => As scientists continue to investigate these risks, the European Medicines Agency has issued a warning that the entire class of SGLT2 inhibitors for type 2 diabetes may raise the risk for lower-limb amputation. In contrast, the US Food and Drug Administration has limited its advisory to one SGLT2 inhibitor — Invokana. However, in September, the agency issued a new safety announcement, warning of a potential link between a rare, destructive bacterial infection and diabetes drugs like Invokana, Farxiga and Jardiance.
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[text] => What are the amputation risks with Invokana, Farxiga and Jardiance?
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[text] => In July, new research published in the peer-reviewed journal Diabetes, Obesity & Metabolism attempted to get to the bottom of the risks around the entire class of SGLT2 inhibitors. The study found a higher rate of amputations among all SGLT2i patients, including individuals taking the SGLT2 inhibitors Farxiga (dapagliflozin) or Jardiance (empagliflozin). The heightened risk, however, was not statistically significant.
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[text] => More recently, a research team in Australia followed a small group of type 2 diabetes patients with open foot wounds, which puts them at greater risk for amputations. One group was taking Farxiga or Jardiance, while a control group of patients was not. Researchers found amputations occurred in both groups, but the control group had a higher rate of amputations (0.60 amputations in the control group compared to 0.41 in the group taking SGLT2 inhibitors), according to the paper published in September in the Journal of Clinical and Translational Endocrinology.
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[text] => “This study is therefore the first to provide real-world data on the use of SGLT2i in patients with open foot wounds and offers some reassurance on the use of empagliflozin and dapagliflozin in people at high risk of amputation," the authors noted.
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[text] => Still, the small size of the study, and conflicting results on the risks of SGLT2 inhibitors, suggests more work needs to be done to help diabetes patients navigate their risks.
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[text] => How to Prevent Diabetic Amputations
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[text] => What are the risk factors for diabetic amputations?
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[text] => Diabetics have sensitive feet that are more vulnerable to injuries, especially when blood glucose in unmanaged. All of the factors that lead to amputations actually work together, so it’s important to be aware of each one.
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[text] => Diabetic neuropathy reduces sensation, making patients unaware they have injuries because they can’t feel wounds developing. Poor circulation, on the other hand, keeps injuries from healing properly. Knowing the risk factors for diabetic amputation are key to prevention.
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[text] => Diabetic Neuropathy
Diabetic neuropathy, a common diabetes complication, is a form of nerve damage caused by high blood sugar. It injures nerve fibers throughout the body, leaving patients with decreased feelings in the lower limbs and feet. Because of neuropathy, diabetics may not feel hot or cold temperatures. They might not notice a cut or callous that makes them more vulnerable to infection.
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[text] => “You could have a tack or stone in your shoe and walk on it all day without knowing. You could get a blister and not feel it. You might not notice a foot injury until the skin "breaks down and becomes infected.”
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[text] => American Diabetes Association
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[text] => There are four types of diabetic neuropathy: peripheral neuropathy, autonomic neuropathy, radiculoplexus neuropathy and mononeuropathy. Symptoms of diabetic neuropathy might include pain, numbness, tingling, burning. For some people with neuropathy, digestive issues, bladder problems, vision complications, erectile dysfunction are experienced.
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[text] => Poor Circulation
Diabetes may affect blood vessels, causing them to narrow, harden. This limits blood flow to the legs and feet. A lack of blood flow can affect the ability to fight infections in addition to slowing the speed of wound healing. Some identifiable indicators of poor circulation include peripheral vascular and arterial disease.
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[text] => Smoking also affects the small blood vessels in the body. Smoking can reduce blood flow throughout the limbs, and it makes injuries harder to heal. Many diabetes who require amputations are smokers.
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[text] => Skin Changes, Calluses, Ulcers
Skin changes, related to nerve damage, affects the natural oils and moisture in the feet. When diabetes affects the skin of the feet and toes, it causes dryness. Dryness makes the skin more likely to peel and crack. If the natural regulatory state of the foot changes, it makes the patient more vulnerable to injury, infection and amputation.
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[text] => Calluses, caused by repeated friction, pressure or irritation, are also more common with diabetes. Untrimmed and untreated calluses can cause complications, which frequently occur on the ball of the foot or on the bottom of the big toe. Calluses may develop into ulcers, which are painful open sores.
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[text] => Neglecting or walking on ulcers can result in deeply embedded infections. Many of these wounds are non-healing, which may lead to the loss of a limb.
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[text] => Invokana
People with diabetes are already at a higher risk of amputation, but studies show the popular medication Invokana can double the risk. The reason for an Invokana amputation is not yet clearly understood. However, researchers confirm that Invokana in conjunction with other risk factors makes amputation more likely.
