September 14, 2009 By:Formulary journal staff
In an update to an earlier communication, FDA announced that the manufacturers of the leukotriene inhibitors montelukast (Singular), zafirlukast (Accolate), zileuton (Zyflo), and zileuton extended-release (Zyflo CR) are adding information about neuropsychiatric events to product labeling.
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September 14, 2009 By:Formulary journal staff
Novartis has issued a Dear Healthcare Professional letter regarding a risk of pure red cell aplasia (PRCA) in patients treated with mycophenolic acid (Myfortic).
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September 14, 2009 By:Formulary journal staff
In the Study of Platelet Inhibition and Patient Outcomes (PLATO) published in the New England Journal of Medicine, patients with acute coronary syndrome (ACS) who were treated with ticagrelor had significant reductions in the rate of death from vascular causes, myocardial infarction (MI), or stroke and no significant increase in the rate of overall major bleeding versus patients treated with clopidogrel.
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September 14, 2009 By:Formulary journal staff
Tibotec has issued a Dear Healthcare Professionals letter regarding an increased risk of fatality caused by toxic epidermal necrolysis and hypersensitivity reactions, sometimes accompanied by hepatic failure, in patients treated with etravirine (Intelence).
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September 14, 2009 By:Formulary journal staff
In the Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography III (DECREASE III) trial published in the New England Journal of Medicine, patients undergoing noncardiac vascular surgery who were treated with perioperative fluvastatin demonstrated a lower incidence of myocardial ischemia than patients treated with placebo.
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September 14, 2009 By:