BEIJING, Dec. 12 (Xinhuanet) -- The US Food and Drug Administration has warned doctors that the antidepressant Paxil, when used during the first trimester of pregnancy, increases the risk of congenital heart defects in the developing fetus.
The FDA is advising doctors not to prescribe Paxil to women who are in their first three months of pregnancy or to women who are planning to become pregnant, unless there are no other options.
Women who are taking Paxil should talk to their doctor before going off the drug, the FDA said.
The advisory is based on results of two studies that showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population.
The defects are most often holes in the walls of the heart's chambers. Some were minor; others could require surgery.
The FDA said it asked Paxil's manufacturer, GlaxoSmithKline, to change the drug's label to upgrade the pregnancy warning from a category C to a category D, a higher level warning. The company changed the label two months ago to add data from one of the studies. The latest label change reflects data from both studies, the FDA said.Enditem
(Agencies)
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