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A Hazard to Your Child's Health - An FDA Warning for Paxil on Serious Birth Defects

September 28, 2005 (consumeraffairs.com)

GlaxoSmithKline and the FDA are warning that a study has identified a risk of birth defects, like major congenital malformations in infants born to women taking Paxil and Paxil CR during the first trimester of pregnancy.

A long-term epidemiological study suggested an increase in the risk of overall major congenital malformations for Paxil (paroxetine) and Paxil CR compared to other antidepressants.

"Healthcare professionals are advised to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients," the FDA said.

Labels for Paxil and other antidepressant drugs already include the possibility that the drugs can cause birth defects.

Last month, Norwegian researchers said Paxil is associated with a higher risk of suicide in adults. The drug, which is currently not approved for use by children, has been the subject of 16 scientific reviews, which were analyzed for the Norwegian study.

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see also:

FDA Children Warning Urgent information parents with children on Paxil should know
Stay informed - What you must know about your children and Paxil

Birth Defects Warning For your Baby's Safety - Read the FDA Birth Defects Warning on Paxil
Pregnant and on Paxil? You must read this FDA Warning on Birth Defects

News & Warnings The latest News and warnings on the damage-inducing drug Paxil
Are you up to date? Read the latest Paxil news all users need to know

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