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 has 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.
GSK’s analysis found a “higher frequency of suicidal behavior in young adults” ages 18-24 for all indications and for “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.”
GSK has finally done the right thing, unfortunately, it is overshadowed by its delay. This analysis could and should have been done a long time ago. GSK has had this data in its possession for years. Unfortunately, it continues to spin the facts as if this is ‘new data.’ People need to realize that GSK limited this analysis to only certain of its clinical trials, which effectively excluded numerous suicide events. We know, for instance, that in GSK’s initial FDA submission in 1989, there were 7 suicides and 42 suicide attempts in Paxil patients, while there were zero suicides and 1 suicide attempt on placebo.
GSK should have warned from the beginning and the FDA should have done a better job at protecting American consumers. This warning, tragically, comes far too late for the families whose loved ones have fallen victim to this deadly side effect.
The Baum Hedlund law firm has been fighting for increased warnings on all SSRIs since the early 1990s, starting with Prozac, and was the first law firm to take on the Paxil drug maker on a national scale in 2001. Baum Hedlund is still litigating dozens of suicide cases against GSK involving adults and children as young as 7-years-old.
GSK has had an FDA ordered black-box warning (the most severe) on its Paxil label directed at children and adolescents concerning the increased risk of suicidality, as do all manufacturers of antidepressant-SSRIs, since 2004.
About Baum Hedlund
Baum Hedlund is one of the leading national law firms representing antidepressant suicide and suicide attempt victims across the country. The firm represents approximately 50 victims, over one-third of those are children and adolescents.
Since 1990, Baum Hedlund has been handling SSRI (selective serotonin reuptake inhibitors) suicide/violence cases and served on the Plaintiffs’ Steering Committee in the first SSRI-suicide litigation involving Prozac (the first SSRI approved by the FDA for marketing in the U.S.).