The Cochran Firm Legal Blog

The Food and Drug Administration is investigating the Parkinson's drug Stalevo due to concerns it may increase the risk of heart attack, stroke, and death. The FDA states patients should not stop taking the drug, but should contact their physician if they are at risk for cardiovascular disease.

Stalevo is a drug manufactured by Novartis. It is a combination of the three drugs carbidopa, entacopone, and levodopa. Carbidopa and levodopa are sold as a combination under the brand name Sinemet. It is routinely given to Parkinson's patients as standard therapy. Entacapone is sold under the name Comtan. There is reportedly no benefit to Parkinson's by itself, but enhances the effects of the other two drugs.

The FDA says the first indication that something was wrong with Stalevo came from a clinical trial called STRIDE-PD. 373 patients took Stalevo and 372 received carbidopa/levodopa. The average age of patients in the drug trial was 60. The average length of the trial was almost three years. There were seven heart attacks and one death in the Stalevo group and none in the other group.

The results of STRIDE-PD were compared with 14 other trials totaling 4800 patients. In the Stalevo group, there were 27 heart attacks, strokes, or deaths; there were ten in the carbidopa/levodopa group. When the data from STRIDE-PD was included, there was a risk increase of nearly 150%. When it was discounted, it was "not statistically significant" at 67%.

The FDA is looking for ways to quantify the potential risks due to limitations of the study. All Parkinson's patients have an increased risk of cardiovascular problems, but the studies were not designed to examine these kinds of risks. Most of the studies had a duration of only six months, rather than the three years of the STRIDE-PD study.

If you or a loved one has had a significant cardiovascular event while taking Stalevo, please contact the experienced defective drug attorneys at the Cochran Firm. We serve clients nationwide.