FDA Studying Stalevo for Risk of Prostate Cancer Risk

Washington, DC: The FDA notified healthcare professionals and patients today that it is evaluating data from a long-term clinical trial called Stalevo Reduction in Dyskinesia Evaluation - Parkinson's Disease (STRIDE-PD), that may suggest that patients taking Stalevo may be at an increased risk for developing prostate cancer.

While the FDA has not determined whether there is an absolute association between Stalevo and increased risk for prostate cancer, the data from th STRIDE-PD trial show that nine out of 245 males had prostate cancer in the Stalevo group compared to two out of 222 males in the carbidopa/levodopa group. The incidence rate of prostate cancer was 14 cases/1,000 patient years for Stalevo and 3.2 cases/1,000 patient years for carbidopa/levodopa.

Other controlled clinical trials evaluating Stalevo or Comtan (entacapone) did not find an increased risk of prostate cancer. However, the FDA is warning that healthcare professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening.

Legal Help

If you or a loved one has suffered illness from using any of these products, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Published on Mar-31-10