Thursday, September 29, 2005

Paxil may be fatal for Pregnant Women in the first trimester

The accepted antidepressant Paxil could raise the threat of birth defects if expecting women take it at some point in the first trimester, federal health officials announced late Tuesday.

The Food and Drug Administration placeed the caution on its Web site after the drug's maker, the British group GlaxoSmithKline, sent the agency and doctors a letter that cited proof from a latest study. Glaxo said in the correspondence that it had altered the drug's label to reflect the likelihood of the increased danger.

Some doctors who examined the letter said it was not clear whether the F.D.A.'s admonition was necessary. The Glaxo study was an investigation of medical records from a managed care corporation, and did not provide believable proof that it was the drug, and not some other reason, that was responsible for the amplified risk, they said.

According to Dr. Timothy Oberlander a pediatrician at the University of British Columbia and BC Children's Hospital in Vancouver "Typically in studies like this you can't control for other things that could have contributed to the increased rate of defects, like the severity of the mother's depression".

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