The FDA has decided to use some more restrictions on the approved use of the atrial fibrillation (AF) drug Multaq after studies have shown the drug can double a patient’s risk of dying of heart attacks, strokes and heart failure while taking the drug for treatment of permanent atrial fibrillation.
The FDA issued its Multaq safety warning on Monday, December 19. The announcement stated that the regulators completed a safety review of Multaq and that they were going to change the drug’s labels to reflect that it not be used in patients who suffer from permanent AF. These newest findings by the FDA are meant to give the agency time to figure out the risks-to-benefits ratio with more reviews. If the agency decides that the risks aren’t worth it, Multaq may just end up being recalled altogether.
For now, the FDA now is recommending that Multaq only be given to patients with temporary AF, and that those patients have their heart rhythms monitored at least once every three months. If any of the tests show that the patient is in atrial fibrillation, Multaq use will be stopped. When making this decision, the FDA reviewed data from the PALLAS study, which was halted earlier this year because patients started dying after their heart problems got worse.
Worsening heart conditions aren’t the only complication linked to Multaq. Patients have also been developing liver failure. For now, the maker of Multaq, Sanofi-Aventis, is hoping a recall isn’t issued against the drug. But doctors are getting more and more concerned about prescribing the drug to patients.
If you or a loved one have developed liver failure or a worsening heart condition after taking Multaq, contact attorney Greg Jones today for a free consultation. I am experienced fighting Multaq lawsuits and may be able to help you recover money for your injuries.
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