Entacapone use not associated with increased risk of prostate cancer, confirms FDA

The U.S Food and Drug Administration (FDA) has recently made a safety announcement regarding a commonly used medication for Parkinson's disease, Entacapone. The apex food and drug regulatory body have confirmed that entacapone use is not associated with increased risk of prostate cancer.

In March 2010, the Food and Drug Administration made an announcement warning the public about a possible risk of prostate cancer with the entacapone component of Stalevo, based on the results of an earlier trial. 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. Based on these additional studies, the FDA concluded that entacapone use is not associated with an increased risk of prostate cancer.

The recent review of the trial the Food and Drug Administration 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 Comtan (entacapone) and Stalevo (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 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.

Recommendations for health professionals and patients

Health care professionals should follow standard prostate cancer screening recommendations for patients.

Patient and caregivers should continue to take your medicine as prescribed. Talk to your health care professionals if you have any questions or concerns.