Pregnant Women, the FDA and Warnings
Word is getting out about the risks to an unborn fetus if the mother takes Paxil. The wheels sure grind slowly, though. The initial FDA www.fda.gov warning for women expecting a baby was in September 2005. The FDA based its warning on two studies, the first of which found double the risk of heart defects in babies born to mothers who took Paxil early in their pregnancy, compared to the risk in the general population.
Three months later, the FDA ordered GlaxoSmithKline www.gsk.com to reclassify Paxil from a Category C to D (a stronger warning) for pregnant women. Category D means studies in pregnant women demonstrated this risk to the unborn baby. The most common defects were cardiovascular, or heart problems.
It took another year for the American College of Obstetricians and Gynecologists (ACOG) www.acog.org to get around to issuing its own warning. Finally, the ACOG Committee on Obstetric Practice recommended that paroxetine [Paxil] use among pregnant women or women planning to become pregnant be avoided, if possible, due to these risks. You can see the warning at www.acog.org/from_home/publications/press_releases/nr12-01-06-1.cfm.