Paxil, Paxil CR or Pexeva (generic: paroxetine hydrochloride) is manufactured by GlaxoSmithKline. On December 8, 2005, the FDA determined that exposure to paroxetine in the first trimester of pregnancy may increase risk for congenital malformations, particularly cardiac malformations. At the FDA’s request, the manufacturer has changed paroxetine’s pregnancy category from C to D and added new data and recommendations to the warnings section of paroxetine’s prescribing information. Paroxetine is available as Paxil, Paxil CR, Pexeva, and generic paroxetine hydrochloride.
Paxil May Cause Neonatal Persistent Pulmonary Hypertension
On July, 2007, the FDA issued additional black box warnings for the increased risk of Neonatal Persistent Pulmonary Hypertension. Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies. Babies with PPHN can be very sick and may die.
If your baby was born with PPHN or another malformation and you were taking Paxil during pregnancy, you may have a legal claim. Please contact Daniel P. Kondos today. Attorneys are available my phone, e-mail or by clicking here.