Early study results for Paxil (paroxetine) suggest the drug increases the risk of birth defects, in particular heart defects, when women take it during the first trimester of pregnancy. Paxil is approved to treat depression and several other various psychiatric conditions. The FDA is currently gathering additional data and waiting for the final results of the studies to understand further the higher risk of birth defects.
The FDA is advising health care professionals to discuss this potential risk with women who plan to become pregnant or that are in their first pregnancy trimester. Health car professionals should consider discontinuing Paxil and switching to another medicine for these patients.
“Stopping this medicine on your own will in most cases create more problems then it is solving,” says Sandra Kweder, M.D., deputy director of the FDA’s Office of New drugs. “Many of these medicines are associated with withdrawal syndromes, which can be problematic for many patients and stopping is something that needs monitoring by a doctor.”
The FDA asked Paxil’s manufacturer, GlaxoSmithKline (GSK) of Research Triangle Park, to change the drug’s pregnancy category from C to D which is a stronger warning. Category D means the studies on pregnant women have demonstrated risk to the fetus.
In September 2005, GSK updated the drug’s labeling to add data from one study. As additional data is available the label is being changed to reflect the latest reported data.
The FDA has asked Paxil’s manufacturer, GlaxoSmithKline (GSK) of Research Triangle Park, N.C., to change the drug’s pregnancy category from C to D, which is a stronger warning. Category D means that studies in pregnant women have demonstrated a risk to the fetus.
GSK updated the drug’s labeling in September 2005 to add data from one study. As additional data have become available, the label has been changed to reflect the latest data.