Breaking News: European regulators have launched a review of heart medication Multaq following cases of acute liver failure in at least two patients. The investigation could result in banning Multaq throughout Europe.
Multaq Update: 1/24/11
Last week, the European Medicines Agency launched a review of Sanofi-Aventis’ (SNY) Multaq following two cases of acute liver failure in patients taking the drug. The agency stated that a causal relationship with Multaq in the patients could not be excluded and called for “urgent regulatory action” to help manage the possible risk of liver complications.
Such investigations typically take a number of months to determine whether the regulator should maintain, change, or withdraw a drug’s authorization. The drug regulator’s committee will review existing information to weigh the benefits and risks of the drug.
Sanofi said it will send European healthcare professionals a letter detailing the two liver failure cases and give recommendations on liver function testing for patients who have been prescribed the drug. The prescribing information on Multaq will also be revised to include the guidance in the letter. The U.S. FDA already requires that labels of the drug include warnings of a possible liver risk.
Multaq is indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL). In a study of patients with these conditions, patients given Multaq had a greater than two-fold increase in risk of death.