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Federal Paxil Probe Over Suicide Link Widens

Posted by Jane Akre
Friday, June 20, 2008 10:53 PM EST
Category: Major Medical, Protecting Your Family, In The Workplace
Tags: FDA and Prescription Drugs, Defective Drugs, Dangerous Drugs, Antidepressants, Suicide

Paxil probe by the Justice Department into what Glaxo knew about suicide link and when.

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IMAGE SOURCE: Wikimedia Commons/paroxetine (Paxil)/author: Tokino 

 

GlaxoSmithKline PLC’s (GSK) antidepressant drug, Paxil is the focus of a U.S. Justice Department probe that appears to be widening.

At question is how the drug was marketed, and whether research on Paxil’s potential link to suicidal behavior in adolescents and adults was revealed to drug regulators in the U.S.

A Colorado-based investigation into Glaxo’s marketing of Paxil is being coordinated with the U.S. Attorney’s office in Boston by the Justice Department in Washington.

Several families are suing Glaxo and federal investigators have asked them what information they have on Paxil’s link to suicidal behavior and the marketing used on doctors and the FDA.

Senator Charles Grassley, (R-IA) wants the FDA to review findings that Glaxo hid information it knew about suicide risks for 15 years or more.

This follows the release of a British report by the drug safety agency there, which charges that Glaxo has known about Paxil’s risk of suicide since 1998, and intentionally withheld important safety data.

“If the company engaged in this behavior in the U.K., than I want to make sure that the same didn’t happen here in the U.S. The FDA should investigate this question thoroughly and be forthcoming about its findings,” said Sen. Grassley in a statement. 

As several parents prepare lawsuits against Glaxo, a report for litigation by Dr. Joseph Glenmullen, a psychiatrist at Harvard University, concurs that GSK knew as far back as 1989 that Paxil was linked with an increase in suicidal tendencies.  

For example, Sen. Grassley asked GSK when the company learned Paxil was associated with a risk of suicide? Not until February 2006, the company answered in a letter.  But UK investigators found the company had data back in 1998 that patients under the age of 18 had a higher risk of suicide.

“Essentially, it looks like Glaxo SmithKline bamboozled the FDA,” says Sen. Grassley.

He is asking that the FDA look at the same drug information as British investigators obtained.  

Grassley is working on legislation that would require drug companies to certify to the FDA that they provided complete and accurate data regarding the efficacy of their products. 

Any violations would be subject to civil and possibly criminal charges.  #


1 Comment

Posted by paxil sucks
Saturday, June 21, 2008 6:35 AM EST

I was prescribed this paxil poison in 1998, it made me more suicidal, it should never have been licensed. It also has other awful side effects like aggression, hostility and a severe withdrawal which can take months and sometimes years to recover from. It is disgraceful that GSK knew of these risks yet hid them and sold the drug anyway. Many people have died as a result, I hope this investigation is successful. GSK need to release all the Paxil data to the public domain before any more people are harmed by this dangerous, toxic and defective medication.

Comments for this article are closed.

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