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The Food and Drug Administration (FDA) has concluded that exposure to paroxetine during pregnancy can increase the risk for congenital malformations, in particular, cardiac malformations. Per the FDA’s request, the manufacturer has changed paroxetine’s pregnancy category from C to D and now added new data and recommendations to the Warning section of paraxetine’s prescribing information.

Paroxetine is available as Paxil, Paxil CR, Pexeva and generic paroxetine hydrochloride. The FDA’s conclusion in paroxetine prescribing information is based on preliminary analyses of two recent unpublished studies.

• In a study using Swedish national registry data, women who received paroxetine in early pregnancy had an approximately 2-fold increased risk for having an infant with a cardiac defect compared to the entire national registry population (the risk of a cardiac defect was about 2% in paroxetine-exposed infants vs. 1% among all registry infants).

• In a separate study using a United States insurance claims database, infants of women who received paroxetine in the first trimester had a 1.5-fold increased risk for cardiac malformations and a 1.8-fold increased risk for congenital malformations overall compared to infants of women who received other antidepressants in the first trimester. The risk of a cardiac defect was about 1.5% in paroxetine-exposed infants vs. 1% among infants exposed to other antidepressants.

• Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed. In general, septal defects are one of the most common type of congenital malformations. They range from those that are symptomatic and may require surgery to those that are asymptomatic and may resolve on their own. It is of note that the data in these studies was limited to first trimester exposures only, and there are not currently data to address whether this or any other risk extends to later periods of pregnancy.

The FDA is waiting on final results of recent studies acquiring additional data related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations in association with paroxetine. In the meantime, the FDA is recommending the following suggestions:

Physicians who are caring for women receiving paroxetine should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy. Discontinuing paroxetine therapy should be considered for these patients. In individual cases, the benefits of continuing paroxetine may outweigh the potential risk to the fetus. If the decision is made to discontinue paroxetine and switch to another antidepressant or cease antidepressant therapy, paroxetine discontinuation should be undertaken only as directed in the prescribing information. Paroxetine should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant in the near future.

Women that are pregnant, or planning to become pregnant and currently taking proxetine should meet with their doctor to discuss whether they should continue taking it. However, women should not stop using the drug without first discussing it with their doctor.

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