SSRI Antidepressants & Birth Defects

Paxil® Side Effects

Controversy continues to surround the antidepressant drugs Paxil®, Paxil CR®, Pexeva® and its generic equivalent paroxetine hydrochloride. Manufactured by GlaxoSmithKline (GSK), Paxil® is a selective serotonin reuptake inhibitor (SSRI), widely prescribed for the treatment of depression, generalized anxiety disorder, social anxiety disorder, panic disorder, and obsessive compulsive disorder (OCD). Since its approval for use in the United States, a number of potentially life-threatening side effects have been linked to Paxil®, including an increased risk of birth defects in pregnant mothers as well as severe withdrawal symptoms in patients who stop taking the drug.  The most serious of which are birth defects in children born to mothers who took Paxil® during pregnancy.

Paxil® linked to birth defects

Recent medical studies have revealed that expectant mothers prescribed Paxil® are at a higher risk of giving birth to a baby with a birth defect than women taking other forms of antidepressant. Specifically, experts believe that fetuses exposed to Paxil® during the first trimester are at a much higher risk of developing ventricular septal (hole in the heart) and other cardiovascular defects. In addition research also points to an increased chance of developing the potentially fatal condition – persistent pulmonary hypertension.

Cardiovascular birth defects associated with Paxil®

  • Hypoplastic Left Heart
  • Pulmonary Atresia
  • Tricuspic Atresia
  • Transposition of the Great Vessels
  • Pulmonary Stenosis
  • Coarctation of the Aorta
  • Tetralogy of Fallot
  • Double Outlet Right Ventricle
  • Persistent Truncus Arteriosus
  • Interruption of the Aorta
  • Double Inlet Left Ventricle
  • Double Aortic Arch

In 2005, the FDA determined that “exposure to Paxil in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations.”  The FDA also requested, GSK change Paxil’s pregnancy category from C to D and add further Warnings to the prescribing information issued with the drug. Yet despite these warnings and the obvious links to a variety of life-threatening illnesses, both Paxil® and paroxetine remain on the market.

If you or your child has been injured as a result of exposure to Paxil® or paroxetine, Burg Simpson’s award-winning dangerous drug lawyers would be happy to review your records to determine whether you have a viable case against GlaxoSmithKline or any other manufacturer. Call toll-free 1-888-895-2080 or email us to schedule a free consultation today.


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Burg Simpson E-News: February 2020

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