Federal drug reviewers have launched a safety review into the potential side effects of Stalevo®, a Parkinson’s disease drug that may increase the risk of heart problems & prostate cancer
An Introduction to Stalevo Side Effects
Stalevo has been studied thoroughly in clinical trials. In these studies, the side effects that occurred in a group of people taking Stalevo were documented and compared to side effects that occurred in another group of people taking just carbidopa-levodopa (without the entacapone). This way, it was possible to see what side effects occurred, how often they appeared, and how they compared to the group taking just carbidopa-levodopa. In these studies, the most common Stalevo side effects included:
- Involuntary body movements (dyskinesia) — in up to 25 percent of people
- Nausea — up to 14 percent
- Diarrhea — up to 10 percent
- Urine discoloration — up to 10 percent
- Excessive muscle movements (hyperkinesia) — up to 10 percent
- Slow or diminished muscle movements (hypokinesia) — up to 9 percent
- Dizziness — up to 8 percent
- Abdominal pain (stomach pain) — up to 8 percent
Stalevo Reduction in Dyskinesia Evaluation
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 is still reviewing this study and will make more information available as it develops during the safety review. The agency warned healthcare professionals to be aware of the possible Stalevo prostate cancer risk and urged them to follow current guidelines for prostate cancer screening.