In the latest update regarding product liability and harmful pharmaceutical interactions, the Food and Drug Administration (FDA) warned that it is investigating the possibility that the combination Parkinson’s drug called Stalevo may increase the risk of heart attack, stroke, and death in elderly patients who are taking the drug. Stalevo is an anti-parkinsonian dopaminergic combination medication, combined of carbidopa, levodopa, and entacapone, that treats Parkinson’s disease. The drug is manufactured by Finnish drugmaker Orion Corporation and is marked by Swiss-based Novartis Pharmaceuticals. Stalevo is currently used to treat adult patients with idiopathic Parkinson’s disease in two scenarios: to substitute with equivalent strength of each of the three components or to replace immediate-release therapy when patients experience the signs and symptoms of end-of-dose “wearing off.”
FDA urged patients not to stop taking the drug, but warned patients to let their physicians know if the patients have risk factors for cardiovascular disease. The first indication of product liability risk for Stalevo came from a clinical trial called STRIDE-PD, according to LA Times. The average age of the patient was 60 years of age and the trial that exposed the risks lasted an average of 2.7 years. The study’s results found seven heart attacks and one death.
The results of the clinical trial were combined by the FDA with results from fourteen other trials totaling about 4800 patients. With the wider patient pool, the analysis showed twenty-seven adverse product reactions of heart attacks, strokes, or deaths for a statistically significant increased risk of 146%. When the data from the trial was not included, the increased risk was only 67% and it was not statistically significant. The FDA is continuing to look into the significance of the clinical trial results.
Click the link to the LA Times to read more about the FDA product liability warnings.