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Use of Paroxetine in First Trimester of Pregnancy May Have a Small Increased Risk of Birth Defects, Compared to Other Antidepressants

PUBLIC ADVISORY Health Canada Endorsed Important Safety Information on Paxil (paroxetine)

Oct 7, 2005 | Health Canada GlaxoSmithKline Inc., following discussions with Health Canada, is informing patients of new safety information regarding the use of paroxetine during the first trimester of pregnancy.

Paroxetine is used for relieving the symptoms of depression and anxiety. As a result of this new safety information, GlaxoSmithKline recommends the following:

    * As per the current Consumer Information for paroxetine, women who are currently taking paroxetine and are pregnant, or planning on becoming pregnant, should discuss with their doctor the potential risks and benefits of using paroxetine therapy during pregnancy.
    * Doctors have been advised of this new safety information, and are encouraged to discuss the risks and benefits of using paroxetine during pregnancy with their patients.
    * Due to the risk of discontinuation symptoms, it is very important that patients do NOT stop taking paroxetine without first consulting with their doctor.

Preliminary results of a recent study conducted by GlaxoSmithKline, suggest there may be a small increase in the risk of birth defects, compared to other antidepressants, in babies whose mother took paroxetine in the first trimester of pregnancy. Specifically, increased risk was reported for overall frequency of birth defects, and in the frequency of heart-related defects.

Of the heart-related defects reported, the majority were ventricular septal defects (holes in the muscular wall that separates the right and left ventricles of the heart). This is a common type of birth defect that can spontaneously occur, and the vast majority of cases are mild and spontaneously reverse within a few years after birth. The majority of babies born to women taking paroxetine in this study were born healthy.

The Product Monograph for PAXIL® (paroxetine hydrochloride tablets) and PAXIL CR™ (paroxetine hydrochloride controlled release tablets) currently includes a precaution that paroxetine should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. The Product Monograph also includes information related to possible symptoms and complications observed in newborns exposed to paroxetine during the third trimester of pregnancy.

GlaxoSmithKline has sent a letter to healthcare professionals informing them of this new safety information.

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