U.S. Food & Drug Administration Warns About Multaq Safety


Multaq, a drug used successfully to reduce the risk of death, stroke, and hospitalization for patients with occasional atrial fibrillation have been found to double the risk of death for those with a permanent form of the erratic rhythm. Sanofi’s Multaq is approved for the treatment of patients whose hearts intermittently race with quick and inefficient contractions or who suffer from atrial fibrillation that lasts less than six months.

Multaq was first approved for use in the United States by the FDA in July of 2009 and was indicated for the treatment of atrial fibrillation or atrial flutter in certain patients. Based on safety signals related to liver injury received by the FDA in late 2010, the agency required a Multaq label to change in February 2011. The updated label notes that the use of Multaq should be stopped if liver injury is suspected.

After the drug was approved, analysts estimated that Sanofi-Aventis would earn $1.35 billion in annual sales by 2014. This, in fact, did not happen due to the long list of adverse side effects reported.

In an effort to boost Multaq’s prospects after a decline in sales, Sanofi began a trial aiming to show that the drug can stave off cardiovascular episodes, such as stroke and heart attack, in patients with permanent atrial fibrillation. Sanofi had hoped that a study of 3,236 patients would prove that Multaq would also have success in patients with a more serious form of the condition.

The study was designed to evaluate the effectiveness of Multaq in patients suffering from a permanent form of atrial fibrillation. Among patients receiving Multaq, there were 21 deaths from cardiovascular causes. In the placebo group, there were ten such deaths. The study had to be halted after a monitoring committee found that people taking the drug experienced two-fold increases in death, stroke, and heart failure.


Multaq Warnings Issued

According to the European Medicines Agency (EMA), Multaq should only be prescribed after alternative treatment options. In response to the EMA’s warning, the FDA began conducting its own separate review of the prescription drug.

In January 2011, the FDA issued a warning to patients with atrial fibrillation (abnormal heart rhythms) that Multaq showed twice as many deaths as compared to those who did not take the drug. This warning came as a result of a 3,000-patient trial that Sanofi-Aventis halted after they noticed an increased risk of cardiovascular events among patients with permanent atrial fibrillation

In a similar warning on September 23, 2011, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CMHP) recommended that use of Multaq be restricted. The CMHP began evaluating data as a result of post-marketing reports of severe liver injuries among users of Multaq. The CMHP also reviewed potential cardiovascular injuries following the early termination of a clinical trial of Multaq in an off-label population.

Ultimately, the CMHP determined that use of Multaq as approved increased the user’s risk of injury to the liver and the lungs. As a result of the increased risk of liver and lung injury, the CMHP has recommended that Multaq is used only after other treatment options have been considered, and only in patients in whom atrial fibrillation is no longer present.


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