WASHINGTON, Sept. 27 (Xinhuanet) -- The US Food and Drug Administration (FDA) reported Tuesday a retrospective study has suggested that GlaxoSmithKline's antidepressant Paxil may cause birth defects.
The study revealed that babies born to women who took Paxil regularly during the first trimester of pregnancy had birth defects more often than those born to women on other antidepressants, according to the FDA and the company.
GlaxoSmithKline said it will include the results of the study in the product labeling of the drug, or paroxetine in generic form. In a letter the company sent to health care professionals, it said the increased birth defects included heart defects.
The letter was released by the FDA Tuesday.
GlaxoSmithKline called for a cautious prescription of the drug for pregnant women. Meanwhile, the drugmaker said it has not concluded that there exists a definite, causal link between the drug and the increased incidence of birth defects. Enditem
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