FDA Drug Safety Communication

FDA is evaluating clinical trial data that may suggest that patients taking Stalevo, a Parkinson's disease medication, may be at an increased risk for developing prostate cancer. In this trial, patients taking Stalevo, which contains a combination of the active ingredients entacapone, carbidopa, and Levodopa, were compared to those taking carbidopa and levodopa (sold as Sinemet), a combination medication also used to treat Parkinson's disease. Entacapone is available as a single-ingredient product sold under the brand name Comtan and it is also used to treat symptoms of Parkinson's disease.

At this time, FDA's review of Stalevo is ongoing and no new conclusions or recommendations about the use of this drug have been made.

Healthcare professionals should be aware of this possible risk, follow the recommendations in the drug label when prescribing Stalevo or Comtan, and continue to monitor patients for the development of prostate cancer as recommended by the current prostate cancer screening guidelines.

This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. The agency will update the public as soon as this review is complete.

View the full FDA Drug Safety Communication on FDA.gov