Multaq (also known as dronedarone) was approved by the Food & Drug Administration (“FDA”) in July of 2009 as an anti-arrhythmic drug for use in heart patients with persistent atrial fibrillation, which is the most common cardiac arrhythmia (abnormal heart rhythm), or paroxysmal (irregular heart rhythm). The drug is manufactured and marketed by Sanofi-Aventis. Multaq carries a “black box warning” which is the strongest level of warning on a prescription drug. The warning informs physicians that Multaq should not be prescribed for patients with severe congestive heart failure due to concerns that use of the drug might worsen patients’ heart failure symptoms or increase their chance of dying.
In the few short years that Multaq has been sold by Sanofi-Aventis, the heart drug has been in the news quite a bit, but not because of its wonderful benefits for patients. Instead, there is growing evidence that the drug is dangerous which has led to a great deal of fear for patients and apprehension among prescribing physicians:
• Early 2010 – The FDA warned of possible problems with the development of congestive heart failure in patients taking Multaq.
• Spring 2010 – The FDA warned of a possible link between Multaq and a potentially fatal ventricular arrhythmia known as torsade de pointes. Other drugs, such as Propulsid, have been recalled due to links to this same life-threatening arrhythmia as well as an electrical conduction problem in the heart known as “long QT syndrome.”
• February 2011 – Multaq’s warning label was enhanced yet again to include the risks of acute liver failure or hepatic toxicity. The symptoms associated with acute liver failure include abdominal pain, anorexia, dark urine, fever, itching, jaundice, malaise, nausea and vomiting.
• March 2011 – The drug warning label was further changed to discuss the potential for drug interactions, especially with Warfarin (also known as Coumadin), a blood thinner that is commonly prescribed to patients with cardiovascular disease.
• June 2011 – Yet again, Multaq’s warning label was amended to note that some patients who have taken the drug had developed serious pulmonary and respiratory problems, including interstitial lung disease, pneumonitis, and pulmonary fibrosis.
• August 2011 – The warning label for dronedarone was again modified to reflect that patients may experience changes in their kidney function while taking Multaq. In addition, patients who have suffered serious adverse reactions were urged to report them to the FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. Patients have been cautioned to consult with their doctor prior to discontinuing Multaq, as there are serious potential side effects if patients abruptly stop taking this medication.
• September 2011 – The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use, the drug safety organization similar to the FDA that oversees drug safety in the European Union, met to discuss safety concerns over Multaq and whether the drug should continue to be prescribed in Europe. In the past, unlike the FDA, the EMA has shown that it is more inclined to move swiftly to recall dangerous drugs and to put the welfare of patients before the interests of the pharmaceutical industry. The EMA recommended that the use of Multaq be limited in light of evidence that the drug was associated with serious adverse effects on the liver, heart and lungs.
So, where does this leave patients who have been prescribed Multaq in the past or who are currently taking the drug? Those patients need to consult with their physicians and request that the prescribers explain the most current safety information available. Each patient needs to frequently assess and reassess with the guidance of their doctor whether the benefits of continued use of Multaq outweigh the risks. While doctors and patients struggle with these critical issues, one can only hope that the drug manufacturer is putting patient safety above profits and thoroughly evaluating whether it can ethically continue to market a product with such a spotted safety history. We also can only hope that the FDA puts the protection of patients above the protection of the financial interests of drug companies of Sanofi-Aventis, an issue for which the Agency has been criticized in the past.
Brenda Fulmer is a shareholder at the law firm Searcy Denney Scarola Barnhart & Shipley in West Palm Beach and partners with Pasternack Tilker Ziegler Walsh Stanton & Romano in the litigation of drug and pharmaceutical mass tort cases. Ms. Fulmer graduated from the University of South Florida with a B.S. in Finance, and received her Juris Doctor degree cum laude from Stetson University College of Law. For the past 17 years, she has represented thousands of mass torts plaintiffs in both state and federal courts who have been injured by defective medical devices and drugs.
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