FDA Issues Update on QT Prolongation Risk With Ondansetron
Apr 28, 2017
Overview:The FDA announced that a single 32-mg intravenous dose of ondansetron should be avoided because it can prolong the QT interval and can predispose patients to develop polymorphic ventricular tachycardias (torsades de pointes). Ondansetron is a 5-HT3 receptor antagonist approved as... more
The EMA is planning to review the use of aliskiren-containing medicines
Apr 28, 2017
Overview:By Professor Juan Tamargo, Madrid, Spain The European Medicines Agency is planning to review the use of aliskiren-containing medicines after the ALTITUDE trial, which was terminated prematurely, found no apparent benefit among patients randomized to aliskiren (Rasilez in the EU/Tekturna... more
NICE considers Rivaroxaban cost-effectve for DVT
Apr 28, 2017
Overview:By Professor Juan Tamargo, Madrid, Spain The UK National Institute for Health and Clinical Excellence (NICE) concluded that the oral factor Xa inhibitor rivaroxaban is a cost-effective alternative to warfarin for treatment of deep vein thrombosis (DVT) and prevention of... more
FDA does not approve apixaban for stroke prevention in atrial fibrillation
Apr 28, 2017
Overview:By Professor Juan Tamargo, Madrid, Spain The US FDA said that more data are required before approving apixaban, an oral factor Xa inhibitor, for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The agency requested... more
Severe spruelike enteropathy associated with olmesartan
Apr 28, 2017
Overview:By Professor Juan Tamargo, Madrid, Spain June 22, 2012. The Mayo Clinic (Rochester, Minnesota) reported 22 patients with a severe form of sprue-like enteropathy that appears to be linked to olmesartan. The 22 patients presented chronic diarrhea and a median... more
The first approved gene therapy product in a Western country
Apr 28, 2017
Overview:By Professor Juan Tamargo, Madrid, Spain The agency's Committee for Medicinal Products for Human Use (CHMP) of The European Medicines Agency (EMA) has for the first time recommended recommended the authorization under "exceptional circumstances" for alipogene tiparvovec, an "orphan medicine"... more
Ticagrelor Added to Recommended Agents for MI
Apr 28, 2017
Overview:By Professor Juan Tamargo, Madrid, Spain The new update of the guideline for the management of patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) of the the American Heart Association and the American College of Cardiology Foundation recommended prasugrel,... more
Management and Outcomes of Major Bleeding during Treatment with Dabigatran or Warfarin
Jan 02, 2014
Overview:Background Anticoagulants are important in preventing systemic embolization in patients with atrial fibrillation and preventing pulmonary embolism in patients with venous thromboembolism. However, the risk and management of bleeding complications are a matter of concern. When patients present with major... more