No Higher Prostate Cancer Risk with Entacapone

FDA says its review of additional data found no increased risk of prostate cancer with the use of entacapone (Orion’s Comtan and Stalevo) to treat Parkinson’s disease. An 8/13 drug safety communication, updating a 3/31/10 communication, says the agency’s recommendations for using Comtan (entacapone) and Stalevo (entacapone, carbidopa, and levodopa) will remain the same in the prescribing information.

The 2010 notice said the agency was aware of a clinical trial suggesting a possible increased risk of prostate cancer with the entacapone component of Stalevo. It then asked Novartis (formerly the Stalevo applicant) to conduct a study to further evaluate the potential risk. FDA says it also studied the risk independently using Department of Veterans Affairs data.

“Based on these additional studies, we concluded that entacapone use is not associated with an increased risk of prostate cancer,” the communication says.