| Glaxo's Paxil linked to birth defects
Associated Press | September 28, 2005
GlaxoSmithKline PLC warned doctors that its Paxil drug may be more closely linked to birth defects than other antidepressants, according to a letter published Tuesday on the Food and Drug Administration Web site.
The company said preliminary results from a retrospective analysis of women taking antidepressants during the first trimester of pregnancy found more birth defects associated with Paxil than other medications. The birth defects were typical of those in the general population, with the most common being holes in the wall that separates the ventricles of the heart.
GlaxoSmithKline is changing the drug's label to reflect this data. Previously, the label said that there were no adequate and well-controlled studies in humans to determine the effect of the drug on a fetus.
Glaxo noted that the results conflict with other studies, making it difficult to know if Paxil actually causes birth defects.
American depositary shares of the British drug maker closed earlier down 41 cents at $50.81.
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