On Sept. 2, Sanofi announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed that there is a positive benefit-risk balance when using Multaq (dronedarone) as a treatment for paroxysmal and persistent atrial fibrillation (a-fib).
While it’s true that CHMP conducted an analysis and concluded that the benefits of Multaq continue to outweigh the risks, this is only true for a limited group of patients with a-fib, according to the group. What they are saying about Multaq is that the drug shouldn’t be used unless nothing else is working and that patients with left ventricular systolic dysfunction shouldn’t take Multaq at all.
The actual communication by the EMA about the drug says, “Multaq is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation. Due to its safety profile, Multaq should only be prescribed after alternative treatment options have been considered. Multaq should not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.”
This information is going to be sent to European Union healthcare professionals in the form of a Direct Healthcare Professional Communication (DHPC) letter, which will alert them of the updates for the use of Multaq. What all of this information means is that Multaq is still going to be used in Europe, but only when no other options are working. That limits how much the drug can be prescribed. This may be a step forward in preventing patients from getting liver failure or more severe heart problems due to taking the drug.
If you or a loved one have developed liver failure after taking Multaq, contact attorney Greg Jones for a free consultation. You may be eligible to file a lawsuit to receive money for your injuries and I am experienced at fighting drug injury cases like yours.