US Reinforces Warning on Paxil Link to Birth Defects
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08 December, 2005 20:49 GMT
Two studies of pregnant women taking Paxil during their first trimester have shown their babies have heart defects one and a half to two times a greater rate than the norm.
The government's drug regulation agency is strengthening its warning that the antidepressant Paxil may be associated with birth defects, citing a new study that found increased risk of fetuses developing heart defects.
The
Food and Drug Administration asked manufacturer
GlaxoSmithKline to reclassify the drug, which goes by the generic name paroxetine, as a "Category D" drug for pregnant women.
The classification means that studies in pregnant women have shown a risk to the fetus. However, the agency said, the benefits of the drug may outweigh the risk to the fetus.
First Trimester
Two studies of pregnant women taking Paxil during their first trimester have shown their babies have heart defects one and a half to two times a greater rate than the norm, the agency said. The agency announced the strengthened warning Thursday. It issued a previous warning in September.
The agency is advising doctors not to prescribe Paxil to women in their first three months of pregnancy or people who are planning to become pregnant, unless there are no other options.
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