A Year Has Passed Since Trial Halted Due to Multaq Side Effects

Washington, DCIt has been little over a year since a clinical trial exploring the benefits of Multaq and Multaq side effects was halted due to concerns over cardiac events. At the time, the Los Angeles Times (7/7/11) noted Multaq manufacturer Sanofi Aventis had referenced a "significant increase in cardiovascular events" amongst participants of the PALLUS study.

Multaq, according to the Sanofi web site, is used successfully for treatment of non-permanent atrial fibrillation. In other words, were a patient to have experienced an irregular heartbeat for a period of time but has since returned to normal, then Multaq dosing is once again appropriate.

It is when atrial fibrillation is ongoing and chronic, that Multaq dronedarone presents a problem. The PALLUS study was investigating just that—the potential benefits and Multaq interactions on patients with permanent atrial fibrillation, when the PALLUS study was stopped dead in its tracks in July 2011.

Adverse reactions associated with dronedarone also includes the potential for Multaq liver failure.

The primary concern that led to the halt of the PALLUS study remains Multaq heart. While Sanofi, at the time the PALLUS trial was halted, issued a short statement as to the continued appropriateness of Multaq for treatment of non-permanent atrial fibrillation, the manufacturer has since loaded up its Multaq website with useful safety information that explains every nuance concerning the risks and benefits associated with dronedarone.

However, last year cardiologist Dr. Westby Fisher blogged about Multaq and the PALLUS plug being pulled:

"I suspect many doctors will now think long and hard before leaping to dronedarone as their 'first line' therapy despite the current recommendations of our 'guidelines,'" Fisher blogged at the time. "More likely, this drug will be used when there are no other options (and there are those cases)." Fisher blogs as 'Dr. Wes.'

That moves Multaq from the first, to the last line of defense.

There was no mention of the potential for Multaq liver toxicity when the PALLUS trial was halted. However, according to The Times an alert issued by the US Food and Drug Administration (FDA) in January of last year referenced Multaq liver damage in some patients.

Two cases of acute Multaq liver failure resulted in the need for a liver transplant, the FDA said. At the same time that Sanofi Aventis Multaq issued the communiqué regarding the halt to the PALLUS trial, the FDA issued its own warning with regard to the potential for Multaq liver damage.