August 12, 2004 INDIANAPOLIS (AP) -- The Food and Drug Administration has concluded that Eli Lilly and Co.'s newly approved antidepressant Cymbalta did not trigger the suicide of a woman from Bensalem, Pa., who was taking part in a clinical trial.
An FDA investigation found that Cymbalta could not be linked to the death of Traci Johnson, who hanged herself with a scarf in Lilly's Indianapolis drug-testing clinic.
Johnson, a 19-year-old former Indiana Bible College student, killed herself Feb. 7 as she was participating in a study to see how high doses of the drug affected healthy volunteers.
A memo about the closing of the FDA investigation of the suicide is part of the FDA's Cymbalta approval package, the first part of which was sent to Lilly last week, an FDA spokesman said. It gives the drugmaker permission to start selling Cymbalta.
The FDA declined to immediately release any written documents related to its investigation.
Lilly has not yet received the memo, but the company was told by the FDA that it had no further questions about the suicide, Lilly spokesman David Shaffer said.
"We were informed there would be no findings" contrary to what Lilly had concluded about the suicide, he said. Lilly has said it found its drug was not to blame.
The Marion County coroner ruled Johnson's death was by hanging.
Johnson had stopped taking the drug and was being weaned from it when she killed herself. She took doses up to six times the recommended 60 mg daily dose for depressed patients.
Lilly later increased from four days to eight the weaning period in the drug trial.
The drugmaker has said Johnson was healthy and not depressed.
Johnson's suicide came amid debate over the link between some antidepressants and suicide in users, particularly children.
In March, the FDA told 10 drugmakers to strengthen suicide-related warnings on labels for antidepressant drugs. Two FDA advisory committees are currently examining any links between antidepressants and suicides in children.
Copyright 2004 The Associated Press. All rights reserved.
