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Paxil gets stronger warning Legal Evaluation

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Paxil Gets Stronger Warning

December 2005

After months of alerting doctors about Paxil’s risk to pregnant women, the Food and Drug Administration (FDA) is making it official.

The FDA requested GlaxoSmithKline classify the antidepressant drug as “Category D.” This classification means that studies show that there is an elevated risk to the unborn child in pregnant women. Two studies of expectant mothers taking Paxil during the first trimester indicated their babies were twice as likely to have heart defects.

The FDA requests that doctors do not prescribe the drug to pregnant women in their first trimester unless the benefits outweigh the risk.

For more information about Paxil, visit the Dangerous and Recalled Drugs Legal Center.

Please note: All of our lawyers are licensed to practice in the state of Pennsylvania. We also have lawyers licensed to practice in Ohio, and West Virginia and we associate with experienced attorneys in other states. In addition, all drug-related litigation involves co-counsel.

Source: “FDA Strengthens Warning on Antidepressant Paxil.” The Associated Press. December 8, 2005.

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