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Warning strengthened on paroxetine birth defect risks

Based on the results of two studies, the Food and Drug Administration
(FDA) paroxetine
free prescription <http://withoutsmoking.com/paroxetine/> has strengthened
its warning on the anti-depressant paroxetine (paroxetine). The FDA stated
in a Dec. 8, 2005, public health advisory that paroxetine increases the risk
of birth defects in women taking the drug during their first trimester of
pregnancy. Women who take paroxetine during their first three months of
pregnancy are nearly two times more likely to give birth to a child with a
birth defect, in particular a heart defect, than are women taking other
anti-depressants, the FDA stated.
Birth Defects

The Food and Drug Administration (FDA) has determined that exposure to
paroxetine in the first trimester of pregnancy may increase the risk for
congenital malformations, particularly cardiac malformations. At the FDA's
request, the manufacturer has changed paroxetine's pregnancy category from C
to D and added new data and recommendations to the warnings section of
paroxetine's prescribing information. Paroxetine is available as paroxetine,
paroxetine CR, Pexeva, and generic paroxetine hydrochloride. The FDA's
conclusions and changes in paroxetine's prescribing information are based on
preliminary analyses of two recent unpublished epidemiology studies.
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