New Clinical Trials Announced Despite Multaq Safety Problems

Despite growing concerns over the side effects of Multaq, a relatively new heart drug made by Sanofi-Aventis, researchers are preparing to launch another clinical trial in an effort to determine whether it can be used safely with another drug, Ranexa.

The new clinical trial, to be known as HARMONY, will include about 150 patients in North America and Europe, and will be led by researchers from the Masonic Medical Research Laboratory in Utica, New York.

Ranexa, a Gilead Sciences drug, is currently approved to treat patients suffering from angina.

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HARMONY will be the fourth clinical trial to involve Multaq. While one clinical trial, ATHENA, resulted in positive findings for the drug, two of the first three, ANDROMEDA and PALLAS, were stopped due to a high rate of patient deaths.

Researchers acknowledged that Multaq will probably never be a drug used widely by general practitioners, due to its health risks. Instead, regardless of the study’s outcomes, Multaq is only likely to be used by cardiologists and electrophysiologists who know how to monitor Multaq patients effectively and safely.

Despite growing concerns surrounding the drug, researchers indicate that they doubt there will be a Multaq recall.

Whether HARMONY will include any additional safety measures for participants in light of the ANDROMEDA and PALLAS trials has not been announced.

Multaq (dronedarone) was approved in July 2009 for the treatment of patients who have had abnormal heart rhythms in the last six months.

In the first two years after its approval, there were 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 was often given to patients being treated in hospitals.

In December, the FDA issued a Multaq safety warning after finding that the drug could double the risk of death, stroke and heart failure in patients with permanent atrial fibrillation. The agency recommends patients taking Multaq have their heart rhythms monitored at least once every three months and should be taken off the drug if they are determined to be in atrial fibrillation.

The decision was reached by the FDA after an examination of data from 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 cancelled this 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.


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