The FDA posted information on its Web site last night concerning patients who displayed suicidal tendencies during trials of Eli Lilly’s Cymbalta, being tested for stress-related urinary incontinence.
The site said a “higher-than-expected rate of suicide attempts was observed,” in studies following the formal part of the trial.
The FDA posted the information despite objections from Lilly.
“Eli Lilly has questioned our legal authority under the Food, Drug and Cosmetic Act to post some information about drug safety on our Web site,” the FDA’s acting director for the Center for Drug Evaluation and Research, Stephen Galson, said in a Wall Street Journal report.
Lilly withdrew its application to market Cymbalta for urinary incontinence in January.
Cymbalta’s main ingredient duloxetine hydrochloride has been approved as a treatment for the condition in Europe under the brand name Yentreve.
The Cymbalta information was posted as part of a broader FDA warning that adults taking antidepressants should be closely monitored for suicidal tendencies, citing publications that suggest an increased risk among patients taking the drugs.