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Stalevo 125 FDA Alerts

The FDA Alert(s) below may be specifically about Stalevo 125 or relate to a group or class of drugs which include Stalevo 125 (carbidopa/entacapone/levodopa).

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for carbidopa/entacapone/levodopa

Entacapone: Drug Safety Communication - FDA Review Found No Increased Cardiovascular Risks

Oct 26, 2015

Audience: Neurology

Including Comtan (entacapone) and Stalevo (entacapone, carbidopa, and levodopa)

ISSUE: An FDA safety review has found no clear evidence of an increased risk of heart attacks, stroke, or other cardiovascular events associated with the use of entacapone for the treatment of Parkinson’s disease. As a result, recommendations for using Comtan (entacapone) and Stalevo (a combination of entacapone, carbidopa, and levodopa) will remain the same in the drug labels.

FDA alerted patients and health care professionals about a possible increased risk for cardiovascular events and death with Stalevo in August 2010. This possible safety issue was observed in a clinical trial called the Stalevo Reduction in Dyskinesia Evaluation in Parkinson’s Disease (STRIDE-PD) and in a meta-analysis that combined the cardiovascular-related findings from 15 clinical trials comparing Stalevo to carbidopa/levodopa. Carbidopa and levodopa have been used extensively and have not been shown to have an increased cardiovascular risk. FDA was concerned that the entacapone in Stalevo was responsible for these cardiovascular risks because the comparison drugs do not contain this ingredient.

To better understand the significance of these findings, FDA required the Stalevo manufacturer, Novartis, to study the potential for cardiovascular risk with the entacapone component of the drug. FDA examined the results from this required study and from one additional study and concluded they do not show an increased risk of cardiovascular adverse events with entacapone. The results observed in the original meta-analysis were driven by results of a single study (STRIDE-PD), which was not designed to assess cardiovascular risks. FDA believes that the meta-analysis and STRIDE-PD results are chance findings and do not represent a true increase in risk due to entacapone.

BACKGROUND: Entacapone-containing products, Comtan and Stalevo, have been shown to be effective in treating symptoms of Parkinson’s disease, such as muscle stiffness, tremors, spasms, and poor muscle control. The combination of entacapone with carbidopa and levodopa in Stalevo has been shown to reduce end-of-dose “wearing-off” in patients with Parkinson’s disease to a greater degree than with entacapone alone or with the two-drug combination of carbidopa and levodopa.

RECOMMENDATION: Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[10/26/2015 - Drug Safety Communication - FDA]

Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk

Aug 20, 2010

Audience: Neurology, Cardiology

Issue: FDA notified healthcare professionals that it is evaluating clinical trial data that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for cardiovascular events (heart attack, stroke, and cardiovascular death) compared to those taking carbidopa/levodopa (sold as the combination product, Sinemet). FDA's decision to conduct a meta-analysis was based on findings from the Stalevo Reduction In Dyskinesia Evaluation – Parkinson's Disease or STRIDE-PD trial, which reported an imbalance in the number of myocardial infarctions in patients treated with Stalevo compared to those receiving only carbidopa/levodopa. Although myocardial infarction, cardiac irregularities, hypertension, and palpitations have been reported with levodopa, previous clinical trials with Stalevo did not show an imbalance in myocardial infarction, stroke, and cardiovascular death.

Background: 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. Entacapone is also available as a single ingredient product (sold under the brand name Comtan) to be always administered in association with carbidopa/levodopa (entacapone has no antiparkinsonian effect of its own). It is estimated that 154,000 patients were dispensed a prescription for Stalevo from its approval in June 2003 through October 2009.

Recommendations: At this time, FDA's review of the potential cardiovascular risk with Stalevo is ongoing. Healthcare professionals should regularly evaluate the cardiovascular status of patients who are taking Stalevo, especially if they have a history of cardiovascular disease. Patients should not stop taking Stalevo unless told to do so by their healthcare professional.

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.

[08/20/2010 - Drug Safety Communication - FDA]

Related MedWatch Safety Alert, March 2010 


Stalevo (entacapone/carbidopa/levodopa): Ongoing Safety Review

Mar 31, 2010

Audience: Neurology, Oncology, and Family Medicine

FDA notified healthcare professionals and patients that it is evaluating data from a long-term clinical trial called Stalevo Reduction in Dyskinesia Evaluation - Parkinson's Disease (STRIDE-PD), that may suggest that patients taking Stalevo may be at an increased risk for developing prostate cancer. Other controlled clinical trials evaluating Stalevo or Comtan (entacapone) did not find an increased risk of prostate cancer. FDA is still reviewing the available information and has not concluded that Stalevo increases the risk of developing prostate cancer. Healthcare professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening.  FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing Stalevo and Comtan.  Patients should not stop taking their medication unless directed to do so by their healthcare professional.


[03/31/2010- Drug Safety Communication - FDA]


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