There are approximately 250 pending lawsuits against drug manufacturer Eli Lilly over its wonder-child, Cymbalta. Plaintiffs claim that the withdrawal symptoms experienced occur much more frequently than the Big Pharma giant warns. The first case went to trial this month and Big Pharma wins the first Cymbalta withdrawal suit.
The drug, which brings Lilly about $3.9B in annual sales, includes a label warning that 1% or more patients who stop taking Cymbalta could experience withdrawal symptoms such as irritability, nausea, insomnia, seizures and sensory disturbances. Plaintiffs claim that the rate of occurrence is much higher, as much as 44% of patients, according to a 2005 study by the Journal of Affective Disorders.
Cymbalta is an extremely popular drug from the antidepressant class of serotonin and norepinephrine reuptake inhibitors (SNRIs). It was given FDA approval in 2004 for treating major depressive disorder. The FDA later expanded Cymbalta’s approval to include treating generalized anxiety disorder and fibromyalgia.
Claudia Herrera filed this first suit in federal court. There are three other cases involving Cymbalta withdrawal symptoms on the docket for this month. Herrera’s claim states that Lilly downplayed the potential for withdrawal symptoms on the warning label. Herrera took Cymbalta from 2006 to 2012 for anxiety.
Her doctor gradually weaned her off the drug and she began experiencing Cymbalta withdrawal symptoms. These included spasms, suicidal thoughts, anxiety and the “sensory disturbances” mentioned earlier. These disturbances typically take the form of Cymbalta “zaps,” strong feelings of being shocked with electricity.
Lilly stood by its warnings in its response to Herrera’s suit, saying the warnings were sufficient and that Herrera’s doctor knew of the potential risks.
Apparently, this was enough to satisfy the jury. The trial began on Tuesday and the jury returned a verdict in favor of Eli Lily on Friday.
Celeste Stanley, an Eli Lilly spokesperson, said, “While Lilly is sympathetic to Ms. Herrera’s conditions, we are pleased with the jury’s verdict.” As well they should be, with three more trials scheduled this month. They may have the same good fortune Pfizer has been experiencing in its Zoloft birth defect cases.