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INDIANAPOLIS - Eli Lilly and Co. said Friday that it will lengthen the withdrawal period used to wean participants in a drug study off an experimental medication after the suicide of a 19-year-old woman taking part in the tests.
Lilly required mental health evaluations of test subjects after the Feb. 7 suicide of Indiana college student Traci Johnson. Some participants complained of sleeplessness, anxiety or nervousness during their withdrawal from duloxetine, a drug Lilly is testing for two uses: depression and stress urinary incontinence. But the company has said none reported symptoms that suggested a suicide risk.
Indianapolis-based Lilly has now doubled the tapering period for the drug to eight days.
"We did find people who were uncomfortable," said John Hayes, a clinical psychiatrist who leads Lilly's development team for duloxetine. "We were also addressing peace of mind and taking the most conservative approach."
Hayes said there is no evidence that longer tapering periods make people more comfortable, but the change seemed "reasonable and prudent."
"We didn't have anyone who said, "Thank God you're going to take a longer time to taper it,"' he said. "Many of the subjects felt fine in the study."
The U.S. Food and Drug Administration is reviewing Johnson's death. A coroner's report released this week did not cite the drug as a factor in her suicide.
Lilly has said it does not believe the drug led to the suicide, but critics say people going off antidepressants often have a higher risk of suicide.