FDA issues Multaq liver warning
pharmafile | January 17, 2011 | News story | Sales and Marketing | FDA, Multaq, atrial fibrilation, dronedarone
US regulators have warned doctors and patients about the risk of severe liver injury associated with Sanofi-Aventis’ atrial fibrillation (AF) drug Multaq.
The FDA has highlighted two cases of acute liver failure leading to liver transplants in patients taking Multaq (dronedarone).
The US regulator points out such problems are “rare” but information about the potential risk is being added to the ‘warnings and precautions’ and ‘adverse reactions’ sections of the brand’s labeling.
It is a blow to Sanofi, which hopes Multaq will reach blockbuster status, and had received plenty of encouragement in that regard over the past 18 months.
Analysts have suggested US sales of Multaq will reach $128 million for 2010 and $521 million in 2016.
Used to treat patients who have had an abnormal heart rhythm during the past six months, it gained approval in the US in July 2009 and Europe four months later, and is one of the French manufacturer’s most important new products.
In August, UK cost effectiveness body NICE gave it restricted approval as a second line treatment for patients with additional cardiovascular factors whose non-permanent AF has not been controlled by first line therapy, usually involving beta blockers.
And in September, European Society of Cardiology guidelines on treating AF recommended Multaq – helping Sanofi in its goal of convincing cardiologists that it should be used instead of older drugs such as the generic amiodarone.
The FDA has now recommended health professionals advise their patients to contact a doctor immediately if they experience signs and symptoms of hepatic injury or toxicity while on Multaq.
These include anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine or itching.
Doctors should consider obtaining periodic hepatic serum enzymes, especially during the first six months of treatment, the FDA adds.
Bloomberg quotes a company spokesman as saying Sanofi is “working closely” with the European Medicines Agency and other health authorities “for review of this matter”.
Adam Hill
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