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 Paxil - Class Action Information

On September 27, 2005, the FDA released an alert to healthcare professionals and consumers as GlaxoSmithKline changed the warning label on Paxil (also known as paroxetine) to include the risk of birth defects. The results of a recent study suggests an increased risk of babies born with birth defects, specifically cardiovascular defects or congenital malformations, in instances where the mother was taking Paxil during the first trimester of pregnancy.

Congenital malformations are physical defects present at birth and may involve the brain, heart, lungs, liver, bones, or intestinal tract. Congenital malformations are currently the leading cause of infant deaths in the U.S.

Paxil, an antidepressant drug, is used by millions of people worldwide and generates more than $1 billion toward GlaxoSmithKline's annual sales. Paxil has previously been in the news for complaints of severe withdrawal symptoms as well as risks of suicidal behavior and increased violence in children and adolescents. Paxil is known as a Selective Serotonin Reuptake Inhibitor (SSRI) similar to Prozac, Zoloft, Celexa and Lexapro.

The FDA warned physicians to carefully weigh the potential risks and benefits of prescribing or renewing Paxil prescriptions to women during pregnancy or while breast-feeding. It is important that all patients are aware of the side effects, risks, and treatment alternatives.

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