FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)
What safety concern is FDA announcing?
The U.S. Food and Drug Administration (FDA) is warning that results from a clinical trial show a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a chronic blood cancer called leukemia and a lymphoma, a cancer found in the lymph nodes. The trial also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood.