A U.S. Food and Drug Administration (FDA) review of additional data found no increased risk of prostate cancer with the use of entacapone to treat Parkinson’s disease. FDA conducted this review after an earlier trial 1 suggested this possible risk. As a result, FDA’s recommendations for using Comtan (entacapone) and Stalevo (a combination of entacapone, carbidopa, and levodopa) will remain the same in the prescribing information.
FDA alerted the public in March 2010 that FDA were aware of a clinical trial1 suggesting a possible increased risk of prostate cancer with the entacapone component of Stalevo. Agency subsequently required the Stalevo manufacturer, Novartis, to conduct a study 2 to further evaluate this potential risk. Agency also studied this issue independently using data from the Department of Veterans Affairs health care system. Based on these additional studies, FDA concluded that entacapone use is not associated with an increased risk of prostate cancer.
Medicines that contain entacapone with carbidopa and levodopa have been shown to effectively treat symptoms of Parkinson’s disease such as muscle stiffness, tremors, spasms, and poor muscle control. These medicines have been approved and on the market for almost 20 years. The combination of entacapone with carbidopa and levodopa in Stalevo has been shown to reduce end-of-dose “wearing-off” in patients with Parkinson’s disease to a greater degree than with entacapone alone or with the two-drug combination of carbidopa and levodopa.