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[text] => A history of prior amputation may also predispose patients taking Invokana to the need for amputation. Patients with a history of amputation or peripheral vascular disease had the highest amputation risk, but the relative risk was similar. Regardless of a prior risk, diabetic patients are encouraged to talk to their doctors about the potential amputation side effects of Invokana.
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[text] => Most diabetic foot infections require some surgical intervention, but many foot problems are actually avoidable. It’s possible to prevent diabetic foot ulcers and amputations by understanding the risk factors, key elements of proper care and any and all medication risks upfront.
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[text] => The New York Times reports “the European Parliament made Monsanto the first company barred from lobbying the chamber after its executives refused to take part in a hearing over glyphosate.”
Despite this, both the European Food Safety Authority and the European Chemicals Agency have authorized glyphosate’s safety. And in a move suspected to appease working farmers, German Chancellor Angela Merkel has voiced her support for glyphosate.
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[text] => In a fascinating study of public perception meeting hard science, a link has been suggested between testosterone and stock market instability. Approximately 140 males participated in a stock trade simulation for this study, the first of its kind.
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[text] => The Management Science journal revealed, “High-testosterone traders were more likely to deploy a more aggressive strategy: buy high to sell higher.”
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[text] => Amos Nadler, a researcher at the Ivey Business School at Western University, said the results suggest "the need to consider hormonal influences on decision-making in professional settings because biological factors can exacerbate capital risk."
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[text] => Additional studies have indicated the other effects linked to testosterone. Nadler went on to suggest the result of the study is not a new one, and that “cool down” periods on the trading floor could very well mitigate the risk of irrational decisions.
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[text] => Drug manufacturer Janssen Pharmaceuticals has submitted a Supplemental New Drug Application (sNDA) to the FDA, seeking a new indication for INVOKANA® (canagliflozin) “to reduce the risk of major adverse cardiovascular events (MACE), composed of cardiovascular death, myocardial infarction and stroke, in adults with type 2 diabetes who have established CV disease or are at risk for CV disease.”
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[text] => Despite Janssen’s application, Invokana is still under scrutiny. In May of 2017 the FDA issued a black box warning for Invokana, stating it “causes an increased risk of leg and foot amputation.”
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[text] => Covered California sent an email late Friday stating, “Despite this action, Covered California members will not see any change in their health costs for the remainder of 2017 and the rates and out-of-pocket costs published by Covered California for 2018 will not be affected.”
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[text] => Women are statistically at greater risk of contracting STIs and HIV when only the male partner uses a condom.
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[text] => Caring for multiple health issues can be difficult, and for the more than 85 percent of diabetics who are overweight, it may seem like it's impossible to get ahead. A diabetes pill that could maintain blood sugar and simultaneously aid in weight loss might appear to be the perfect fix—especially when it's presented that way in Invokana advertisements.
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[text] => Diabetes and obesity are closely tied, creating a new trend in advertising strategies for pharmaceutical treatments. Invokana ads boasting blood pressure reduction and weight loss, in addition to type A1 management, are becoming increasingly common.
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[text] => But the Food and Drug Administration (FDA) didn't approve diabetes medications to manage weight and blood pressure. And because many diabetes drugs come with dangerous side effects, consumer groups are fighting back.
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[text] => Despite having no approval from the FDA, manufacturers place misleading ads on their websites and in magazines. The organization has asked the agency to put a stop to off-label marketing of five drugs, including:
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[text] => When drugs are taken for unapproved uses, it can lead to a number of side effects. Many of these drugs are linked to urinary tract infections, bladder cancer, pancreatitis, yeast infections, thyroid c-cell tumors, and kidney failure.
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[text] => "In the case of Farxiga and Invokana, blood pressure reduction also is touted as a potential benefit," Public Citizen wrote in the complaint. "This is an especially egregious 'benefit' claim, as hypotension is listed as an adverse effect in the medications’ labels, owing to the diuretic effect and possible volume depletion inherent in the drugs’ mechanism of action."
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[meta_title] => What You Need to Know About Diabetes Drug Side Effects
[meta_description] => MedTruth's National Diabetes Month focus is educating patients on how to handle diabetes drug side effects.
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[text] => More than 29 million Americans have diabetes, a serious condition that can be difficult to manage. Throughout November, communities across the nation are recognizing and participating in National Diabetes Month. At MedTruth, we’re drawing attention to the increasingly common illness with a specific focus on educating patients about how to handle diabetes drug side effects.
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[text] => Also known as diabetes mellitus, this illness can have a debilitating impact on the overall quality of life. In some cases, drugs prescribed to manage a diabetic's blood sugar fluctuations may actually increase the risk of developing more serious complications.
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[text] => 1. Managing diabetes
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[text] => Diabetes medications may be used to control blood sugar and effectively manage the disease.
