1. Aschenbrenner, Diane S. MS, RN


* The Food and Drug Administration (FDA) has determined that entacapone, used in the management of Parkinson's disease, does not increase the risk of prostate cancer or death from prostate cancer.


* The decision was based on an analysis of data from a postmarketing clinical trial conducted by the drug manufacturer and an FDA review of data from the Department of Veterans Affairs.



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In 2010 the Food and Drug Administration (FDA) alerted health care providers to clinical trial results that possibly linked a drug used to treat Parkinson's disease-entacapone (sold under the trade name Comtan and in combination with carbidopa and levodopa under the trade name Stalevo)-to prostate cancer. Consequently, the FDA required the drug manufacturer to conduct an additional postmarketing trial to assess this possible link. The FDA also independently reviewed data from the Department of Veterans Affairs. After a review of these findings, the FDA has concluded that there is no increased risk of prostate cancer in patients receiving entacapone.


The clinical trial conducted by the drug manufacturer included 11,396 Finnish men with Parkinson's disease, 1,141 of whom received entacapone. Patients were followed for an average of 4.7 years. The study found no increased risk of prostate cancer or prostate cancer death in patients receiving entacapone, including those who received entacapone long term (more than 360 days' cumulative treatment).


In addition, the FDA and Veterans Affairs Center for Medication Safety conducted a retrospective cohort study of 17,666 U.S. male veterans with Parkinson's disease. Mean follow-up was 3.1 years for those who received entacapone and 4 years for those in the control cohorts. Again, no difference in risk of prostate cancer was found.


Nurses and NPs should ensure that patients receiving entacapone (Comtan or Stalevo) are screened for prostate cancer based on current screening recommendations.


To read the FDA Drug Safety Communication for entacapone, go to