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Thursday, 19 June 2008
Did GlaxoSmithKline Mislead the FDA on Paxil Risks?

"GlaxoSmithKline PLC faces new questions about whether it deliberately misrepresented data on suicide risk for its antidepressant Paxil when it applied for the drug's approval to the U.S. Food and Drug Administration at an advisory committee meeting in 1991, a charge the company has denied.

A study by a Harvard psychiatry instructor, underwritten by plaintiffs' lawyers and previously kept under seal by a court order, says that Glaxo 'improperly' counted patients taking placebos during clinical studies. From 1989 through 1991, Glaxo then submitted information to the FDA that indicated no major difference in risk of suicidal behavior, or suicidality, as doctors call it, between patients who took Paxil and those who took a placebo. However, Glaxo's counting minimized the differences between suicidality rates in the Paxil and placebo groups, according to the report. For instance, the company counted placebo patients who had attempted or committed suicide before the study formally started, which enhanced the results for Paxil."

June 19, 2008

POSTED BY: DW AT 02:53 pm   |  Permalink   |  E-mail this
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Paxil (Paroxetine) is also available as Paxil CR, Pexeva, and generic paroxetine hydrochloride. Paxil is manufactured by GlaxoSmithKline. Willis Law Firm represents clients in drug lawsuits and mass tort nationwide, including Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin and Wyoming.

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