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FDA requests a change to Paxil's drug label to include the risk of birth defects - consumers are concerned promotes free case evaluations by U.S. law firms for women and newborns adversely affected by the antidepressant, Paxil.

Wilmington, North Carolina (October 3, 2005) The FDA has recently released the results of a study looking at the link between the antidepressant medication Paxil (paroxetine) and birth defects. With confirmations that the drug may increase the risk of birth defects after taking the antidepressant during pregnancy, consumers are concerned. To seek help, consumers submit their complaints to in hopes of legal representation and compensation.

The study, conducted by the FDA and the maker of Paxil, GlaxoSmithKline, reviewed the medical records of 3,581 infants born to women who took Paxil or other antidepressants during the first trimester of pregnancy. The results showed that 4% of these babies had cardiovascular defects or congenital malformations. Congenital malformations are currently the leading cause of infant deaths in the U.S. and are described as physical defects present at birth involving the brain, heart, lungs, liver, bones, or intestinal tract. Some common defects include heart problems, cleft lip, cleft palate, Down syndrome, spina bifida, or limb defects.

Paxil, an antidepressant drug, is used by millions of teens and adults worldwide to treat depression, panic disorder, social anxiety disorder and other psychological disorders. The drug was launched nearly 10 years ago by GlaxoSmithKline and continues to generate more than $1 billion USD in annual sales. Paxil has also been in the news for complaints of severe withdrawal symptoms and risks of suicidal behavior and increased violence in children and adolescents.

In the recent heath alert, the FDA asks physicians to inform their patients of this danger and carefully weigh the potential risks and benefits of prescribing or renewing Paxil prescriptions to women of child-bearing age.

To support parents with newborns affected by birth defects, Greg Jones & Associates, a North Carolina-based law firm, in association with, provides free legal evaluations. For more information visit:

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