In June 2003, British health regulators issued warnings against prescribing Paxil to children, citing the risk of suicide and violence in children and teenagers.

These warnings followed reported studies which revealed that Paxil could increase the risk of suicide by three times in adolescents under the age of 18.

Thereafter, the FDA reported similar findings, and continues to explore connections between Paxil and an increased rate of suicide and suicide attempts. Reports of suicide and other significant problems led the FDA to recommend that Paxil not be used in young children and adolescents for the treatment of major depressive disorder.

The FDA noted in its warning that Paxil was not approved for use in children or adolescents and the drug is ineffective for treatment of major depressive order among younger patients. The FDA cited three clinical trials that failed to demonstrate Paxil offered any benefit to children suffering from major depressive disorder.

In spite of the apparent health risks among children, the manufacturer of Paxil nonetheless has requested FDA approval that would allow doctors to prescribe Paxil to children and adolescents. That application currently is pending, although influential policymakers have expressed concerns over the application.

In a press release issued June 13, 2003, U.S. Senator Charles E. Schumer asked the FDA to expedite a study intended to assess suicide risk among children on Paxil and place a hold on the British's company request to sell the drug to children in the United States.

Senator Schumer noted in a letter to the FDA about Paxil that the British government's health agency already had banned sales of Paxil to children and adolescents. He questioned why the British company should be allowed to sell the drug in the United States to children when it already was banned by the British government.

As you know, GlaxoSmithKline is itself a British company. The fact that Paxil has been banned for children in its home country underscores the importance of the United States completing its own study as quickly as possible to ensure that our kids aren't made more suicidal by a drug that's supposed to do exactly the opposite.

A Wyoming jury found that Paxil was the leading cause of the deaths of four people following a murder-suicide in which a Paxil patient killed his wife, daughter and granddaughter before killing himself. The jury awarded $8 million to the family of the victims.

Exploring the link between Paxil use and suicide, the FDA reports that suicide attempts and suicidal thoughts are three times greater among adolescent Paxil users versus those given a placebo. The risk may be even greater according to a warning issued May 12, 2006 involving a study with Paxil users aged 18 to 30.

A Fox News report in November 2002 reported suicide attempts may be as much as eight times more likely for patients on Paxil versus a placebo.

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.

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