Posted from: Thursday, September 19, 2019 - 09:42 AM - Present

No Increased Risk of Prostate Cancer with Entacapone Products

August 13, 2019 – The U.S. FDA has released an update on the safety of entacapone-containing products following review of trial data. In March 2010, the agency alerted the public to a potential increased risk of prostate cancer related to the use of entacapone, which is a component of Stalevo® (carbidopa, levodopa, and entacapone) and the sole active pharmaceutical ingredient of Comtan® (entacapone), both manufactured by Novartis.

As a result of its review, the FDA has determined that there is no increased risk of prostate cancer with use of entacapone products. Initial concern came from a trial of Stalevo that was underway in 2010. Following the FDA’s safety notice regarding the drug, Novartis conducted a study to further evaluate the potential risk. In addition, the FDA studied the issue independently using data from the Department of Veterans Affairs.

Both Stalevo and Comtan are indicated to treat Parkinson’s disease. The FDA advises patients and caregivers to continue use of the medication as prescribed, and to contact their healthcare professional with any questions or concerns. Healthcare professionals should follow standard prostate cancer screening recommendations for patients. To report side effects experienced with the use of entacapone-containing products, patients, caregivers, and healthcare providers can reach out to the FDA through its MedWatch program.

A full copy of the safety update is available on the FDA’s website.

Last Updated Friday, October 18, 2019 - 12:30 AM.