Multaq, a Prescription Drug – Linked to Fatal Liver Damage and Cardiovascular Complications
The prescription drug Multaq (dronedarone tablets) is an anti-arrhythmic medication manufactured by Sanofi-Aventis for patients with paroxysmal and persistent atrial fibrillation (AF) or atrial flutter (AFL). The U.S. Food and Drug Administration approved the drug was 2009 to reduce the risk of cardiovascular complications and hospitalizations in patients with atrial issues.
Liver Failure Reported
In January 2011, two years after the drug’s approval, the FDA notified healthcare professionals and patients about reported hepatocelllular (liver cell) injury and liver failure in patients taking Multaq. The reports included two cases of acute liver failure leading to patient liver transplants. The FDA ordered that Multaq Warnings, Precautions and Adverse Reactions label include liver damage.
FDA Issued Black Box Warning in July 2011
In July 2011, the FDA was reviewing data from a clinical trial that was evaluating the effects of Multaq in patients with permanent atrial fibrillation. The study was stopped early after finding a two-fold increase in stroke and hospitalization for heart failure in patients receiving Multaq compared to patients taking a placebo. The FDA ordered that Multaq is to carry a new black box warning on the label of the product.
A safety review performed by the FDA has been completed and has shown that Multaq “doubles the rate of cardiovascular death, stroke, and heart failure,” in patients with permanent atrial fibrillation. The review was based on data from two clinical trials, the PALLAS trial and the ATHENA trial.
You may be entitled to financial compensation if you or a loved one has suffered one of the following associated with use of Multaq:
- Liver damage
- Liver failure resulting in death
- Liver failure resulting in the need for a liver transplant
- Heart failure
- Heart attack
- Death from a cardiovascular event
Contact a New York Product Liability Attorney
With more than three decades of experience, the law office of Rudolph F. X. Migliore, P.C. has the expertise to help clients hold liable parties responsible for the harm Multaq has caused. Our firm works with nationally recognized associated firm to reach major verdicts and settlements. Call (631) 543-3663 or fill out a contact form for a free Multaq case evaluation.