Updated Product Labeling Warns of Birth Defect Risk with Paxil

Medical Author: Melissa Conrad Stoppler, MD
Medical Editor: Dennis Lee, MD

The U.S. Food and Drug Administration (FDA) recently announced that early research studies with the drug Paxil (paroxetine) suggest that taking the drug during the first three months of pregnancy may increase a woman's risk of having a baby with birth defects, particularly heart defects.

Paxil is an antidepressant drug belonging to the class of medications known as the selective serotonin reuptake inhibitors (SSRIs). Drugs in this group affect levels of the chemicals that nerves in the brain use to communicate with one another, known as neurotransmitters. Many experts believe that an imbalance among the amounts of the different neurotransmitters in the brain leads to depression. The SSRI class also contains fluoxetine (Prozac) and sertraline (Zoloft). Paxil is approved by the FDA for the treatment of depression and several other psychiatric disorders.