May 12, 2006—The FDA warned doctors Friday that the antidepressant Paxil may increase the risk of suicide in adult users. The agency previously had warned that the drug was associated with greater incidences of suicide among adolescents.

The warning comes as a result of a clinical trial involving nearly 15,000 patients ranging in age from 18 to 30. Half of those patients were given Paxil, and the other half were given a placebo. Among those who were provided Paxil, there were 11 suicide attempts. There was only 1 suicide attempt in the group given the placebo.

In 2004, the FDA strengthened the warning label on Paxil to address suicidal tendencies among patients under the age of 18.

June 2, 2004—The State of New York filed suit against GlaxoSmithKline, the manufacturer of Paxil. The lawsuit alleged that GlaxoSmithKline intentionally withheld negative information about Paxil and misrepresented data involving its safety in children and adolescents.

The lawsuit further alleged that GlaxoSmithKline conducted five studies on the use of Paxil in children, but failed to publish four of those studies due to negative results. Those studies showed that Paxil increased the risk of suicide and was not effective in the treatment of depression.

After this lawsuit was filed against GlaxoSmithKline, the company released data from clinical trials confirming many of the allegations levied against it by the State of New York. The data indicated both that Paxil was ineffective in depressed adolescents and increased the incidences of suicidal thoughts in those patients.

As part of the settlement announced August 26, 2004, GlaxoSmithKline will release more information in its control concerning safety problems with Paxil and will pay $2.5 million to the State of New York

Paxil, generally known as paroxetine HCI, has been shown by various studies to induce suicide tendencies in some patients. The drug, introduced into the the United States in 1992, was approved by the Federal Food and Drug Administration (FDA) for treatment of depression, panic disorder, obsessive compulsive disorder and social anxiety disorder.

The drug only was approved for use in adults, although the potentially dangerous drug frequently is prescribed to children and adolescents.

If you or a loved one has been injured by taking Paxil, you may be entitled to compensation. You should act immediately to contact an attorney experienced in matters involving dangerous pharmaceuticals.

At O'Steen & Harrison, we understand that suicide or its attempt is a highly sensitive subject for all those involved. If you or a loved one has been affected by this possible Paxil-related event, be assured that we are sensitive to your need for confidentiality.

We will represent patients throughout the United States. We can help you, too, wherever you live.

For free answers to your questions about the Paxil lawsuit, please call us toll-free at
1-800-883-8888 or complete this online contact form.

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FDA Warns of Suicide Risk for Paxil
Yahoo! News
May 12, 2006

Glaxo Settles Paxil Lawsuit
CBS News
August 26, 2004

Warning Issued Against High Doses of Paxil
MSNBC
March 11, 2004