855.646.4355 | En Español
New Heart Warnings Issued for Multaq
Serving Alabama, Mississippi & Florida including Mobile, Pascagoula, Gulfport, Biloxi & Pensacola
Wed, 12/21/2011
More safety problems have been uncovered with the drug, Multaq. Multaq had previously been the subject of several safety concerns, before it was approved and after. The new warnings added by Federal health officials came about because company studies showed that the drug had higher rates of heart attack, stroke and death in a subset of patients.
Multaq (dronedarone) is a Sanofi-Aventis drug that was approved for sale in July of 2009. It is approved to treat abnormal heart rhythms, also known as atrial fibrillation. When first approved it was known that it carried an increased risk of death for patients with severe heart failure. In the first two years it was on the market, approximately 278,000 prescriptions were filled in the U.S., and about $224 million in sales were reported in 2010.
Later, in January 2011, the FDA warned about reports of liver failure associated with the drug, often resulting in liver transplant. In July 2011, a study involving Multaq was stopped after it was discovered that users of the drug faced an increased risk of heart problems. The study found that users may be subjected to a doubling of the risk of cardiovascular problems, including heart attack, stroke and death, if they were older and had permanent atrial fibrillation. The new label for the drug, posted online on Monday of this week, reflects the findings of this study.
The new label instructs doctors to check patients' heart rhythm at least once every three months. If patients have permanent atrial fibrillation the drug should be discontinued. European Union health officials, who typically act much faster than the FDA on safety issues, have already restricted Multaq's use based on this same safety information.
- Login to post comments
- Send to friend
- PDF version
