FDA Drug Safety Communication - No Increased Risk of Prostate Cancer with Parkinson's Disease Medicines containing Entacapone

Published: 08/13/2019

  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

A U.S. Food and Drug Administration (FDA) review of additional data has found no increased risk of prostate cancer with the use of entacapone to treat Parkinson’s disease. The FDA conducted this review after an earlier trial suggested this possible risk. As a result of the new, additional data, FDA recommendations for using Comtan (entacapone) and Stalevo (a combination of entacapone, carbidopa, and levodopa) will remain the same in the prescribing information.


In March 2010, the

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