September 19, 2014 — Law360 reports that Eli Lilly & Co. has asked federal judges in New York to dismiss a lawsuit alleging that the company failed to adequately warn about the risk of severe withdrawal from Cymbalta (duloxetine), an antidepressant.
The plaintiff, Jesse McDowell, filed the lawsuit (PDF) in the U.S. District Court for the Southern District of New York in June 2013.
McDowell started taking Cymbalta in 2009 to treat depression and anxiety. Around March 2012, he was still experiencing severe anxiety and depression. His doctor recommended tapering his dose of Cymbalta over a seven-month period.
When he stopped taking Cymbalta, he experienced severe withdrawal symptoms. For example, “brain zaps” left him disoriented and confused. He also suffered from frequent suicidal thoughts, bouts of insomnia, and debilitating headaches. He continues to suffer from persistent symptoms of withdrawal, including severe headaches.
He also continues to suffer from “brain zaps,” which are reported by many people who discontinue Cymbalta. The side effect is described as a sudden, electric-like shock in the brain that is often accompanied by dizziness.
Eli Lilly & Co. is currently facing at least 28 lawsuits from people who experienced severe withdrawal. Plaintiffs are asking federal judges to consider consolidating the cases in a federal Multi-District Litigation (MDL).
Members of the litigation alleges that Eli Lilly & Co. misled patients and their doctors about the risk of withdrawal. Lilly’s own clinical trials demonstrated that 44-50% of patients experienced withdrawal, 10% of cases were severe, and 54% of cases did not resolve after 1-2 weeks.
Patients in the trial took Cymbalta for only 8-9 weeks before discontinuing it. The Prescribing Information warns only that withdrawal occurs in “greater than or equal to 1%” of patients, and it includes no warnings about severe symptoms or a protocol for tapering the dose.