Product Liability

Parkinson’s drug may increase risk of prostate cancer

A drug used to treat Parkinson’s disease may put patients at greater risk for prostate cancer, according to Food and Drug Administration (FDA) drug safety announcement. The drug in question, Stalevo, is a treatment that combines the active ingredients entacapone, carbidopa and levodopa.

The agency said it is evaluating clinical trial data from the Stalevo Reduction in Dyskinesia Evaluation – Parkinson’s Disease (STRIPE-PD), which looked at the time of onset of dyskinesia, or difficulty controlling voluntary movement, in patients with Parkinson’s disease taking the drug Stalevo compared to those taking only carbidopa/levodopa. Researchers unexpectedly found a greater number of patients taking Stalevo who were observed to have prostate cancer compared to those taking carbidopa/levodopa. According to the clinical trial data, 9 out of 245 males, or 3.7 percent, had prostate cancer in the Stalevo group compared to the 2 out of 222 males, or 0.9 percent, the carbidopa/levodopa group

The FDA is quick to point out that prostate cancer is most commonly diagnosed in men who are of the same age as men included in the STRIDE-PD trial and that patients should not stop taking Stalevo unless told to do so by their health care professional. The evaluation is ongoing as the agency explores additional ways to better understand if Stalevo actually increases the risk of prostate cancer. Previous controlled trials on a shorter duration have not found an increased risk of prostate cancer.

Health care professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening.