FDA: Stalevo may increase male patients' risk of cancer

SILVER SPRING, Md. Data from a long-term clinical trial may indicate a possible cancer risk in men taking a drug for treating Parkinson’s disease, the Food and Drug Administration said Wednesday.

The agency notified healthcare professionals and patients that it was evaluating data from the STRIDE-PD trial indicating a possible risk of prostate cancer in patients taking the Novartis drug Stalevo (carbidopa, levodopa and entacapone). It cautioned, however, that it had not concluded that a risk existed and that other clinical trials evaluating Stalevo and a related drug, Comtan (entacapone), did not show an increased prostate cancer risk.

Novartis issued the following statement in response to the FDA report: “Novartis is coordinating with the FDA as it evaluates data from the STRIDE-PD study related to an unexpected imbalance in reports of prostate cancer cases. STRIDE-PD was conducted in patients with early Parkinson’s disease to investigate a potential new indication outside the terms of the current label. Previous controlled clinical trials have not found an increased risk of prostate cancer.”

Stalevo and Comtan had collective sales of $217 million in 2009, according to Novartis financial reports.