The U.S. Food and Drug Administration (FDA) has notified healthcare professionals that it is reviewing clinical trial data which suggests that patients with Parkinson’s disease who are being treated with a combination Parkinson’s medication may be at an increased risk for prostate cancer.

Stalevo, a combination of three drugs – entacapone, carbidopa and levodopa, is used in the treatment of Parkinson’s disease. In a clinical trial called Stalevo Reduction in Dyskinesia Evaluation – Parkinson’s Disease (STRIDE-PD), patients with Parkinson’s disease were randomly assigned to receive either Stalevo or a combination of carbidopa and levodopa. The patients were treated for an average of 2.7 years. Unexpectedly, researchers found that a greater number of patients taking Stalevo had prostate cancer compared to those taking carbidopa/levodopa. Statistical analysis revealed that the risk of prostate cancer among Parkinson’s patients taking Stalevo was over 4 times higher.

The FDA is performing an ongoing review of Stalevo and, at this time, it has made no new recommendations about the use of this Parkinson’s treatment. The agency advises healthcare professionals to be aware of the potential risk associated with Stalevo and to follow current guidelines for prostate cancer screening among Parkinson’s patients who are receiving this combination treatment.

Source:

U.S. Food and Drug Administration Drug Safety Communication. Published 31 March 2010.