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[text] => Diabetes may begin at a young age or develop over time. There are three different types of diabetes, each with systemic issues and associated symptoms. Regardless of the specific type, diabetes is defined by issues with insulin.
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[text] => Type 1 Diabetes: The body is unable to make insulin, preventing it from taking blood glucose from food to make energy.
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[text] => Type 2 Diabetes: The body doesn’t make or use insulin well, requiring pills or insulin injections to manage and control blood glucose.
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[text] => Gestational Diabetes: Temporary diabetes during pregnancy may develop, possibly subsiding after childbirth, with a greater chance of returning later in life.
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[text] => The production of insulin is essential for the body to properly function, keep glucose levels balanced and avoid possible medical emergencies. When diet and lifestyle changes aren't enough, doctors may prescribe medications to help manage the disease and keep patients safe from developing insulin reactions that can lead to diabetic shock.
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[text] => A variety of diabetes medications, approved by the U.S. Food and Drug Administration (FDA), have been successful in helping patients control blood sugar. These medications may be associated with:
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[text] => Less thirst and hunger
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[text] => Some medications, however, may come with an increased risk of complications.
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[text] => Tasked with monitoring food, exercise, medication, and other significant health elements, it can be difficult to develop a personalized care plan to manage diabetes. Without proper information, diabetics may not factor in the potential for diabetes drug side effects.
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[text] => 2. Recognizing complications
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[text] => Certain diabetes medications have been linked to an increased risk of developing serious side effects.
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[text] => Type 2 diabetes is the most common variation of the illness, affecting an estimated 90 to 95 percent of diabetes patients. One popular drug class prescribed to manage type 2 diabetes is sodium-glucose cotransporter-2 (SGLT2) inhibitors.
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[text] => Diabetes, potentially compounded by the effects of obesity, leaves individuals prone to a greater risk of health problems. Diabetics already have a higher chance of developing various issues, including:
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[text] => Because diabetics are more likely to have nerve damage and kidney issues, they may not realize their diabetes medication is actually accelerating the development of diabetes-related complications. For some diabetics, diabetes drugs may also lead to an increased risk of developing diabetes drug side effects, including amputation, ketoacidosis and kidney disease.
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[text] => The FDA has released a number of safety communications informing patients about the risks associated with diabetes drug side effects, but many patients taking the medication remain unaware of the signs and symptoms. The first step in avoiding complications is being aware of potential diabetes drug side effects and paying attention to the body's changes to seek medical attention if something doesn't feel right.
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[text] => 3. Seeking assistance
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[text] => Resources may be available for individuals who used diabetes drugs and developed complications.
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[text] => Diabetes medications come with known and unknown side effects, but doctors may not always inform patients of the associated risks. Invokana, a popular SGLT2 inhibitor, can cause a number of diabetes drug side effects.
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[text] => Individuals who used the diabetes medication Invokana may have developed ketoacidosis, experienced kidney issues or required a leg, toe, or foot amputation. The complications are serious, and some may require extended hospitalizations and surgical interventions.
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[text] => Resources and potential compensation may be available for diabetics who have suffered from serious, life-changing complications. Many diabetics currently experiencing complications are unaware that help is out here, and it’s easy to learn more about options for diabetes drug side effects by talking to an advocate.
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[text] => It’s important to improve existing prescribing information and make sure diabetics are aware of how to avoid potential side effects, and what to do if they occur.
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[text] => Living with diabetes is already challenging. At MedTruth, we educate the public about diabetes and take it one step further by offering assistance for patients who may have developed diabetes drug side effects.
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[text] => In this edition of MedTruth Weekly, we discuss Medicaid cuts to nursing homes, Essure's removal from Canadian markets, and more.
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[meta_title] => MedTruth Weekly: Risperdal Petition, Medicaid Cuts To Nursing Homes
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[text] => MedTruth Weekly delivers the latest developments in medical research, regulation, legislation and legal actions. The best way to be an advocate for yourself is to know the facts. Staying informed starts here.
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[text] => Medicaid funds more than 1.4 million people in nursing homes, but budget issues have left the program financially stressed. Attempts by the Republican Senate to release new healthcare legislation and repeal the Affordable Care Act could leave elderly individuals without coverage.
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[text] => States allocate a portion of their Medicaid budget to pay for nursing home care. Proposed changes may reduce funding or restrict eligibility for some individuals, requiring families to pay for residential care or altering disabilities to qualifications.
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[text] => Change.Org Launches Petition To Stop Prescribing Off-Label Risperdal To Children
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[text] => Change.org, a powerful platform for crowdsourced digital advocacy, has sponsored a petition to raise awareness about breast growth risks linked to Risperdal. Risperdal, an antipsychotic approved to treat adults diagnosed with schizophrenia and bipolar disorder, is often prescribed to children and adolescents, leaving them with serious complications.
