Cymbalta (duloxetine) is an antidepressant that has a “Boxed Warning” label about the risk of suicidal thoughts and behavior, especially for adolescents initiating treatment. Eli Lilly & Co., the manufacturer of Cymbalta, is facing lawsuits for downplaying the risk by failing to report five suicides that occurred during clinical trials.
FDA Warning for Cymbalta Suicide Risk
In October 2004, the FDA ordered drug-makers to update the label on all antidepressants to add a “Black Box” warning about the risk of suicidal thinking, feeling, and behavior in children and adolescents. The agency also recommended closely monitoring patients starting treatment.
The FDA conducted a comprehensive review involving 372 clinical trials involving nearly 100,000 participants. The rate of suicidal thinking or behavior was 4% for patients on antidepressants, compared to 2% of patients on a placebo. None of the suicide attempts were fatal.
In May 2007, the FDA proposed that drug-makers of all antidepressant medications update the existing boxed warning to emphasize the risk of suicide among young adults aged 18-24 years old during initial treatment (generally the first 1-2 months).
Cymbalta Suicide Lawsuit Settlement
Eli Lilly & Co. has avoided most lawsuits involving suicides associated with Cymbalta. However, in August 2012, the 8th Circuit Court of Appeals ruled that a lawsuit filed on behalf of a 16 year-old boy who shot himself on Christmas Eve in 2004 could proceed.
The victim, Paul Schilf, was diagnosed with depression and given samples of Cymbalta by his family physician, Dr. Richard Briggs. The samples and the website for Cymbalta had no warnings about suicide.
Dr. Briggs testified that he thought the risk of suicide from Cymbalta was lower than Proza. He says he was also told “[n]o completed suicides occurred during the clinical trials.”
The truth was that five people committed suicide during a clinical trial of Cymbalta sponsored by Eli Lilly. One month after Schilf died, Lilly updated the label to include the “Black Box” warning ordered by the FDA. An undisclosed settlement was approved in April 2013, just weeks before the case was set for trial.
The case is Schilf v. Eli Lilly Company (Case No. 11-2082).
SSRI Antidepressants and Suicidal Behavior
Major depressive disorder (MDD) is a serious medical illness that can make it impossible to lead a normal life. Even the most severe cases can be treated, but unfortunately, medications can have serious side effects.
Some patients who start taking selective serotonin reuptake inhibitor (SSRI) antidepressants experience anxiety, agitation, restlessness, mana, aggression, violent behavior, and other risk-factors for intentional self-harm. It is important for patients and caregivers to be aware of these side effects.
Recognize the Warning Signs of Suicide
- Thinking about or talking about death
- Talking about deep sadness, unbearable pain, feeling like a burden, helpless, trapped, or worthless
- Withdrawing from friends and family and stopping activities that were once enjoyable
- Reckless behavior, rage, or extreme mood swings
- Sleeping too much or too little
- Using drugs or alcohol
- Investigating how to commit suicide or buying a gun
- Giving away possessions and “tying up loose ends”
- Suddenly switching from being very sad to appearing calm or happy
- And more