November 12, 2014 — A federal judge in New York has granted Eli Lilly & Co. summary judgment, ruling against a plaintiff who claimed the drug-maker failed to warn about the withdrawal risks of Cymbalta.
According to Law360, the decision could potentially hurt plaintiff’s chances to consolidate dozens of similar lawsuits in federal court.
U.S. District Judge Robert W. Sweet stated that the label was “accurate, clear and consistent on its face” and “portrays with sufficient intensity the risk involved in taking the drug.” He decided that the plaintiff’s doctor knew about the risks of withdrawal from Cymbalta because more than half of her patients experienced some of the listed symptoms.
The label on Cymbalta includes a list of symptoms, including warnings that symptoms may be severe and negative side effects were significantly more prevalent in Cymbalta patients than those on a placebo.
Lawsuits claim the label is deficient because it does not include adequate warnings about severe withdrawal. Furthermore, it does not provide recommendations for reducing the risk of this side effect, such as tapering off the dosage.
The Prescribing Information states that “greater than or equal to 1%” of patients experience withdrawal, but studies have found that about 44-50% of patients on Cymbalta experience withdrawal symptoms, with 10% classified as “severe.” These studies also found that over half of patients did not improve within 1-2 weeks after discontinuing Cymbalta.
Many patients report “brain zaps” described as a sudden electric-like shock in the brain, often accompanied by dizziness and disorientation. Other symptoms include tingling, burning, itching, psychiatric problems, crying, irritability, changes in appetite, tremors, nausea, and more.