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news.GlaxoSmithKline and the FDA have issued a warning that the company's antidepressant Paxil could be associated with a higher incidence of birth defects in children born to women taking the drug during the first trimester of pregnancy.
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The concerns are based on a study that showed a 4% incidence of birth defects in children whose mothers took Paxil during the first trimester of pregnancy, compared with a 2% incidence in babies whose mothers took other antidepressants in the same period of pregnancy.
GSK has now changed the label on the medication to reflect the new found concerns, and an FDA statement released earlier this week advised healthcare professionals 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.”
Although the data from the study has prompted GSK to change the label on the product, the company did also point out that it is difficult to know whether Paxil really does cause a higher risk of birth defects as data from the study may have been affected by other variables.