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[text] => The medication has been prescribed for off-label indications to treat ADD, ADHD, and autism. Change.org's petition aims to spread awareness of the illegal prescribing practice to prevent young boys from developing the breast growth side effect, medically known as gynecomastia.
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[text] => The permanent birth control implant Essure has repeatedly made headlines in 2017 as its manufacturer, Bayer, continues to pull the device from global markets. After removing Essure from Finland, the Netherlands, and the United Kingdom, Bayer will discontinue sales in Canada. The company cited “commercial reasons” and “change in patient demand.”
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[text] => Studies and advocacy groups have raised awareness about the potential side effects of Essure, impacting revenue and prompting the device's removal from numerous countries. Sales of Essure had also been suspended in Brazil, as the country's National Health Surveillance Agency deemed it “a measure of health.”
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[text] => A research letter published on June 8 in the New England Journal of Medicine outlines a study that assessed the risk of developing diabetic ketoacidosis when taking Invokana and other SGLTS inhibitors. Ketoacidosis is a potentially fatal medical emergency that occurs when the body produces too much blood acids.
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[text] => The study included 50,220 patients treating type 2 diabetes with SGLT2 inhibitors and 90,132 patients taking DPP-4 inhibitors, another class of diabetes medications. Results show that SGLT2 inhibitors double the risk of ketoacidosis, with about 5 to 8 per 1,000 patients developing the disease.
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[text] => People with diabetes taking Invokana and other SGLT2 inhibitors may be at risk for Fournier's gangrene, a flesh-eating bacterial infection affecting the groin and genitals. SGLT2 inhibitors that may potentially cause Fournier's gangrene include Invokana, Farxiga and Jardiance.
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[text] => On Aug. 29, the Food and Drug Administration (FDA) released a safety announcement warning of a potential link between a rare, destructive bacterial infection and diabetes drugs like Invokana, Farxiga and Jardiance.
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[text] => Known as Fournier’s gangrene, the bacterial infection affects the genitals. The FDA has warned the development of the infection may be related to the use of sodium-glucose cotransporter-2 (SGLT2) inhibitors, a class of diabetes drugs that will soon feature updated labeling.
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[text] => What is Fournier's Gangrene?
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[text] => Fournier’s gangrene, also referred to as necrotizing fasciitis of the perineum, is a rare disease with few known causes. Some potential causes may be a urinary tract infection, anal abscess or other pelvic injuries.
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[text] => Fournier's gangrene, initially known as fulminant gangrene, was discovered in the late 1800s. Today, it is named after Professor Jean-Alfred Fournier, a dermatologist and venereologist who researched the condition, according to Hindawi.
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[text] => There have been more than more than 1,800 cases recorded in medical history, according to the National Organization of Rare Disorders. Fournier's gangrene affects people between the ages of 50 and 79, and typically impacts men more than women. The condition is often found in individuals with other diseases, including diabetes.
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[text] => Identifying the First Signs of Fournier's Gangrene
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[text] => Fournier's gangrene is a rare but serious medical condition, with symptoms that can accelerate quickly. It begins with a cut that leads to an infection in the space between the anus and genitalia (perineum), but it can spread to the legs, torso, and chest.
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[text] => The first signs of Fournier's gangrene are often pain and tenderness in the groin or pelvic region. As Fournier's gangrene continues to develop, redness and swelling may start to appear.
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[text] => When Fournier's gangrene becomes serious, patients may experience a fever of 100.4 F and a rapid heartbeat, according to Healthline. An unpleasant smell or rankness is commonly reported, in addition to an unusual sound of gas moving or tissue crackling when the area is touched.
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[text] => Patients should contact a physician and seek immediate medical treatment if any symptoms of Fournier's gangrene appear. Depending on the stage of the condition, Fournier's gangrene may require hospitalization or additional surgeries.
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[text] => In 2017, an estimated 1.7 million people were prescribed SGLT2 Inhibitors to control high blood sugar. Diabetes is a daily struggle that can be stressful, tiring, and even dangerous. It's crucial that diabetes medications given to patients are safe and reliable.
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[text] => According to the FDA, the onset of Fournier’s gangrene typically begins after nine months. The FDA advises anyone taking the medications listed below to immediately contact their doctor to be tested for Fournier’s gangrene.
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[text] => SGLT2 medications may also be linked to amputation of the toes, feet, or lower legs. Because diabetics are more prone to amputation, it's often difficult to identify SGLT2 inhibitors as the cause of an increased risk. The FDA has also issued an update on the prescribing information and the patient medication guides for SGLT2 inhibitors.
