FDA to review heart risks of Parkinson's drug

WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Friday it will examine the potential heart risks of Novartis AG's Parkinson's drug Stalevo, a combination of two treatments for the debilitating brain disease.

The FDA said studies appeared to show an increase in the risk of heart attack, stroke, and cardiovascular death for people taking the drug, but noted the findings were not clear and that such serious heart problems are not uncommon in Parkinson's patients.

The agency stressed that no patient should stop taking the drug without first speaking with a doctor.

"It is estimated that 154,000 patients were dispensed a prescription for Stalevo from its approval in June 2003 through October 2009," the FDA said in a statement posted here

Stalevo is a combination of carbidopa/levodopa and entacapone. Carbidopa/levodopa is itself sold under the brand name Sinemet.

A meta-analysis -- in which data from several clinical trials are combined -- showed a slight increase in heart risk for patients taking Stalevo versus Sinemet.

"Both Stalevo and Sinemet have been shown to be effective treatments for the symptoms of Parkinson's disease. The addition of entacapone to carbidopa/levodopa has been shown to lead to a greater degree of improvement in some of the symptoms of Parkinson's disease than treatment with carbidopa/levodopa alone," the FDA said.

"Healthcare professionals should regularly evaluate the cardiovascular status of patients who are taking Stalevo, especially if they have a history of cardiovascular disease," the agency advised.

"FDA is exploring additional ways to assess whether Stalevo increases the risk of cardiovascular events, and will update the public when this review is complete."

(Reporting by Lisa Richwine and Maggie Fox, editing by Gerald E. McCormick)