The US Food and Drug Administration today approved the anti-clotting drug Eliquis ( apixaban ), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

The US Food and Drug Administration (FDA) is informing healthcare professionals and the public that the blood thinner (anticoagulant) Pradaxa ( dabigatran etexilate mesylate ) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves.

The US Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.

On November 9, 2012, Ranbaxy Inc. initiated a voluntary recall of 41 affected lots of atorvastatin calcium tablets (10 mg, 20 mg and 40 mg) which is a solid oral dosage form, to the retail level.

The US Food and Drug Administration today approved the HeartWare Ventricular Assist System, a left ventricular assist device (LVAD), to support heart function and blood flow in patients with end-stage heart failure who are awaiting a heart transplant.

The U.S. Food and Drug Administration approved the Zilver PTX Drug-Eluting Peripheral Stent ( Zilver PTX Stent), the first drug-eluting stent indicated to re-open a particular artery in the thigh ( femoropopliteal artery) when narrowed or blocked as a result of peripheral artery disease (PAD).

The US Food and Drug Administration today expanded the approved indication for the Sapien Transcatheter Heart Valve (THV) to include patients with aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical complications or death.

The US Food and Drug Administration (FDA) is informing the public about a possible increased risk of heart failure with Mirapex (pramipexole), a drug used to treat Parkinson’s disease and restless legs syndrome.

The U.S. Food and Drug Administration approved generic versions of the blood thinning drug Plavix ( clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.

The U.S. Food and Drug Administration (FDA) has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya ( fingolimod ).