Stalevo Heart Side Effects to be Reviewed by FDA

Federal drug reviewers have launched a safety review into the potential side effects of Stalevo, a Parkinson’s disease drug that may increase the risk of heart problems. 

The FDA announced its ongoing safety review of the Stalevo heart risk on Friday, indicating that doctors should regularly evaluate the cardiovascular status of patients taking the drug, especially if they have a history of cardiovascular disease. However, the FDA has not concluded that Stalevo increases the risk of heart attacks, stroks or cardiovascular death, as data is still being reviewed. The agency has indicated that consumers should not stop taking the medication unless told to do so by their healthcare provider.

The agency previously placed the drug under a safety review in April due to potential concerns about prostate cancer from Stalevo after data from a long-term clinical trial resulted in an unusual number of men developing the disease. That review is also still on-going.

Stalevo (entacapone/carbidopa/levodopa) is a prescription drug by Novartis used to treat dyskinesia (movement disorder) associated with the onset of Parkinson’s disease. The drug was approved by FDA in June 2003. The agency estimates that 154,000 people have been prescribed the drug since its approval.

Concern over the Stalevo heart side effects stem from a meta-analysis of 15 clinical trials that suggest that the medication could increase the risk of heart attack, stroke and cardiovascular death among users. But the FDA warns that the clinical trials were not designed to look for heart problems from Stalevo and that the majority of the patients already had an increased risk of cardiovascular disease. Parkinson’s disease is also known to often increase the risk of heart attack and stroke.

An earlier study, known as Stalevo Reduction In Dyskinesia Evaluation – Parkinson’s Disease (STRIDE-PD) looked at 373 patients using Stalevo and 372 patients being given the drug combination of carbidopa and levodopa. In that study, eight Stalevo patients suffered heart attacks, one of whom died. No patients from the other group suffered heart attacks.

The STRIDE-PD study also lead to the suggestion that the drug was linked to prostate cancer.

Following the results of STRIDE-PD, the FDA decided to conduct a meta-analysis that looked at a total of 4,800 patients on Stalevo or carbidopa/levodopa. There were 27 cardiovascular events in patients given Stalevo, and only 10 in patients given carbidopa/levodopa. However, FDA officials say that once the STRIDE-PD results are removed from the rest of the data, the difference becomes statistically insignificant.

The FDA is continuing to explore additional ways to assess whether Stalevo side effects increase the risk of heart problems, and indicates that they will update the public when the review is complete.