Stalevo Prostate Cancer Concerns Spark FDA Review

Federal drug reviewers say they have concerns that the side effects of Stalevo, a Parkinson’s disease medication by Novartis, may increase the risk of prostate cancer. 

The FDA announced on Wednesday that it has begun a safety review of Stalevo and its potential link to prostate cancer after data from a long-term clinical trial resulted in an unusual number of men developing the disease. The safety review does not mean that the FDA has concluded that there is a causal connection between Stalevo and prostate cancer; only that such a possible link is under investigation.

Stalevo (entacapone/carbidopa/levodopa) is a prescription drug used to treat dyskinesia (movement disorder) associated with the onset of Parkinson’s disease. The drug was approved by FDA in June 2003.

Concerns about Stalevo side effects arose during a 4-year clinical trial called Stalevo Reduction in Dyskinesia Evaluation – Parkinson’s Disease (STRIDE-PD). Researchers looked at 745 patients at 77 centers in 14 countries in a double blind, randomized clinical trial that included 31 sites in the U.S. During the study, 245 men received Stalevo for 2.6 to 4 years. Researchers found that 9 of those men (3.7%) developed prostate cancer, while less than 1% of men not given Stalevo developed prostate cancer during the same time period.

The FDA notes that other trials did not find evidence of a prostate cancer link; however side effects from long-term exposure had never been conducted until the STRIDE-PD trials.

Currently, the FDA is recommending that patients taking Stalevo should continue to do so. The agency is still reviewing the information and will make more information available as it develops during the safety review. The FDA warned healthcare professionals to be aware of the possible Stalevo prostate cancer risk and urged them to follow current guidelines for prostate cancer screening.