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FDA Safety Update on Risk of Prostate Cancer and Treatment for Parkinson’s Disease

By: Sarah Jackson
Posted: Tuesday, August 20, 2019

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. The FDA conducted this review after an earlier trial published in the Annals of Neurology suggested a possible risk. As a result, FDA recommendations for using entacapone (Comtan) and a combination of entacapone, carbidopa, and levodopa (Stalevo) will remain the same in the prescribing information.

After a first Safety Announcement released in March 2010, the FDA required the manufacturer (Novartis) to conduct a study to further evaluate this potential risk. The FDA also studied this issue independently using data from the Department of Veterans Affairs health-care system in the STRIDE-PD trial ( identifier NCT00099268). Based on these additional studies, the FDA concluded that use of entacapone 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. They have been approved and on the market for almost 20 years. The combination of entacapone with carbidopa and levodopa 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.

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