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Potential Paxil Side Effects Pose Challenging Decision

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Boston, MAWhen women who are depressed discover they are pregnant, they face many challenging questions, including whether or not Paxil side effects or the side effects of other antidepressants will cause harm to their unborn baby. Concerns about possible Paxil birth defects could weigh on their minds while they attempt to determine whether the risks of having untreated depression compare with the risk of potential Paxil side effects. But women who have been involved in a Paxil lawsuit say they were not given adequate information about Paxil side effects to make that decision.

Lawsuits filed against the maker of Paxil, GlaxoSmithKline, allege the company knew or should have known about the risks associated with Paxil, specifically the risks to unborn babies who were exposed to the drug. Women say their children had serious birth defects, including congenital malformations, which resulted in their infants undergoing surgeries and other medical procedures to treat their birth defects.

Paxil is not the only selective serotonin reuptake inhibitor (SSRI) to be linked to congenital birth defects, but it does have a stronger pregnancy category than other SSRIs. In 2005, Paxil was moved from a pregnancy category C drug to pregnancy category D. Pregnancy category D indicates that there is evidence of harm to human fetuses, although the benefits of taking the drug may still outweigh the risks.

When the US Food and Drug Administration (FDA) made its announcement about the change in pregnancy category, it noted that two studies had linked the use of Paxil during the first trimester with an increased risk of babies born with heart defects. Specifically, the studies found an increased risk of atrial and ventricular septal defects (holes in the walls of the chambers of the heart).

The increased risk of birth defects ranged from 1.5 to 2 times the risk shown in babies whose mothers had taken other antidepressants during the first trimester of pregnancy.

The issue is that although there are potential side effects to taking Paxil while pregnant, there are also risks to having untreated depression while pregnant. Women who are taking Paxil and are pregnant or plan on becoming pregnant should weigh the risks of each and talk to their doctors if they have concerns.


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