New Study Confirms Increased Cardiovascular Risks from Diabetes Drug Avandia
Drug Developments
In 2010, European and U.S. regulators took coordinated action stemming from concerns about increased risk of cardiovascular events such as heart attack and stroke from type 2 diabetes drug Avandia, also sold as the generic rosiglitazone. European regulators banned the drug while U.S. regulators restricted its use to patients who’d exhausted other medications and had been informed of cardiovascular risks. That the drug is still available at all in the U.S., however, is due to the lack of conclusive evidence about Avandia’s cardiovascular risks.
Now, a new study published last week in The BMJ (formerly the British Medical Journal) provides results based on data from a systematic review and meta-analysis of 130 clinical trials. The results are in: Avandia may raise risk of heart attack, heart failure and cardiovascular deaths as well as non-cardiovascular deaths by 33%.
C-Section General Anesthesia Raises Risk of Severe Postpartum Depression
Women's Health
Compared to local anesthesia in a hospital in New York State, general anesthesia during C-section (Caesarian section) is associated with a 54% increased risk of postpartum depression and a 91% increased risk of suicidal thoughts and self-inflicted injury, according to a study published late January in the journal Anesthesia and Analgesia.
The findings of this review of more than 428,204 discharge records spanning 2006 to 2013 are observational in nature and do not prove cause and effect. Out of the 428,204 cases, 34,356 cases used general anesthesia and qualified for analysis. While prior research has suggested an association between general anesthesia and increased post-operative depression compared to local anesthesia, this is the first study to look specifically at the effects of general anesthesia on postpartum depression following caesarian deliveries.
Upon confirmation of their preliminary findings, researchers cautioned against the use of general anesthesia for C-sections whenever possible and urged the provision of mental health screenings, counseling and related services for those exposed to general anesthesia.
Tenet Healthcare Settles “Unnecessary Pacemakers” Suit for $1.4 Million
Device News
Dallas-based Tenet Healthcare, a Fortune 500 multinational healthcare services corporation and its Desert Regional Medical Center in Palm Springs, California, have agreed in a federal California court to settle a False Claims Act lawsuit by paying the federal government $1.4 million, the U.S. Department of Justice announced Tuesday. The lawsuit alleged that Tenet charged Medicare for medically unnecessary pacemakers that were implanted into patients at Tenet’s Palm Springs hospital. The lawsuit was filed by whistleblower Michael Grace, a former Desert Regional employee who called out Tenet and the hospital for a scheme, launched in 2014, to defraud the federal government.
This latest is just one of several healthcare fraud scandals and settlements by Tenet in recent years. Additional claims against another Tenet hospital and a Tenet staffing and management services provider are currently pending.
Federal Court Waters Down Definition of “Made in USA” Pharmaceuticals
Legal Developments
The U.S. Court of Appeals for the Federal Circuit, which is headquartered in Washington, DC, has upended longstanding government criteria for which pharmaceuticals can be considered made in the U.S. in a ruling announced Monday.
The Federal Circuit panel upheld the ruling of a lower court that the origin of the active ingredient in a hepatitis drug manufactured by New Jersey-based Acertis Healthcare does not determine the drug’s country of origin. Instead, the panel decided that a drug can be considered made in the U.S. when it is manufactured or “substantially transformed” in the U.S.
The case under consideration challenged a Veterans Administration decision that the agency couldn’t procure Acertis’ hepatitis drug because the active ingredient was manufactured in India, and the VA can only procure domestically manufactured pharmaceuticals.