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Cymbalta Suicide Data Withheld by FDA

Apr 16, 2008 | Parker Waichman LLP Cymbalta, an antidepressant made by Eli Lilly, has been linked to suicides.  Although suicide is sometimes the tragic outcome of depression, some of those who have committed suicide while taking Cymbalta were not being treated for depression - or for any other mental illness.  Unfortunately, despite reports of suicides not linked to depression, the Food & Drug Administration (FDA) has been slow to act on Cymbalta, and has actually concealed information on some suicides that occurred during clinical trials conducted by Eli Lilly, the drug's maker.  

Cymbalta - known generically as Duloxetine - was approved by the FDA in 2004 to treat depression and peripheral neuropathy.  By the end of that year, Cymbalta sales topped $61.3 million. At some point—the date is undisclosed—Eli Lilly began testing Duloxetine under the brand name Yentreve as a treatment for urinary incontinence.  In 2004, Traci Johnson, a healthy 19-year-old college student volunteer enrolled in a Cymbalta/Yentreve trial hung herself by a scarf from a shower rod in Lilly's Indianapolis, IN laboratory while withdrawing from the drug.  Johnson had not been diagnosed with depression, and had been screened for mental health issues prior to being accepted into the trial.  

Eli Lilly has claimed that Johnson's tragic death was an isolated incident. Still, the FDA ordered Eli Lilly to stop accepting new volunteers for the study and to have continuing participants evaluated by an independent psychiatrist and sign new consent forms. But in another Cymbalta trial of 4,124 depressed patients just weeks later, four more participants committed suicide.  In 2005, Eli Lilly stopped seeking approval for Yentreve in the US. The company did not say why the drug was not approved, nor was it required to do so by the FDA.

The publicity surrounding the Johnson suicide raised concerns among researchers and physicians about Cymbalta's safety. Some went to the FDA looking for answers, but the agency was silent.  The FDA said that the data from the clinical trials in question represented a "trade secret" that could not be released as Yentreve was never approved. This might be a perfectly acceptable reason for drug not on the market, but Eli Lilly was conducting these clinical trials to gain approval for new uses of Duloxetine.  Meanwhile, millions of people were already taking it as Cymbalta, and had no idea it had been associated with these suicides. Unfortunately, the FDA didn't seem concerned that it might be protecting so-called trade secrets at the expense of patient safety.

Cymbalta - under the name Yentreve - was already being sold as a urinary incontinence treatment overseas, where a disturbing pattern of suicides emerged.  According to overseas data, twice the expected number of suicide attempts among middle aged women were seen with the drug-- 400 per 100,000 person-years versus a baseline of 160 per 100,000 person-years.   Other sources also recorded disturbing incidents of Cymbalta suicides.  

By presenting the FDA with a Freedom of Information Act request on behalf of "Independent on Sunday," reporter Jeanne Lenzer learned of 41 deaths and 13 suicides associated with Cymbalta, which did not include Johnson's or the four suicides that followed.  The data obtained by Lenzer didn't include the other suicides because those clinical trials fell under the FDA's trade secret rationalization.

Antidepressants like Cymbalta have been linked to hundreds of suicides.  In most cases, drug makers blame those incidents on the depression itself.  But the Cymbalta suicides indicates there is more to the story. Unfortunately, because the FDA has insisted on protecting Eli Lilly, the whole story might never be known.

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