"Multaq Not a Very Safe Drug"

Louisville, KYAny doctor will tell you that every drug has side effects—including heart drug Multaq. In fact, Multaq side effects are compelling. But even though the US Food and Drug Administration (FDA) has Multaq under a microscope and issued a cautionary statement about dronedarone (Multaq) as recently as February, the agency is resisting any effort to request a Multaq recall.

This, after Multaq barely made it through the approval process to begin with, according to avid blogger John Mandrola, MD.

A practicing cardiac electrophysiologist based in Louisville, Kentucky, who knows a thing or two about the heart (including the importance of exercise for heart health—he himself is an avid cyclist and bike racer…), Dr. Mandrola makes the point that the randomized ANDROMEDA trial, which served as one of the original studies leading to the approval of Multaq, showed that patients with severe heart failure were twice as likely to die when put on Multaq.

A subsequent trial, dubbed ATHENA, eventually led to Multaq's approval in 2009.

"The ATHENA investigators didn't exactly say that Multaq works," Dr. Mandrola wrote in his blog, Dr. John M, in July of last year, "rather they claimed that it reduced a composite of hospitalizations and death."

The last part of that statement was backed up in the most recent FDA statement, released this past February: "Dronedarone, marketed as Multaq by Sanofi-Aventis is indicated to reduce hospitalizations for atrial fibrillation (AF) in patients in sinus rhythm with a history of nonpermanent AF."

The FDA noted, upon the conclusion of its safety review of dronedarone, that Multaq "provides a benefit for patients with non-permanent AF and recommends that health care professionals who prescribe Multaq follow the recommendations in the revised Multaq drug label."

According to Cardiology News (2/12), the FDA based its conclusions on the preliminary results of a large outcomes study dubbed PALLAS—an initiative halted early when it became clear that cardiovascular events were far higher for study participants on Multaq dosing v. the control group using a placebo.

"Thus far, we could summarize Multaq as an expensive, aggressively marketed AF drug which doesn't work and often makes people feel ill, though less frequently hospitalized," writes Dr. Mandrola in his blog (7/8/11).

And then there's the potential for Multaq liver failure which, according to Dr. Mandrola, is unpredictable and could emerge suddenly and without warning.

However, the biggest concern over Multaq interactions remains the potential for cardiovascular events in patients with permanent AF—hence the FDA caution to doctors that Multaq is only considered appropriate for patients with non-permanent AF.

Be that as it may, when one considers the potential for Multaq liver failure and the need to stop the PALLAS trial early, the light shed upon dronedarone is hardly favorable, in spite of the various marketing efforts by Multaq manufacturer Sanofi to put a positive spin on the drug.

"Taken together," wrote Dr. Mandrola last July, "and along with the original ANDROMEDA trial, these reports suggest that Multaq isn't a very safe drug."