Paxil Linked to Serious Birth Defects
FDA Update: Increase in the Risk of Birth Defects
Preliminary results of two recent studies indicate that Paxil (paroxetin) increases the risk of congenital malformations, particularly cardiovascular (heart) malformations and defects. Based on the new data, paxil's pregnancy category is being changed from C to D. Patients taking paxil who become pregnant or who are currently in their first trimester of pregnancy should be alerted to the potential risk to the fetus. Discontinuing paxil therapy or switching to another antidepressant should be considered for these patients. For individual patients, however, the benefits of continuing paxil may outweigh the potential risk to the fetus. Paxil should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant.
The FDA is currently awaiting the final results of the recent studies and accruing additional data pertaining to the use of paxil in pregnancy in order to better characterize the risk of paxil.
In September 2005, the Food and Drug Administration issued a warning that Paxil (Paroxetine) may be linked with certain birth defects. The warning was based on a study that showed an increase in the number birth defects in babies whose mothers took Paxil during the first trimester of pregnancy. The study compared the rate of birth defects in Paxil mothers with with women on other antidepressants and found Paxil increased the likelihood of birth defects. The birth defects included malformed heart structures and heart problems. After the FDA announcement, Paxil's manufacturer, Glaxo Smithkline, will now include birth defects in the drug's list of precautions.
Paxil is listed as a "Category D" drug for pregnant women - which means that there are no complete studies of its effects on unborn children.
According the company: Doctors are warned "to carefully weigh the potential risks and benefits of using Paroxetine therapy in women during pregnancy. It is recommended that health care providers discuss these latest findings ... as well as treatment alternatives, with their patients."
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