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Wednesday, 29 June 2011
Paxil During Pregnancy - Category D - Prescribing Information (Part - 3M)

PAXIL PRESCRIBING INFORMATION

In December 2005, the pregnancy precaution for Paxil CR and Paxil was revised to a Pregnancy Category D.(1) These revisions are based on updated data from two epidemiological studies showing that infants born to women who had first trimester paroxetine exposure had an increased risk of cardiovascular malformations, primarily ventricular septal defects (VSDs) and atrial septal defects (ASDs) (see Epidemiological Data section of this letter for further details).

Some information contained in this response may be outside the approved Prescribing Information.This response is not intended to offer recommendations for administering in a manner inconsistent with its approved labeling. This product is designated Pregnancy Category D. If you become aware of patients who have received this product at any time during their pregnancy, we encourage healthcare professionals to report such information to the company. In order for GlaxoSmithKline to monitor the safety of our products, we encourage healthcare professionals to report adverse events or suspected overdoses to the company at 888-825-5249.

Please consult the attached Prescribing Information. This response was developed according to the principles of evidence-based medicine and, therefore,references may not be all-inclusive.

POSTED BY: DW AT 12:38 pm   |  Permalink   |  E-mail this
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