The Food and Drug Administration said Thursday that the warning label on GlaxoSmithKline’s widely-prescribed anxiety drug Paxil has again been revised to advise the drug may cause heart defects in babies.
According to an agency release, two clinical studies have now indicated that pregnant women who take Paxil early in their pregnancy run about a 1.5% to 2% risk of bearing a child who has a hole in their heart. Expectant mothers who didn’t take the drug ran about a 1% risk.
The extent of the heart defects ranged from mild to those that were severe enough to require surgery.
The FDA said that based on the data, it is asking that Paxil’s drug classification be changed from “C” to “D”. Doctors use the classification system to decide whether or not to prescribe a specific drug to a woman who is pregnant.
Despite the warning, the FDA said that Paxil’s benefits may outweigh its risks for certain patients. Paxil is also known by the generic name paroxetine.
The FDA noted that Glaxo (GSK ) had changed its label in September to reflect results from one of the clinical studies. The agency said it now asked the company to update Paxil’s label to now include results from the second study.
In September, Glaxo also sent out letters to health professionals advising of the labeling changes for pregnant women, according to the FDA’s website.
Like many other popular antidepressants, Paxil also carries a warning advising that it can trigger suicidal thoughts in some children and adolescents. The drug is not approved for pediatric use.
Paxil was first approved by the FDA in December 1992.