FDA Reviewing Stalevo for Possible Prostate Cancer Risk

Federal health regulators are investigating a possible prostate cancer risk associated with <"http://www.yourlawyer.com/practice_areas/defective_drugs">Stalevo, a drug used to treat Parkinson’s disease. According to a notice on the Food & Drug Administration (FDA) Web site, data from a long-term clinical trial, known as STRIDE-PD, unexpectedly found that a greater number of patients taking Stalevo had prostate cancer compared to those taking carbidopa and levodopa (sold as Sinemet), a combination medication used to treat Parkinson’s disease.

Stalevo — which contains the active ingredients carbidopa, levodopa and entacapone — is marketed in the United States by Swiss-based Novartis and manufactured by Finnish drugmaker Orion.

The STRIDE-PD trial was a double blind, randomized, parallel group, controlled clinical trial conducted at 77 centers in 14 countries, including 31 sites in the United States, between September 2004 and November 2008. According to the FDA, 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. 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.

The FDA said it is exploring additional ways to better understand if Stalevo actually increases the risk of prostate cancer. The agency pointed out that prostate cancer is most commonly diagnosed in men who are of the same age as men included in the STRIDE-PD trial. Previous controlled clinical trials of shorter duration evaluating Stalevo in Parkinson’s disease have not found an increased risk of prostate cancer.

The FDA has advised that 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, the agency said.

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