Early results of new studies of GlaxoSmithKline’s (GSK) blockbuster antidepressant Paxil (paroxetine) show an increase in the risk of congenital birth defects when pregnant mothers taking the drug within the first three months of pregnancy, the FDA said today.
The agency is gathering additional data and waiting for the final results of the studies in order to better understand the higher risk for birth defects that has been seen with Paxil, the FDA said.
Paxil is approved for the treatment of depression and several other psychiatric disorders.
According to preliminary results of two recent studies, Paxil increases the risk of congenital malformations, particularly cardiovascular malformations.
“Patients taking paroxetine who become pregnant or who are currently in their first trimester of pregnancy should be alerted to the potential risk to the fetus,” the agency wrote in an alert issued today. “Discontinuing paroxetine therapy or switching to another antidepressant should be considered for these patients.”
A GSK spokeswoman told the Web site CNNMoney, “We obviously have worked with the FDA and we’re moving forward to make this information available to health care professionals and patients so that informed treatment decisions can be made.”
