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.
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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.