Entacapone use not linked to higher risk of prostate cancer: USFDA

October 8, 2019 0 By FM

Entacapone, the commonly used medication for Parkinson’s disease is not associated with increased risk of prostate cancer, said USFDA, confirming the safety of the drug in a recent announcement.

In March 2010, the FDA warned the public about a possible risk of prostate cancer with the entacapone component of the product Stalevo, based on the results of an earlier trial. Stalevo is a combination of entacapone, carbidopa, and levodopa.

Subsequently, the FDA demanded the Stalevo manufacturer, Novartis, to conduct a study to further evaluate this potential risk.

After studying this issue independently using data from the Department of Veterans Affairs health care system, the FDA concluded that entacapone use is not associated with an increased risk of prostate cancer.

The recent review of the trial by the agency has ruled out the risk of prostate cancer associated with the use of medicines containing entacapone.

As a result, the FDA recommends the use of entacapone and a combination of entacapone, carbidopa, and levodopa to remain the same in the prescribing information.

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 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.