Paxil Attorneys

In 1999 GlaxoSmithKline PLC applied to the FDA for approval of its drug Paxil. However, new questions have risen as to if Glaxo deliberately misrepresented data on suicide risk for its antidepressant when it applied for approval from the FDA.

A study by a Harvard psychiatry instructor, 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.

Glaxo’s counting lessened the variation between suicidality rates in the Paxil and placebo groups, according to the report. The company counted placebo patients who had attempted or committed suicide before the study formally started, which enhanced the results for Paxil.In 2004, the FDA called for added warnings on popular antidepressants known as selective serotonin-reuptake inhibitors, or SSRIs, about potential links to suicidal behavior. In 2006, Glaxo sent a letter to doctors stating that its studies showed that the risk of suicidality in depressed adults was 6.7 times as high in patients taking Paxil as in those taking a placebo.

• Sen. Grassley’s letter to the FDA and the Glenmullen Report on Paxil

Sen. Chuck Grassley, an Iowa Republican, released Dr. Glenmullen’s study and a letter to the FDA, asking it to investigate the original approval process for Paxil and Glaxo’s application in light of Dr. Glenmullen’s report. A Glaxo spokesperson emailed a company statement that was originally issued Feb. 6, when an earlier version of Dr. Glenmullen’s report was first unsealed by a court. That version was missing nine pages that included information on Glaxo’s counting methods. GlaxoSmithKline has provided the U.S. Food and Drug Administration over the years with numerous reports from its clinical studies,” the statement says. “As soon as GlaxoSmithKline became aware of a potential increased risk in certain populations, it proactively brought it to the attention of FDA and other regulatory bodies.”

SmithKline’s former top executive, Jean-Pierre Garnier, who was Glaxo’s CEO until last month, said in a 2006 deposition in a lawsuit that the original data given to the FDA shouldn’t have included some of the placebo patients. In another 2006 court document, Glaxo “admits that five of six ‘attempted suicide’ events” in the placebo group took place before the studies began. During the 1991 meeting, members of the FDA’s advisory committee repeatedly said they wished there were more data to review on suicidality, but, the report said, “unbeknownst to the committee, the data already existed.”

It is clear that there have been problems with Paxil from the beginning. At Napoli Bern Ripka we are here to address all of your concerns regarding Paxil. This is just an example of another large drug company focusing on money rather than the safety of their drugs. If you or a loved one has taken Paxil while pregnant causing birth side effects, please contact Napoli Bern Ripka so that we can assess your case as you may have a valuable legal claim.

For more information about this article in the Wall Street Journal click here