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[text] => After receiving 12 reports of Fournier's gangrene in diabetes patients taking SGLT2 inhibitors, the agency issued the safety announcement. On average, the patients had been taking SGLT2 inhibitors for 9.2 months, though the range was one week to 25 months.
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[text] => "All 12 patients were hospitalized and required surgical debridement. Five required more than one surgery, and one required skin grafting," according to Medscape. "Four patients developed complications, including diabetic ketoacidosis, acute kidney injury, and septic shock. One patient died, and two were transferred to a rehabilitation hospital."
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[text] => Widespread antibiotics can slow or stop it in the early stages. If given time, Fournier’s gangrene can kill flesh in the infected areas requiring amputation and reconstructive surgery. Common symptoms can include pain and discomfort in the affected area, which may escalate into necrosis in months.
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[text] => The Food and Drug Administration (FDA) has updated warnings on four diabetes medications to minimize the risk of acute kidney injury. Used to treat type II diabetes, canagliflozin and dapagliflozin are sodium-glucose cotransporter-2 (SGLT2) inhibitors that work with the kidneys to maintain safe blood sugar levels.
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[text] => Drug costs in the United States are comparably expensive to other countries. Some Americans drive to Mexico for their medications, others drive to Canada. But for those who aren’t near a bordering nation, the idea of buying medicine online becomes increasingly attractive.
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[text] => The market for online pharmacies has grown exponentially in the last few years, creating concerns about the legality and safety of ordering pharmaceuticals from a digital provider. In response to the rise of digital pharmacies, the Food and Drug Administration (FDA) released guidelines on how to buy medicine online.
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[text] => Referred to as “rogue online pharmacies” by the FDA, these digital stores may not require proof of prescription for purchase. Rogue online pharmacies offer discounts, but they may be selling unapproved or imitation medicine.
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[text] => Many of these rogue sites claim to be based in Canada. Because there’s no way to actually verify their location, it’s possible that these pharmacies are located on the opposite end of the globe.
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[text] => Another reason online pharmacies may be dangerous is that pharmaceuticals may not contain critical FDA warnings about prescribing information, drug interactions and common side effects. For example, if you try to buy Invokana online, you may not receive the regulatory insert that warns patients about an increased risk of amputation.
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[text] => The FDA has created the BeSafeRx program, which helps "raise awareness of the dangers of buying prescription medicines from fake online pharmacies." It includes information on how to identify a fake online pharmacy and how to find a safe online pharmacy.
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[text] => The National Association of Boards of Pharmacy lists of verified and unverified pharmacies. Verified Internet Pharmacy Practice Sites (VIPPS®) bear a seal that indicates the website meets state requirements and other safety criteria. The board also releases a List of Not Recommended Websites, but even if a pharmacy isn’t named here it still may not be a safe alternative.
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[text] => The drug in question, metformin, is commonly prescribed as a first line of treatment for type 2 diabetes, and its gastrointestinal side effects include diarrhea and flatulence.
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[text] => Clinical researcher Dr. Andy McGovern of the University of Surrey said some classes of medication are much easier to take than others, and switching to another class would be easier for the patient.
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[text] => While failure to take medication for diabetes may result in eye disease or kidney damage, there are still drugs on the market such as Invokana, which may cause kidney disease or lead to amputation.
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[text] => In one of the more unfortunate mesh outcomes, a woman in rural England is pushing for a ban on vaginal mesh after her own implantation shrunk, cut through her vaginal wall, and mutilated her partner’s genitals during intercourse.
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[text] => Theresa Bartman had her vaginal mesh implanted in 2007 and had it removed in 2015 after years of unbearable pain and developing abscesses. She now lives with chronic pain and post-traumatic stress disorder.
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[text] => Indiana resident Lynn Hartman made news after winning a hard-fought battle against pharma giants Bayer Healthcare and Janssen Pharmaceuticals. A Philadelphia jury awarded Hartman $28 million in damages after she suffered severe side effects, including gastrointestinal bleeding, while using the anticoagulant Xarelto.
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[text] => It was the first legal outcome resulting in a loss for Janssen, Bayer, and Xarelto, having won the previous three suits brought against them. And there are 20,000 more Xarelto-related suits yet to face.
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[text] => This is our last MT Weekly roundup for 2017.
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[text] => All of us at MedTruth thank you for joining the revolution, and we wish you a very happy and healthy 2018!
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[text] => Though more than 30 million people across the U.S. currently suffer from diabetes, taboos still linger. It's important to seek out resources and information to help you offer better diabetes support to friends and family.
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[text] => Studies have found that strong home foundations lead to more success managing the disease with diet and medication. Diabetes support systems can also help alleviate physical, mental, and emotional discomfort for patients.
