Law Articles

Return to Law Dictionary Index

Paxil May Increase Risk of Birth Defects

Source: U.S. Food and Drug Administration

Paxil, an antidepressant drug, may increase the risk of birth defects for pregnant women taking it during the first trimester, the Food and Drug Administration warned last week.

The warning comes after Paxil manufacturer GlaxoSmithKline sent the FDA and doctors a letter about preliminary results from a study suggest an increase in the risk of congenital malformations associated with the use of Paxil (paroxetine) as compared to other antidepressants.

The types of congenital malformations, which were most commonly cardiovascular, were reflective of those seen in the general population. The most common cardiovascular malformations observed in the study were ventricular septal defects.

Septal defects are sometimes called a "hole" in the heart. It is estimated that nearly 1 percent of babies are born with this condition. In the vast majority (80-90%) of babies born with this condition, the hole is small. They will have no symptoms, and the hole will close spontaneously as the muscular wall continues to grow after birth.

Glaxo added that the preliminary results of this study and recent abstracts published by Alwan & Wogelius differ from previous epidemiologic studies, making it difficult to conclude whether a causal relationship exits.

Healthcare professionals are advised to carefully weigh the potential risks and benefits of using Paxil therapy in women during pregnancy and to discuss these finding as well as treatment alternatives with their patients.

Read Full Story at U.S. Food and Drug Administration

Return to Health Law

Return to Law Dictionary Index