Paxil Users v GlaxoSmithKline
GlaxoSmithKline Updates Paxil and Paxil CR Prescribing Information
GlaxoSmithKline and the FDA notified healthcare professionals of changes to the pregnancy/precautions section of the prescribing information for Paxil and Paxil CR Controlled-Release Tablets. Glaxo's studies suggest Paxil may be more likely to be linked to birth defects than similar drugs.
The manufacturer of Paxil, GlaxoSmithKline Plc, is alerting physicians about the results of a study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy. The company, in a letter posted on the Food and Drug Administration Web site, said it was adding the information to the prescribing instructions on Paxil's label. Glaxo added that most of the defects were cardiovascular in infants born to women who took the drug during the first trimester of pregnancy.
"Preliminary results suggest an increase in the risk of congenital malformations associated with the use of Paxil as compared to other antidepressants," the company's letter to physicians said. "The preliminary results of this study and recent abstracts ... differ from previous epidemiologic studies, making it difficult to conclude whether a causal relationship exists," it said.
The FDA states that physicians should "carefully weigh the potential risks and benefits of using paroxetine (Paxil) therapy in women during pregnancy and should discuss these findings as well as treatment alternatives with their patients."
Legal Action
Law Firms are currently investigating claims relating to Paxil and Paxil CR use during pregnancy. If your baby suffered birth defects as a result of using Paxil during your pregnancy, our attorneys may be able to assist you.
