The antidepressant Cymbalta (duloxetine) carries a “Black Box” warning about the risk of suicidal thoughts and actions. The manufacturer, Eli Lilly & Co., has been sued for failing to report suicides during clinical trials before the FDA ordered the boxed warning.
FDA Orders “Black Box” Warning for Cymbalta Suicide Risk
In October 2004, the FDA ordered a “Black Box” warning label about suicidal thoughts and behavior from all antidepressant medications, including Cymbalta.
In 2007, a comprehensive FDA review found no completed suicides occurred among nearly 2,200 children on SSRI antidepressants, but 4% experienced suicidal thoughts or behavior, including suicide attempts — twice the rate of patients on a placebo.
In May 2007, the FDA asked drug-makers to update the boxed warning to emphasize even higher rates of suicide in young adults (ages 18-24 years) during the first 1-2 months of treatment.
Eli Lilly Settles Cymbalta Suicide Lawsuit
In August 2012, the 8th Circuit Court of Appeals ruled that a lawsuit involving the suicide of a 16 year-old boy on Cymbalta could move forward against Eli Lilly.
Dr. Richard Briggs, a family physician, diagnosed Paul Schilf with depression and gave the teenager samples of Cymbalta in 2004. He believed Cymbalta had less risk of suicide than Prozac because he was told “[n]o completed suicides occurred during the clinical trials.”
In reality, five people committed suicides in Lilly-sponsored clinical trials of Cymbalta. After taking Cymbalta for only four weeks, Paul Schilf shot himself on Christmas Eve in 2004. One month later, Lilly updated the label to include the FDA-approved boxed warning.
Eli Lilly agreed to an undisclosed settlement with the Schilf family one month before the lawsuit was set for trial. The case is Schilf v. Eli Lilly Company (Case No. 11-2082).
Antidepressants and Suicide
Depression is a serious mental illness that can lead to suicidal behavior and actions. In 2007, suicide was the third-leading cause of death among people aged 15-24.
Antidepressants can help treat depression, but may increase the risk of suicide. Unfortunately, patients who take selective serotonin reuptake inhibitor (SSRI) antidepressants may experience aggressive or violent behavior, mania, agitation, and extreme restlessness — all risk-factors for self-harm and suicide.
Warning Signs of Suicide
- Talking about feeling hopeless, trapped, being a burden, unbearable pain, or wanting to die
- Extreme mood swings
- Reckless behavior, anxiety, agitation, rage
- Losing interest in things that one cared about
- Withdrawing from activities, isolation from friends and family
- Increased use of alcohol or drugs
- Looking for a way to kill themselves (searching online or buying a gun)
- Giving away possessions
- Sleeping too little or too much
- And more