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[text] => 1. Seek Diabetes Support Resources
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[text] => In addition to daily changes, learn about the specific drugs used to manage each individual case of diabetes. When diabetes drugs are introduced to the daily regimen, possibly in combination with other medications, it may cause diabetes drug side effects, such as amputation and ketoacidosis. Side effects are another burden, and they can be severe.
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[text] => When blood sugar drops, people with diabetes begin to experience a slew of uncomfortable symptoms. The Diabetes Council stated: “Low blood sugar levels can cause confusion and anxiety, while high blood sugar levels can cause increased fatigue, concentration issues, and even may lead to periods of depression.”
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[text] => Keep an eye out for symptoms of low blood sugar. Familiarize yourself with the foods that are safe for diabetics, and the foods that aren't. If you think something seems off, take a moment to assess the situation and help carry out the steps needed to get blood sugar back to a healthy level.
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[text] => Communication may help you offer more personalized diabetes support. According to researchers, it turns out talking about your feelings can actually help fight diabetes. Studies show it can help reduce diabetes-related distress and promote "psychological well-being, health-related quality of life, and general self-care.”
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[text] => Once you gauge how comfortable your friend or family member is discussing their diabetes, ask if you could accompany them to a medical appointment, or offer to help them shop for diabetes-appropriate foods and plan healthy meals.
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[text] => Type 2 diabetes is incurable, and continued assistance may be required due to diabetes burnout, which occurs when the patient grows tired of managing their condition. As well as extending kindness to the patient, remind them to be kind to themselves.
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[text] => A diabetes patient named Sarah Kaye told On Track Diabetes, “I firmly believe that diabetes burnout is much like the saying, ‘Depression is not a sign of weakness; it's a sign of being strong for too long.’”
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[meta_description] => A popular class of diabetes medications in 2019 may cause an increased risk of amputation, in addition to other complications such as diabetic ketoacidosis, acute kidney injury and serious urinary tract infection, SGLT2 amputation creates another risk for patients with diabetes.
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[text] => Gliflozin SGLT2 inhibitors, also known as sodium-glucose cotransporter-2 (SGLT2) inhibitors, are a class of diabetes mellitus medicines which includes canagliflozin, dapagliflozin, and empagliflozin. They are prescribed to adult patients with type 2 diabetes to help control their blood sugar levels, in conjunction with foot care, healthy diet, and regular exercise. These behaviors, however, may not be enough to prevent a side effect of SGLT2 inhibitors, SGLT2 amputation.
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[text] => While Gliflozin SGLT2 inhibitors have been shown to be effective at managing blood sugar in the long term, they have been linked to serious side effects including increased risk of lower limb amputations and genital infections. As newer long-term studies continue to unfold, patients using gliflozin class drugs need to be aware of this growing list of potential issues.
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[text] => Gliflozin, or SGLT2 inhibitors, are a popular drug class prescribed to many diabetics. Gliflozin class drugs are approved for lowering blood sugar in type 2 diabetes patients. Gliflozin works by inhibiting the SGLT2 protein in the kidneys, preventing them from reabsorbing glucose from filtered urine that the kidneys process. Glucose stays in the urine and the body eliminates it through urination.
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[text] => Gliflozin is often used in conjunction with metformin, which is the primary drug used to treat type 2 diabetes patient with poor control of their blood glucose. Combination drugs of canagliflozin and metformin are marketed as Invokament and Invokament XR. In many cases, SGLT2 inhibitors assist patients with their diabetes without causing side effects. However, some patients may experience an adverse event.
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[text] => Side effects of gliflozin include low blood pressure, excessive blood acidity (ketoacidosis), kidney issues, excess blood potassium, serious urinary tract infections, yeast infections, low blood sugar when used with other prescription diabetes medicine, bone breaks, and increased cholesterol.
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[text] => Patients with predisposing factors such as prior amputations, peripheral vascular disease, neuropathy, and diabetic foot ulcers are at a potentially higher risk for lower limb amputation.
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[text] => Common SGLT2 Side Effects
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[text] => SGLT2 side effects may be subtle or minor inconveniences. For some patients, it's difficult to link the side effect to a diabetes medicine specifically.
