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FDA Drug Safety Communication: Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and possible development of Prostate Cancer


The U.S. Food and Drug Administration (FDA) is evaluating clinical trial data that may suggest that patients taking Stalevo, a Parkinson's disease medication, may be at an increased risk for developing prostate cancer. In this trial, patients taking Stalevo were compared to those taking carbidopa and levodopa (sold as Sinemet), a combination medication also used to treat Parkinson's disease.
At this time, FDA's review of Stalevo is ongoing and no new conclusions or recommendations about the use of this drug have been made.
Stalevo contains a combination of the active ingredients entacapone, carbidopa, and levodopa. Entacapone is also available as a single-ingredient product sold under the brand name Comtan. Both Stalevo and Comtan are used to treat symptoms of Parkinson's disease.
The data being reviewed are from a long-term clinical trial called Stalevo Reduction in Dyskinesia Evaluation – Parkinson's Disease (STRIDE-PD) . STRIDE-PD evaluated the time to onset of dyskinesia (difficulty controlling voluntary movement) in patients with Parkinson's disease taking Stalevo compared to those taking only carbidopa/levodopa. An unexpected finding in the trial was that a greater number of patients taking Stalevo were observed to have prostate cancer compared to those taking carbidopa/levodopa.
The agency is exploring additional ways to better understand if Stalevo actually increases the risk of prostate cancer. Previous controlled clinical trials of shorter duration evaluating Stalevo in Parkinson's disease have not found an increased risk of prostate cancer (see Data Summary below), and prostate cancer is most commonly diagnosed in men who are of the same age as men included in the STRIDE-PD trial.
Healthcare professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening.
Patients should not stop taking their medication unless directed to do so by their healthcare professional.
This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. The agency will update the public as soon as this review is complete.

Additional Information for Healthcare Professionals
• In the STRIDE-PD trial, there were a higher number of cases of prostate cancer in subjects in the Stalevo group compared to those in the carbidopa/levodopa group.
• Other controlled clinical trials evaluating Stalevo or Comtan did not find an increased risk of prostate cancer.
• FDA is still reviewing the available information and has not concluded that Stalevo increases the risk of developing prostate cancer
• Follow the recommendations in the drug label when prescribing Stalevo or Comtan.
• Continue to monitor patients for the development of prostate cancer as recommended by the current prostate cancer screening guidelines since most men taking Stalevo or Comtan are in the age groups most often associated with this disease.
Additional Information for Patients
• FDA has not concluded that Stalevo increases the risk of developing prostate cancer. The Agency is still reviewing the available information on this safety concern.
• Do not stop your treatment with Stalevo or Comtan unless told to do so by your healthcare professional.
• Talk to your healthcare professional if you have concerns about Stalevo or Comtan.

Report Adverse Dug Reactions to the SFDA:

The SFDA urges both healthcare professionals and patients to report side effects from the use of botulinum toxin products to the SFDA either online, by regular mail or by fax, using the following contact information :
National Pharmacovigilance Center (NPC)
Saudi Food and Drug Authority-Drug sector
3292 Northern Ring Road
Al Nafal District
Riyadh 13312 – 6288
Kingdom of Saudi Arabia
Email :