Paxil Probe Said to Be GrowingJun 20, 2008 | Parker Waichman LLP
An investigation into the antidepressant Paxil appears to be getting bigger. According to The Wall Street Journal, GlaxoSmithKline has confirmed that a previously disclosed Colorado-based Justice Department investigation of marketing practices now also includes the Boston U.S. attorney's office and is being coordinated by the agency in Washington.
Paxil - known generically as paroxetine - was brought to market by GlaxoSmithKline in 1992, and by 2006, Paxil was the fifth most-commonly prescribed antidepressant in the US, with more than 19.7 million prescriptions.
In September 2004, the Food & Drug Administration (FDA) issued a warning for Paxil, stating that the drug can cause suicide and violence in children and teenagers. The warning followed a report issued by Britain’s Department of Health which said that evidence provided by the drug company from nine studies based on more than 1,000 youngsters shows there is an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil.
On May 12, 2006, the FDA issued another Paxil suicide warning when results of another study showed that Paxil increased suicide risk in young adults aged 18-30. An analysis of multiple trials including 15,000 patients revealed 11 attempted suicides among Paxil users and only 1 attempted suicide among those taking the placebo. Of the 11 suicide attempts in Paxil users, 8 were in people aged 18 to 30.
According to The Wall Street Journal, at a meeting in Boston last year, lawyers representing families suing Glaxo were asked about information, documents and depositions concerning Paxil's potential link to suicidal behavior in adolescents and adults, and how the company portrayed that risk to doctors and to the FDA.
According to some who attended the meeting, the Justice Department was particularly interested in documents disputing research conclusions that Glaxo submitted to the FDA on suicidality. Investigators asked many questions related to a controversial 2001 study paid for by Glaxo that has become known as Study 329. That study supposedly showed Paxil was safe for teens and children. Study 329 has come under fire from several independent medical researchers. The prosecutor and FBI "were quite interested in how Study 329 was used to promote Paxil for teenagers and kids by clinical researchers Glaxo had underwritten," a plaintiffs' lawyer who attended the meeting told The Wall Street Journal.
News of the expanded Paxil probe comes just months after British authorities concluded a four-year investigation into whether Glaxo failed to inform drug regulators in that country about a link between Paxil and suicidal behavior in children and teens in a timely matter. Criminal charges were not pursued in that case because British laws are unclear on whether companies are obligated to report certain drug data.
Last week, Sen. Charles Grassley (R-Iowa) has also asked the FDA to probe whether Glaxo knew of Paxil’s suicide risk when it first sought approval for the drug. In his letter to the agency, Grassley cited the British investigation.