Multaq® (generic: Dronedarone Hydrochloride) is a drug used primarily in the treatment of cardiac arrhythmia (irregular heartbeats). Recently, the manufacturer of the drug added a warning to doctors and patients indicating that it has been associated with several reported cases of serious liver injuries. In January of 2011, the company and the U.S. Food and Drug Administration (FDA) disclosed two reports of patients on the drug, each of whom developed acute liver failure requiring liver transplantation. The new warningscaution doctors about the possibility of liver damage, and recommend that patients have their liver function tested both before and during Multaq therapy in order to help reduce the risk and seriousness of liver injury.
The labeling change, while commendable, raises a number of serious questions concerning the risks associated with Multaq. In particular, why was the risk of liver damage not disclosed sooner? What information did the manufacturer know about concerning the possible effects of the drug on the liver, and when did they know it? Why didn’t the company conduct adequate studies concerning possible adverse liver effects prior to marketing of the drug?
A preliminary investigation by The Senators (Ret.) Firm, LLP, indicates that data concerning a possible association between Multaq and liver injury may have been available long before warnings were provided to the medical community. A pharmacology and animal toxicology data review conducted by FDA prior to approval of the product in July 2011, which was obtained by The Senators Firm, raised a number of possible “red flags.” According to the FDA reviewing officers, the drug was shown to metabolize and accumulate in the liver. Further, an animal toxicology review concluded that “target organs of toxicity include the liver, kidneys, gastrointestinal tract and female reproductive tract.”
The drug was also studied by the manufacturer in human subjects before approval. While some data concerning liver function was collected during those so-called “clinical trials,” it appears that patients who might be at a greater risk for liver injury, namely those who had pre-existing liver abnormalities, where intentionally excluded from the studies. Indeed, in its pre-approval review, the FDA noted that “the effect of impaired hepatic [liver] function has not been evaluated, but there is an ongoing study to evaluate this patient population.” It is unclear whether this study was ever completed, although the labeling for the drug continuously has stated that “there is little clinical experience with moderate hepatic impairment and none with severe impairment.”
It is also significant that in September 2010, a report of a patient who developed symptoms of liver dysfunction was published in the Annals of Pharmacotherapy. While the authors attributed their patient’s liver abnormalities to the worsening of his heart condition, they suggested that the cardiac problems may have been related to the drug which then led to secondary injury to his liver and kidneys. In any event, the possibility of direct liver toxicity related to Multaq was not ruled out, and one wonders whether and how the manufacturer evaluated this published report internally.
Severe liver injuries are not infrequently associated with pharmaceutical products, largely because the liver is often an organ in which drugs are metabolized and may accumulate over time. It is vitally important for doctors to be aware of drugs that have the potential to cause liver toxicity so that they can adequately warn their patients and take precautionary measures, including the screening of patients with underlying liver dysfunction who may be at particular risk.
The full story behind the liver risk associated with Multaq has not yet been told. However, there does appear to have been data available both before and after approval of the drug suggesting a potential for liver toxicity, which begs the question of whether the drug’s manufacturer acted appropriately in failing to warn about the risk until January 2011. More troubling is the question of how many more patients may have developed life-threatening liver problems as the possible result of Multaq ingestion in addition to the two patients reported by the FDA.
The Senators (Ret.) Firm will continue to update its investigation as additional facts become available.
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If you or a loved one has been injured by Multaq, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.