The FDA assigns drugs into pregnancy categories to assess the risk of injury to a fetus. According to the FDA, there are five of these categories: A, B, C, D, and X. Category A represents the weakest warning, with each subsequent category increasing in severity up to category X, which is reserved for drugs that pose the most serious risk to a fetus.
SSRI drugs (selective serotonin reuptake inhibitors) used to primarily treat depression fall into either category C or D. Category C drugs indicate that there may be a risk to fetal development based on studies conducted in animals, and category D drugs may cause harm to a fetus based on studies and research in humans.
Women who took the drug while pregnant had an increased risk of delivering a child with cardiovascular problems.
In December of 2005, the FDA announced a warning about the potential risks of taking the SSRI Paxil during pregnancy. Women who took the drug while pregnant had an increased risk of delivering a child with cardiovascular problems. In July the following year, the FDA warned women who took SSRIs after their 20th week of pregnancy were six times more likely to have a child with persistent pulmonary hypertension of the newborn, a condition that causes lung problems and breathing issues, than those who did not.
In compliance with FDA regulations, manufacturers are required to update consumer information regarding the potential side effects of their medications whenever a warning is announced, including those concerning a drug’s effect on pregnancy. If a manufacturer fails to provide sufficient information about the risks associated with their medications, they may be liable for resulting damages. If you or a loved one took an SSRI during pregnancy and delivered a child with a birth defect, you may be eligible for financial compensation. Contact our SSRI birth defect attorneys for a free case evaluation by completing the form on the right.