Paxil And Suicides
In June 2003, the FDA issued a warning to doctors about prescribing Paxil to patients under the age of 18. The agency said that because of the link between Paxil and suicide in younger patients, the drug was too risky to prescribe to them.
Statistics released at the time by GlaxoSmithKline, the drug’s manufacturer, noted that suicide attempts or suicidal thoughts were three times more common among Paxil users than among adolescents who were given a placebo.
GSK’s own statistics showed that suicidal attempts or thoughts were three times more common among adolescents using Paxil.
GSK settles in New York
In August 2004, GSK agreed to a $2.5 million settlement in a Paxil lawsuit. According to the deal, the company was required to release the results of all of its Paxil studies and to keep them available for at least 10 years in order to alert patients of the risk of Paxil side effects.
The FDA updated its labeling for Paxil and other selective serotonin reuptake inhibitors (SSRIs) in October 2004, adding a black-box warning to alert doctors of the risk of suicide or suicidal thoughts among adolescents who were prescribed the antidepressants.
Although GSK has denied a link between Paxil and suicide among older patients, recent studies have suggested that the risk of Paxil side effects among patients over 18 may be just as high as with adolescents.
Strong evidence of a Paxil–suicide link
The strongest evidence of the link between Paxil and suicide came in February 2006, when a medical expert’s analysis of GSK’s clinical trial data was released during the course of a Paxil lawsuit. Dr. Peter Breggin uncovered a number of suicides or suicide attempts that had gone unreported in the company’s initial release of the Paxil data.
When he incorporated this new information into the existing results, Dr. Breggin found that the rate of suicidal behavior was 10 times higher with Paxil than with placebo.
In May 2006, the FDA and GSK sent a letter to doctors warning that Paxil could increase the risk of suicide in both young adults and older patients. The letter cited a study conducted by the company which showed that Paxil doubled the risk of suicidal behavior in patients ages 18 to 24.
Several Paxil lawsuits have been filed by the families of former patients who engaged in suicidal or violent behavior after using the drug.
