Can the Heart Medication MULTAQ Cause Severe Liver Injury
Atrial fibrillation is a huge health issue affecting many individuals. It is estimated that this condition affects 2.3 million Americans. At present, the FDA has approved a variety of treatments.
In 2009, the drug company Sanofi-Aventis began to market dronedarone under the brand name Multaq as an additional medication for atrial fibrillation. Although the FDA approved the marketing of Multaq in July 2009, a petition several years earlier had been denied due to patient safety concerns. According to medical data, in just over a year on the market, around 147,000 patients filled prescriptions for the medication. At the time of approval in 2009, the company estimated that sales would eventually reach $1 Billion a year.
However, medical research now indicates that Multaq may not be the blockbuster medication for atrial fibrillation as marketed by its manufacturer. Researchers at Cedars-Sinai Medical Center are now reporting that the medication is only half as effective as a different generic medication. However, it is not just the effectiveness of the medication that is now being called into question. Patient safety is also an issue.
On January 14, 2001, the Food & Drug Administration (FDA) issued a safety announcement warning health care professionals about the possibility of severe liver damage associated with the medication. Then, on January 28, 2011, the FDA issued a warning letter directly to Sanofi-Aventis. This warning letter follows an FDA inspection in which it was revealed that the drug maker had failed to timely report possible adverse consequences of its medication Multaq. At present, it has been reported that several patients on the medication have suffered liver injury, including two who even suffered acute liver failure requiring them to undergo liver transplants.
This is a potential health issue that has already received some coverage from news outlets in Alabama. In light of the significant number of people suffering from atrial fibrillation and the numerous other treatments available, it is important to continue monitoring developments with Multaq and whether this drug poses a danger of acute liver failure to patients.
UPDATE -- On July 21, 2011, the FDA issued a new warning about the use of Multaq and the increased risk of death or other cardiovascular events. http://goo.gl/ukhdt