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FDA review finds no increased risk of prostate cancer with Parkinson's disease medicines containing entacapone (Comtan, Stalevo)

FDA Drug Safety Podcast


Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin Advanced Practice Nurse.

On August 13, 2019 FDA announced that a review of additional data found no increased risk of prostate cancer with the use of entacapone to treat Parkinson’s disease. We conducted this review after an earlier trial suggested this possible risk. As a result, our recommendations for using Comtan (active ingredient entacapone) and Stalevo (a combination of active ingredients entacapone, carbidopa, and levodopa) will remain the same in the prescribing information.

This is an update to the FDA Drug Safety Communication: Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and Possible Development of Prostate Cancer issued on March 31, 2010 when we alerted the public that we were aware of a clinical trial suggesting a possible increased risk of prostate cancer with the entacapone component of Stalevo. We subsequently required the Stalevo manufacturer, Novartis, to conduct a study to further evaluate this potential risk. We also studied this issue independently using data from the Department of Veterans Affairs health care system. Based on these additional studies, we 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.

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

Patients should continue to take their medicine as prescribed and talk to their health care professionals if they have any questions or concerns.

To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving entacapone-containing products or other medicines to the FDA MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary with references can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

And follow us on Twitter @FDA_Drug_Info for up to the minute important drug information. Know the moment it happens. Thank you for listening.

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