Less than a year after it received FDA approval for its combo cholesterol drug, Merck reported it was recalling tablets due to packaging defects.

Yale University School of Medicine’s Harlan Krumholz, MD, explains in an NPR blog post how patients can use physician disagreement over a change in guideline recommendations concerning blood pressure targets to receive care that suits their wishes. 

Various guidelines appear to be under the magnifying glass these days, with dissenters challenging the need to follow recommendations. This may be part of a healthy debate. But how about instances where cardiologists are penalized for following evidence-based recommendations?

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 in favor of approval for the antiplatelet vorapaxar to reduce atherothrombotic events in patients with a history of MI.

Statistical estimates of mortality risk after cardiac surgery are more accurate than physician estimates based on clinical assessments—also known as the “eyeball test”—although both methods tend to overestimate risk, a study published online Jan. 14 in Circulation: Cardiovascular Quality and Outcomes found.

Administering stem cells after STEMI did not improve left ventricular ejection fraction after one year, according to a research letter published in the Jan. 15 issue of JAMA.

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the New Drug Application (NDA) for its investigational, oral, once-daily direct factor Xa-inhibitor SAVAYSATM (edoxaban) Tablets has been submitted to the U.S. Food and Drug Administration (FDA). In the U.S., Daiichi Sankyo is seeking approval for edoxaban for the reduction in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF), as well as for the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and for the prevention of recurrence of symptomatic venous thromboembolism (VTE). SAVAYSA is the proposed brand name for edoxaban if approved for marketing in the U.S.

A team of cardiologists at the Cleveland Clinic recommended a hybrid approach using previous and new guidelines for treating patients with high cholesterol levels who are at risk of atherosclerotic cardiovascular disease. They praised the simplicity of recently released guidelines but faulted their reliance on randomized clinical trial data and an untested risk calculator.