Patients with the condition of non permanent cardiac arrhythmia are typical candidates for dronedarone. Approved by the FDA in July of 2009, dronedarone is manufactured by Sanofi-Aventis, is also known as SR33589, and was marketed as Multaq. Dronedarone, CAS number 141626-36-0, can be an essential treatment for both atrial fibrillation and atrial flutter. LGM Pharma is a provider of the API dronedarone CAS# 141626-36-0 for research and development.
Offered as 400 milligram tablets, dronedarone is appropriate for patients with non-permanent atrial fibrillation/flutter (AF/AFL). As of July 21, 2011 the FDA voiced concern over the use of dronedarone in patients with permanent AF. Preliminary studies using the brand Multaq for this patient population indicated a two fold increase in death, stroke and hospitalization for patients who received Multaq versus a placebo. This study, deemed PALLAS, is currently under review by the FDA. Providers must be cognizant and not prescribe dronedarone to any patients with permanent AF or AFL until further direction from the FDA is disseminated.
Usually given as a twice daily dosage, dronedarone should not be dispensed to patients who have ever been diagnosed with heart failure. Side effects include rash, heartburn, weakness and diarrhea. Patients must tell their doctors if they already take anticoagulants, beta-blockers, certain antidepressants and vitamins or supplements, as these may alter the efficacy of dronedarone. Information about the potential risk of severe liver injury was added by the FDA to the label for dronedarone in January 2011, amid concerns of possible hepatic injury and/or toxicity. This was deemed as an urgent communication from the FDA after two liver transplant cases came to light from patients who had been treated with Multaq. Recommendations from the FDA suggest that patients taking dronedarone for atrial fibrillation should be monitored at least every three months to document the absence of their arrhythmia.
Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.