Paxil is an antidepressant linked to birth defects and autism. Despite numerous Paxil side effects, the drug is prescribed to thousands of pregnant women each year.


The Truth

Studies + Science

Regulation Recap

The Next Steps
Paxil has been linked to a number of birth defects, including cleft lip, heart problems, and skull defects.Exposure to Paxil has been linked to a threefold increase in the risk of autism.The FDA added a Black Box Warning to Paxil.Resourcecs for families affected by Paxil are available today.

 

The Truth

Paxil, also known as paroxetine, is a drug used to treat depression and anxiety. It’s a selective serotonin reuptake inhibitor (SSRI) that treats depression, anxiety disorders, obsessive-compulsive disorder (OCD), and premenstrual dysphoric disorder (PMDD).

Manufactured by GlaxoSmithKline (GSK), Paxil is one of six SSRI antidepressants available in the United States. The popular drug should not be taken during pregnancy.

Studies + Science

How Paxil Works

As an SSRI, Paxil works by targeting the neurotransmitter serotonin. Neurotransmitters are chemicals in the brain used to communicate. Serotonin is a chemical associated with feelings of happiness, and Paxil works by preventing its reuptake.

Paxil’s Uses

  • Panic disorder
  • Social anxiety disorder
  • Generalized anxiety disorder (GAD)
  • Post-traumatic stress disorder (PTSD)
  • Obsessive-compulsive disorder (OCD)

Paxil is also approved to manage symptoms of menopause, like hot flashes. But there are a number of off-label uses for the drug as well, such as sexual dysfunction, chronic headaches and diabetes-related conditions, such as tingling in the limbs.

Common Side Effects

Common side effects of Paxil include:

  • Headache
  • Dizziness
  • Weakness
  • Difficulty concentrating
  • Nervousness
  • Forgetfulness
  • Confusion
  • Extreme tiredness
  • Nausea or vomiting
  • Diarrhea
  • Constipation
  • Gas
  • Stomach pain
  • Heartburn
  • Changes in ability to taste food
  • Decreased appetite
  • Changes in sex drive or ability
  • Dry mouth
  • Sweating
  • Yawning
  • Sensitivity to light
  • Tightness in the throat
  • Back pain or pain in the muscles, bones, or other parts of the body
  • Tenderness or swelling of joints
  • Muscle weakness or tightness
  • Flushing
  • Sore teeth and gums
  • Strange dreams
  • Painful or irregular menstruation

Serious side effects can also occur. If you have any of these side effects, stop taking paroxetine and call your doctor right away:

  • Blurry vision
  • Hallucinations (seeing and hearing things that do not exist)
  • Fainting
  • Rapid, pounding, or irregular heartbeat
  • Chest pain
  • Trouble breathing
  • Seizures
  • Abnormal bleeding or bruising
  • Tiny red spots directly under the skin
  • Peeling or blistering of skin
  • Signs of infection, such as sore throat, fever, chills, and cough
  • Unsteady walking
  • Sudden involuntary muscle twitching or jerking
  • Numbness or tingling in your hands, feet, arms, or legs
  • Frequent urination
  • More difficult or painful urination
  • A painful erection that lasts for hours

In The Data

Studies show that during pregnancy, Paxil can cause debilitating side effects. Babies exposed to Paxil during the first, second and third trimesters of pregnancy are at risk of autism and other birth defects.

A 2014 study conducted at Johns Hopkins discovered Paxil could increase the risk of autism by three times, specifically in baby boys.

In a 2015 study published in JAMA Pediatrics, researchers at the University of Montreal linked Paxil to double the likelihood that a baby would be born with autism.

A full list of the defects include:

  • Cleft lip and cleft palate
  • Clubfeet
  • Developmental issues
  • Spina bifida
  • Persistent Pulmonary Hypertension (PPHN)
  • Hypoplastic Left/Right Heart Syndrome (HLHS)
  • Heart defects
  • Brain and skull defects
  • Intestinal/abdominal defects
  • Miscarriage
  • Premature birth

Regulation Recap

Paxil was approved by the FDA in 1992. Initially marketed by GSK, Paxil’s popularity grew quickly. Within 15 years, Paxil became the fifth most popular antidepressant in the U.S.

Though Paxil has been prescribed to more than 18 million people, there have been a number of regulatory actions taken to inform patients about the safety of the drug.

2004 Black Box Warning

Similar to Prozac, Lexapro, and Zoloft, Paxil carries the most serious FDA warning. Like other drugs in its class, Paxil may increase the risk of suicide in adolescents and young adults.

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.

2005 Pregnancy Category Update

In 2005, the FDA required GSK to update the product labeling to include a higher risk of pregnancy. The agency mandated that women should be made aware of the likelihood that children could be born with atrial and ventricular septal defects, or holes in the walls of the chambers of the heart. The defects ranged in severity.

FDA has asked the manufacturer to change the pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus.

2005 Recall

Problems at the manufacturing plant required a recall.

GlaxoSmithKline

The billion-dollar pharmaceutical juggernaut has been taken to court on numerous occasions for issues with the packaging and labeling of Paxil. Legal battles indicate that the company could have been legally positioning the drug to be prescribed to children and purposefully hiding crucial safety information.

2012 Settlement

The pharmaceutical company was criminally indicted and paid $3 billion for promoting two drugs off-label. When promoting drugs for unapproved uses, people may be severely injured.

In the case of Paxil, prosecutors alleged GSK helped publish a medical journal article that misrepresented data from a clinical trial and exaggerated Paxil’s ability to treat depression in adolescents.

The manufacture of such a strong SSRI had the responsibility to warn mothers of the risks. Women working hard to overcome depression and anxiety had the right to know about the dangers of taking Paxil and make the choice for themselves and their families.

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