Multaq Health Risks Lead to New FDA Recommended Restrictions

Federal health regulators have called for new limits on the use of Multaq, indicating that the relatively new heart drug may double the risk of death, stroke and heart failure in patients with permanent atrial fibrillation.

The FDA issued a Multaq safety warning on Monday, announcing that it had completed a safety review of the Sanofi drug and was making new label changes to recommend that it not be used in patients whose abnormal heart rhythms were permanent.

The findings are new being weighed to determine whether the benefits of Multaq outweigh the risks of cardiovascular death, stroke and heart failure. If the agency determines the drug’s benefits are not worth its risks, the FDA could call for a Multaq recall.

The FDA now recommends that patients taking Multaq have their heart rhythms monitored at least once every three months. If the patient is in atrial fibrillation, then use of Multaq should be stopped or they should be cardioverted if clinically indicated

The decision was reached by the FDA after an examination of data from a clinical trial known as PALLAS, which was a test by the manufacturer to see if Multaq could be used to treat permanent and recurring heart rhythm problems. However, the PALLAS trials were cancelledthis summer due to an alarming number of heart attacks, strokes and deaths experienced by users, which has raised concerns over the possibility of Multaq heart problems.

There have also been growing concerns over the risk of liver damage from Multaq. Earlier this year, the FDA warned that at least two Multaq patients suffered liver failure that required them to get organ transplants. There have been other reports of Multaq liver damage as well.

Multaq (dronedarone) was approved in July 2009 for the treatment of patients who have had abnormal heart rhythms in the last six months. In less than two years since its approval, there have been at least 492,000 Multaq prescriptions in the United States filled by about 147,000 patients at outpatient pharmacies across the country. In addition, the drug can be given to patients being treated in hospitals.