A summary of concerns about Paxil related suicides and suicide attempts

A summary of concerns regarding Paxil.  GSK's analysis found a "higher frequency of suicidal behavior in young adults."

A Summary of Concerns Regarding Paxil

May 11, 2006

GlaxoSmithKline (GSK), the maker of the antidepressant Paxil, has amended its labeling for Paxil to include a warning that, like children and adolescents, adults are at a higher risk of suicidality when taking Paxil. GSK also issued a letter to doctors in the United States alerting them to the new label.

The new warning comes following an analysis GSK conducted based in large part on data collected for the FDA's currently-underway adult analysis of all antidepressants (in FDA's attempt to determine if the suicidality risk found in children and adolescents extends to adults). GSK apparently decided to do its own analysis of the data rather than wait for the FDA's conclusions.

Baum Hedlund lawyer sets the record straight about “new working paper” on antidepressants and teen suicide and responds to Reason Magazine’s recycled and unwarranted conclusions about the rise in teen suicides, declining grades, etc., by pharma-funded academics which have been debunked by other scientists and by the authors themselves.

GSK's analysis found a "higher frequency of suicidal behavior in young adults" ages 18-24 for all indications and "adults with MDD [Major Depressive Disorder] (all ages), the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo. [ ] This difference was statistically significant." Despite GSK's admission of higher rates of suicidality and "statistical significance" (which generally means fairly conclusive proof of causation), in its letter and other briefing
material, GSK attempts to downplay the risk and suggests that its awareness of the risk is "new."