Were you taking Paxil or Paxil CR? Were you properly warned of the potential Paxil birth defect risks during pregnancy? Does your baby have a heart defect or heart problems? Do you want to join a Paxil class action lawsuit?
FDA MedWatch alert – September 2005
GlaxoSmithKline and the FDA notified doctors of changes to the Pregnancy/PRECAUTIONS section of the Prescribing Information for Paxil and Paxil CR Controlled-Release Tablets. The possibility of Paxil birth defects may be more significant than previously believed.
The letter described the results of a GlaxoSmithKline retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy. This study of 3,481 pregnant women suggested an increase in the risk of overall major congenital malformations for paroxetine (generic for Paxil) as compared to other antidepressants. Healthcare professionals are advised to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients.
The new Paxil label states that the drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Australia's drug watchdog, the Therapeutic Goods Administration, reported that as a result of the above study, one in 25 babies born to mothers taking Paxil had a birth defect. Half of the birth defects were heart problems, but most was non-life threatening. The study also found that women who took Paxil instead of other antidepressants during the first trimester of pregnancy were more likely to have a child with a birth defect. Birth defects normally occur at a rate of about three in 100. Heart defects occur one in every 100 to 200 babies.
As a mother, were you warned about the potential of Paxil birth defect risks during pregnancy?
Does your baby or child have a heart defect?
Are you eligible to participate in a Paxil class action lawsuit?
Contact knowledgeable Paxil lawyers today for a no-obligation free consult.