Lilly Withdraws Duloxetine Application from FDA

Lilly Withdraws Duloxetine Application from FDA

Fri, 28 Jan 2005

Eli Lilly and Boeringer Ingelheim have jointly announced that they have recinded their U.S. FDA Application for Duloxetine for Treatment of Stress Urinary Incontinence. http://newsroom.lilly.com/ReleaseDetail.cfm?ReleaseID=154081&print=yes

Withdrawal of an application from FDA approval process is usually the result of the manufacturer’s failure to demonstrate in clinical trials that the drug’s risk-benefit ratio is positive. In other words, the risks outweigh the benefit. Duloxetine was approved by the FDA for the treatment of depression in August 2004 (marketed as Cymbalta in the US). The label has a Black Box warning about the drug causing and increased risk of suicidality.

In clinical trials involving 4,124 people who tested duloxetine, (according to David Shaffer, a Lilly spokesman) there were 7 suicides; 6 by subjects on duloxetine – including the suicide of a healthy 19-year old volunteer Bible student, Traci Johnson who committed suicide by hanging in Lilly’s laboratory on February 7, 2004. Of the 7 people who committed suicide during duloxetine clinical trials, one was on placebo, another had taken a drug other than duloxetine during the trial, four were depressed.

Just prior ot its approval of Cymbalta for depression, in August 2004, the FDA announced that the agency was closing its investigation of Traci Johnson’s suicide. To our knowledge, the FDA has never made its report of that investigation public.

The FDA-approved Cymbalta label (Aug. 3, 2004) warns:

“families and caregivers of patients being treated with antidperessants for major depressive disorders or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, and [ ] other symptoms, as well as the emergence of suicidality.”

Traci was judged not suicidal or depressed by Lilly physicians when she entered the trial as a control subject in a duloxetine trial for incontinence. As a subject in Lilly’s own laboratory, Traci was most likely closely monitored, but that did not protect her.

Contact: Vera Hassner Sharav
212-595-8974