Trial Against Multi-Billion Dollar Psychotropic Drug Giant Reveals Almost 900% Suicide Increase With Antidepressant Use
A trial is currently underway in Illinois as a widow seeks to hold pharmaceutical manufacturer GlaxoSmithKline accountable for improper labeling and minimizing a potentially serious side effect of a well-known antidepressant.
Paroxetine is a widely prescribed antidepressant and anti-anxiety drug under the class of drugs known as selective serotonin reuptake inhibitors (SSRIs). Paroxetine is most commonly known as the brand name of Paxil, manufactured by GlaxoSmithKline (GSK).
Since 2012, Wendy Dolin has been engaged in a legal battle against GSK following the suicide of her husband, Stewart Dolin. Wendy says that in the summer of 2010, Stewart was prescribed a generic version of Paxil for anxiety issues related to work. According to Wendy, Stewart Dolin complained of becoming increasingly anxious and restless and was unable to sleep while taking the drug. On July 15, 2010, less than one week after beginning this medication, Stewart committed suicide by walking in front of a train. . .
The lawsuit alleges that GSK whitewashed the suicide risks of Paxil in its data given to the FDA. The complaint explains that in 1989, GSK”s “Integrated Summary of Safety Information,” required to gain approval from the FDA, included a presentation identifying the number of suicide and suicide attempts during clinical trials. The suit alleges that GSK’s summary “skewed the statistical analysis of the data presented and obscured the true risk” by including suicide attempts “of placebo patients that had taken place in the placebo run-in (or wash-out) phase” before the clinical trials began. “Run-in” or “wash-out” refers to a time period of removing any other drugs in a trial participant’s system; any “adverse events” that take place during those periods are not appropriate or generally accepted for inclusion in calculations during clinical trials, the suit claims. . .
The trial against GSK is in progress and is expected to last a few weeks. Bob Fiddaman, a blogger and author who has written extensively about his own experiences with paroxetine, has been covering the developments of the trial. Fiddaman wrote that a “startling revelation” was unveiled on March 22nd: “Attorneys representing widow Wendy Dolin showed the ratio of Paxil-induced suicidality in adults is a staggering 8.9. It is not 6.7, as previously claimed and reported by Glaxo. The 6.7 figure is astoundingly high in itself, but the 8.9 ratio is flabbergasting! Plaintiff witness, Dr. David Ross, said this figure is ‘astounding.’ What you should remember here is that GSK’s 1989 drug application for Paxil said the suicidality odds ratio was 2.6.” (For more from the author of “Trial Against Multi-Billion Dollar Psychotropic Drug Giant Reveals Almost 900% Suicide Increase With Antidepressant Use” please click HERE)
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