November 12, 2014 — Eli Lilly & Co. has been awarded summary judgement in a lawsuit involving Cymbalta (duloxetine), ruling that the drug-maker adequately warned about the risk of severe withdrawal symptoms.
The decision could diminish the chances of federal judges consolidating dozens of similar lawsuits in a federal Multi-District Litigation (MDL), according to Law360.com.
The plaintiff, Jesse McDowell, claimed that the Prescribing Information on Cymbalta was deficient because it only warned that “greater than or equal to 1%” of patients experience withdrawal.
Studies have found that half of patients experience withdrawal, 10% of cases are severe, and at least 54% of patients do not improve after a few weeks. Although gradually tapering off the dosage could potentially mitigate symptoms, the label does not include recommendations for safely discontinuing Cymbalta.
However, U.S. District Judge Robert W. Sweet decided that the label was “accurate, clear and consistent on its face” and “portrays with sufficient intensity the risk involved in taking the drug.”
He said the label included a list of withdrawal symptoms and warned that some might be severe, and stated that some side effects were significantly more likely from Cymbalta than a placebo.
He also found that McDowell’s doctor was adequately informed about the risk because she said more than half of her patients reported withdrawal symptoms after discontinuing Cymbalta.
One of the most unusual but consistently-reported withdrawal symptoms is a brain zap, described as a sudden electric-like shock through the brain. It may be a form of paresthesia (abnormal tingling, burning, itching, etc.). Other symptoms include psychiatric problems, crying, irritability, changes in appetite, tremors, nausea, and more.