GlaxoSmithKline (NYSE: GSK) has changed the Paxil® (paroxetine hydrochloride) labeling to reflect updated epidemiological studies which show that infants born to women who had first trimester exposure to paroxetine had an increased risk of cardiovascular malformations.

The most common malformations in the studies were ventricular and atrial septal defects.

In general, septal defects range from those that are symptomatic and may require surgery to those that are asymptomatic and may resolve spontaneously.

Prior to this labeling change, Paxil was designated as a Pregnancy Category C drug denoting caution about potential risks if the drug is used in pregnant women. In the revised labeling, Paxil is now in Pregnancy Category D. The label recommends that physicians:

* Advise patients who become pregnant while taking paroxetine about the potential harm to the fetus.

* Consider discontinuing paroxetine or switching to another antidepressant unless the benefits of paroxetine to the mother justify continuing treatment.

* Initiate paroxetine in women who intend to become pregnant or are in their first trimester of pregnancy only after considering other available treatment options.

"GSK has worked with the FDA to make these labeling changes and to communicate the updated findings for Paxil so physicians and patients can make well-informed treatment decisions," said Dr. Jack Modell, GSK vice president of Clinical Psychiatry - North America.

More detailed information on the studies are being disseminated in a letter to healthcare professionals. Findings from the epidemiological studies and the US label changes are being communicated to other regulatory agencies in countries where paroxetine is marketed, and action there initiated as appropriate. For additional information about the studies, the revised labeling for Paxil and Dear Health Care Professional letter can be found on gsk.

Paxil ® has been approved by the FDA for treatment of depression, generalized anxiety disorder, social anxiety disorder, panic disorder, obsessive compulsive disorder and post traumatic stress disorder. Paxil CR is approved for the treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder.

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View drug information on Paxil CR.