Announced on December 8, 2005
Consumer Inquiries: 888-INFO-FDA
The Food and Drug Administration (FDA) has alerted health care professionals and patents who take Paxil about the preliminary results of a new Paxil ( Paroxetine ) study. The early findings suggest that Paxil increases the risk for birth defects, especially heart defects, when taken during the first three months of pregnancy.
Paxil is used for treating depression and other psychiatric disorders, and is currently approved by the FDA. However, the agency is now requring updated labeling for this anti-depression pharmaceutical drug.
The FDA advises the health care industry to discuss the potential risk of birth defects with female patients who plan on getting pregnant, or who are within their first trimester of pregnancy. Those who fall within these categories should consider discontinuing Paxil, and possibly switching to another antidepressant if necessary.
However, the FDA is also stressing that women should not, at this point, disscontinue the use of Paxil before discussing the option with their physician.
The early results of these two studies showed that women who took Paxil during the first three months of pregnancy were about 1.5 to 2 times as likely to have a baby with a heart defect than women who received other antidepressants, or women who did not take any antidepressant.
According to an FDA press release, “Most of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart).” These types of defects usueally range in severity from minor (may resolve without treatment) to those that cause serious symptoms and may need to be repaired surgically.
FDA has asked the Paxil’s manufacturer, Glaxo Smith Kline ( GSK ), to change the pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risks to the fetus.
Additional information concerning today’s announcement is available on FDA’s Web site.