A study presented at a recent American Heart Association's annual meeting found that patients with permanent atrial fibrillation who took the heart drug Multaq had double the risk of death when compared to patients who took a placebo. This study unfortunately adds "increased risk of death" to the ever-expanding list of problems associated with Multaq use - which also includes liver failure.
Results of the Study
The study - which was also known as the PALLAS study - was published in the New England Journal of Medicine. And even though the results of the study were just recently presented, the research was actually halted last summer by Sanofi - the company that manufactures Multaq. Sanofi stopped the research when a "significant increase in cardiovascular events" became apparent.
Some of the "cardiovascular events" likely concerning to Sanofi probably stem from that fact that the study discovered that there were 21 cardiovascular related deaths in patients taking Multaq, while only 10 deaths in those taking the placebo. The study also concluded that the rate of stroke and heart failure rose significantly in patients taking Multaq.
FDA Response
The FDA also just recently completed a safety review of Multaq - relying on data from not only the PALLAS clinical trial, but another clinical trial named ATHENA. Following the review, the FDA and Sanofi initiated label changes and recommendations in an effort to handle the serious risks associated with Multaq use. According to the FDA, these changes included adding the following to the Multaq drug label:
- Healthcare professionals should not prescribe Multaq to patients with atrial fibrillation who cannot or will not be converted into normal sinus rhythm (permanent atrial fibrillation), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients
- Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in atrial fibrillation, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted
- Multaq is indicated to reduce hospitalization for atrial fibrillation in patients in sinus rhythm with a history of non-permanent atrial fibrillation (known as paroxysmal or persistent atrial fibrillation)
- Patients prescribed Multaq should receive appropriate antithrombotic therapy
The risks associated with Multaq use seem to be mounting. If you or a loved one has suffered adverse reactions while taking Multaq, contact an experience Multaq attorney to be advised of your rights and options.
