Taking medications for a condition always has a risk of adverse effects, or even possibly developing a different disease. These risks are weighed carefully between a person and their doctor, and then an individual decision is made. In 2010, a clinical trial took place that showed a possible increased risk of prostate cancer with one of the components of the drug Stalevo, which is used to treat Parkinson’s disease (PD). Stalevo is a drug that contains entacapone, carbidopa, and levodopa. It was the entacapone part that scientists thought increased the risk of prostate cancer. Once this possible risk was noted, it was further studied by the Food and Drug Administration (FDA).
What does Stalevo do?
Stalevo is a medication that includes entacapone, carbidopa, and levodopa. This combination was found to be effective in treating symptoms of PD like muscle stiffness, poor muscle control, tremors, and spasms.1 These drugs were used for several decades, and this combination of medications was found to lower the “wearing off” seen at the end of the dose for those with PD, than with any of the drugs by themselves or even the combination of carbidopa-levodopa.1
How did the FDA come to this conclusion?
The FDA reviewed the original study that found the supposed increased risk of prostate cancer, which was called the Stalevo Reduction in Dyskenesia Evaluation – Parkinson’s Disease (STRIDE-PD) trial. The study was found to have limitations in the design and data analysis. There was not enough information in the study about family history of prostate cancer or prior screenings for prostate cancer. Also, the possibility of not screening regularly for prostate cancer in those with advanced PD was not considered.1
In a new study conducted by the FDA and Veterans Affairs Center for Medication Safety, researchers looked at individuals with PD taking levodopa-carbidopa, with one group having an add-on therapy of entacapone, and the control group having a dopamine agonist or a monoamine oxidase B inhibitor.1 Researchers found no difference in the risk of prostate cancer between the two groups for the duration of treatment, which was more than two years.1 There was also no association between the cumulative dose and risk of prostate cancer.1
Things to consider
Talk with your doctor about your family history of prostate cancer or other diseases, and go over the risks and benefits of taking Stalevo. This can help put your mind at ease, knowing the specific risks pertinent to your own medical history. Continue seeing your primary care physician and get regular prostate cancer screenings and/or any follow-ups.
FDA Review Finds No Increased Risk of Prostate Cancer with Parkinson’s Disease Medicines Containing Entacapone (Comtan, Stalevo). U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/fda-review-finds-no-increased-risk-prostate-cancer-parkinsons-disease-medicines-containing Published August 13, 2019. Accessed September 26, 2019.