The Food and Drug Administration (FDA) recently issued a safety warning for people taking the drug Multaq (dronedarone), a drug approved two years ago for the treatment of irregular heart rhythms.
The FDA warning cited data from a recently cancelled study that was being performed by Sanofi-Aventis, the maker of Multaq. In the study, twice as many deaths occurred in a group of people taking Multaq compared to a group that did not take the drug.
The FDA approved Multaq in 2009 for the treatment of arrhythmia lasting less than six months, a condition called short-term or non-permanent atrial fibrillation. Since then 241,000 Americans have received prescriptions for the drug. The study was being conducted to determine whether Multaq could be used to treat permanent or long-term atrial fibrillation.
Multaq is an important new drug for pharmaceutical company Sanofi-Aventis. The company had sales of $246 million for Multaq last year.
The warning advises all patients taking Multaq to consult their physician to determine whether they should continue taking the drug. It also tells doctors to not prescribe Multaq for the treatment of long-term arrhythmias.
If you or someone you know has had a serious adverse reaction to Multaq, consider consulting an experienced attorney who can advise you of your legal rights.
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