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[text] => Stop taking canagliflozin if you experience any of the following side effects. Immediately contact a healthcare professional for emergency medical treatment if you have experienced or are experiencing any of the following while taking an SGLT2 inhibitor:
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[text] => ● Increased urination, particularly at night
● Increased thirst
● Constipation
● Dry mouth
● Frequent, urgent, burning, or painful urination
● Noticeable decrease in urine
● Cloudy, red, pink, or brown urine
● Strong smelling urine
● Pelvic or rectal pain
● (Women) vaginal odor, white/yellow vaginal discharge, vaginal itching
● (Men) redness, itching, or swelling of the penis, foul-smelling discharge from the penis, skin pain of the penis
● Tingling in the arms and legs
● Loss of muscle tone
● Weakness or heaviness in the legs
● Lack of energy
● Cold, gray skin
● Irregular or slow heartbeat
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[text] => Stop taking canagliflozin if you experience side effects. Contact a healthcare professional for emergency medical treatment if you experience any of these symptoms of diabetic ketoacidosis as these can contribute to SGLT2 amputation as well as other serious medical conditions:
● Rash
● Hives
● Itching
● Difficulty swallowing
● Swelling of the face, throat, tongue, lips, mouth, or eyes
● Hoarseness
● Nausea
● Vomiting
● Stomach-area pain
● Unusual tiredness
● Difficulty breathing
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[text] => The FDA approved canagliflozin in 2013 as the first gliflozin approved for use in the U.S. for lowering blood sugar in patients who have been diagnosed with type 2 diabetes. Dapagliflozin and empagliflozin are the other two agents in the gliflozin class that has been approved by the FDA. Gliflozin has not been approved for patients with type 1 diabetes.
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[text] => The Risks of SGLT2 Amputations
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[text] => Though amputation as the result of SGLT2 side effects is a life-changing and often devastating end, for many it is not the end of their troubles. SGLT2 amputation carries with it the risk of serious adverse side-effects arising from the surgery.
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[text] => According to a 2018 study published in The BMJ, SGLT2 inhibitors were found to significantly increase the likelihood of diabetic ketoacidosis and SGLT2 amputation. Another 2018 published in the Journal of Clinical And Translational Endocrinology of a randomized controlled trial performed with over 100 volunteers echoes this sentiment stating that among patients with a high baseline risk of amputation SGLT2 inhibitors may tip the scales in favor of SGLT2 amputation.
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[text] => Following an amputation, complications can arise from infection due to amputation bone fracture, as well as decreased immune response following the surgery. The best method to prevent these and other side effects is to talk to your doctor about regulating your SGLT2 inhibitor usage in order to prevent the circumstances leading to SGLT2 amputation.
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[text] => Black Box Warning: Risk for SGLT2 Amputation
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[text] => In 2017, the FDA issued a Boxed Warning (Black Box Warning) for all canagliflozin pharmaceuticals marketed in the U.S. Based on data from two large clinical trials (CANVAS and CANVAS-R), the FDA concluded that canagliflozin causes an almost doubled risk of needing leg and foot amputations for patients prescribed with the drug compared to those without. Learn more about the rates of amputation in our Invokana amputation guide.
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[text] => There are a number of risk factors for amputations, including diabetic neuropathy. The negative side effects of diabetic neuropathy can be mitigated with proper foot care, in addition to regular visits with a primary care physician.
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[text] => Medication Guide Warning: Genital Infection Risk
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[text] => In August 2018, the FDA issued an additional warning for canagliflozin, requiring that drug manufacturers include a warning about an increased risk of genital infections known as necrotizing fasciitis in the patient Medication Guide. While rare, these serious genital infections affect the genitals and the area around the genitals, and result in dead tissue that may result in losing portions of the genitals and surrounding tissue.
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[text] => Also known as Fournier's gangrene, necrotizing fasciitis may start small and worsen over time. Diabetes patients may itch their groin or genital region, and the infection may spread. Diabetes patients have reported a foul smell before visiting the emergency room to have surgical debridement and antibiotic treatment.
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[text] => Drug Safety Communications: SGLT2 Diabetes Medicine
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[text] => Through a series of drug safety communications, the FDA revised labels for gliflozin to include warnings about increased risks for bone fractures due to decreased bone mineral density, excessive blood acidity (ketoacidosis), and urinary tract infections. However, some diabetes patients experienced these side effects prior to being informed about the increased risk of complications.
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[text] => While the FDA has issued a Black Box Warning for canagliflozin specifically, a new 2018 study (SURDIAGENE) from France found that use of diuretics in conjunction with canagliflozin might the reason for the increased risk of leg and foot amputations seen in the studies cited by the FDA. Studies show the potential risk of toe amputations is most common.
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[text] => One of the authors of the study also suggested that his findings could be extended to the full gliflozin class of drugs, but stated that further studies would need to be done to draw real conclusions.
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[text] => The FDA should consider the results of the SURDIAGENE study in its ongoing assessment of gliflozin SGLT2 class drugs, and conduct further studies to assess whether or not diuretics should be contraindicated with gliflozin. SGLT2 inhibitors should be monitored by a primary care physician in order to minimize the risk of SGLT2 amputation.
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[text] => SGLT2 amputation is a serious public health issue. Patients taking a gliflozin class drug should consult their physicians about potential complications from diuretic co-use, as well as other side effects.
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[text] => Male diabetic patients may have to watch out for Fournier's gangrene linked to type 2 diabetes medications known as SGLT-2 inhibitors, according to August 2018 announcement from the FDA.
