A recent analysis of trial data is said to have shown that Paxil increases the risk of suicide in young adults with major depressive disorder compared to placebo.
The labeling for Paxil already contained a black box warning of the potential for an increase in suicidal thoughts and behavior in children and adolescents taking the drug, however it was not known until now whether or not the drug also increased the risk in adult patients.
The analysis of data showed that 11 of 3,455 patients taking the drug attempted to commit suicide with eight of these attempted suicides in patients under 30 years old.
In the light of the findings, the labeling for the drug has been changed and doctors have been urged by the company and the FDA to closely monitor patients taking the drug.
Although the company was keen to inform doctors of the new analysis, it pointed out that it “is difficult to conclude a causal relationship” between the drug and suicidal behavior due to the small incidence of events and the fact that suicidal behavior is itself a symptom of major depressive disorder.