Multaq is prescribed to people who have experienced atrial fibrillation, a fast and irregular heartbeat, or atrial flutter, a fast and regular heartbeat, during the past six months, as well as to people with certain conditions that increase their risk for developing heart problems. The U.S. Food and Drug Administration (FDA) recently completed a safety review of the drug and announced last December that Multaq increases “the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation.” People who have experienced serious adverse side effects while taking this potentially dangerous drug should consult a South Carolina injury attorney to determine whether they may have cause for filing an individual lawsuit or joining a class action effort against Multaq manufacturer Sanofi.
Based on the results of its safety review, which involved data from two clinical studies, the FDA now advises that healthcare professionals do not prescribe Multaq to patients with permanent atrial fibrillation, because the drug “doubles the rate of cardiovascular death, stroke, and heart failure in such patients.” Given how many people in the U.S. suffer from atrial fibrillation, this new restriction could save a significant number of lives. An estimated 2.3 million Americans are affected by atrial fibrillation and approximately 71,000 people die from the condition each year, according to an article in the L.A. Times.
The L.A. Times article also reports on a study out of Cedars-Sinai Medical Center that concluded Multaq is half as effective as the generic alternative amiodarone yet has no fewer side effects. Based on these findings, researchers at Cedars-Sinai have suggested that Multaq be used only after all other drugs have failed, that is, as a second- or third-line drug.
From the time Multaq received FDA approval in July 2009 through October 2011, approximately 1.3 million prescriptions of the drug were dispensed. During that same period, outpatient retail pharmacies in the U.S. distributed Multaq to approximately 278,000 patients. Unless the FDA makes a determination that Multaq’s potential risks outweigh its benefits and decides to pull the drug from the U.S. market, or Sanofi voluntarily withdraws it, Multaq will continue to be available nationwide.
If you have experienced cardiovascular side effects while taking Multaq or your loved one died from a Multaq-related complication, contact a qualified South Carolina injury lawyer today to learn about your legal rights.