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[meta_title] => What Diabetics Need to Know About Fournier’s Gangrene
[meta_description] => Male diabetic patients may have to watch out for Fournier's gangrene linked to type 2 diabetes medications known as SGLT-2 inhibitors, according to August 2018 announcement from the FDA.
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[text] => Gangrene is the death of soft tissue and skin in the body due to oxygen starvation or severe bacterial infection. The condition commonly affects extremities, and if not treated fast, can lead to the loss of fingers, toes, and other vestiges.
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[text] => While this health issue is commonly associated with amputated limbs, recent reports indicate that it also affects the genitals - with a disproportionate predominance of occurrences in men.
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[text] => Known as Fournier’s Gangrene, this traumatic condition can shockingly be the result of diabetic treatment.
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[text] => As documented by some accounts on Reddit, Fournier’s gangrene manifests as an extreme bacterial infection of the tissue under the skin around the pelvic regions. Men are considered ten times more likely to develop the condition than women.
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[text] => Once the tissue cells that surround muscles, nerves, fat, and blood vessels of the perineum are affected, usually by a cut or break in the skin, everything gets infected — and death tolls are very high, according to a U.S. Food and Drug Administration announcement.
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[text] => The FDA announced in August that male diabetic patients may have to watch out for certain class of type 2 diabetes called sodium-glucose cotransporter-2 inhibitors, known as SGLT2.
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[text] => The report explained that between March 2013 to May 2018, there were 12 cases of Fournier’s gangrene in patients taking the SGLT2 medication.
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[text] => “All 12 patients were hospitalized and required surgery,” the report stated. “Some patients required multiple disfiguring surgeries, some developed complications, and one patient died.”
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[text] => The fatality rate is believed to be between 20-30 percent of those infected. As of now, there are a little under 2,000 reported cases of the disease ever — and no known cure, as the condition is still too rare to document in an exact way.
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[text] => Historical figures such as Herod the Great, his grandson Herod Agrippa and Puerto Rican abolitionist and pro-independence leader Segundo Ruiz Belvis have died from ‘conditions related to gangrene in the genitals’ themselves. And they’re not the only ones, centuries later, to have issues in that regard.
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[text] => Research from the FDA has shown that there's about 1.6 Fournier’s gangrene cases per 100,000 males annually, and most frequently occur in men 50-79 years old. Although the condition is extremely rare, it is still dangerous if developed.
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[text] => What are these SGLT2 inhibitors that may cause this?
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[text] => Typically, SGLT2 inhibitors are FDA-approved prescription medicines for lowering the blood sugar in adults with type 2 diabetes. They are officially approved to lower the risk of death from heart attack and stroke in adults with type 2 diabetes and heart disease.
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[text] => Medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, and empagliflozin. Common brand names include Invokana, Jardiance, Farxiga and more.
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[text] => They are paired with diet and exercise to help the kidneys exert urine and remove glucose from the body at the same time.
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[text] => The FDA said that more than 1.7 million patients filled a prescription for an SGLT2 inhibitor in 2017. The risk of Fournier’s gangrene is small in context, but the possibility of unreported cases and high mortality rates associated with the condition is serious.
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[text] => It starts with a cut
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[text] => Similar to other types of gangrene, Fournier’s gangrene is a bacterial infection that spurs from a wound, even one as small as a minor cut from shaving or a recent surgery.
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[text] => The cut is close to the genital area and is a gateway for bacteria to spread into crevices on men’s genitals, where they can incubate for long periods of time.
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[text] => The tissue then begins dying and can spread to the thighs, testes, stomach and chest.
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[text] => According to some Reddit accounts, some men have reportedly gotten the gangrene from masturbation — however, extensive masturbation doesn’t in of itself cause the gangrene. Rather, abrasions to a man’s penis caused from masturbation may exacerbate bacteria in a cut that was already there. The soft tissue around the scrotum makes developing the condition even easier.
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[text] => Women may also develop Fournier’s gangrene, but it's much less common because of the lack of crevicing around the vagina.
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[text] => The combination of excess glucose in the bloodstream and urine being expelled can feed infection if the area with abrasions is contaminated — and result in the apparent ‘decay’ of those areas.
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[text] => Symptoms and Treatment
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[text] => Usually, doctors say feverish tendencies, tenderness, redness and soreness in the genital area is a sign one should seek medical treatment.
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[text] => If there is cracked skin and an odor at the infection site, symptoms may even worsen quickly. The infection can move very fast and spread upward to other parts of the body, such as the chest or thighs, if left untreated.
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[text] => Usually Fournier’s gangrene is fought with antibiotics and surgery to remove the dead tissue from the infected area. Patients may need to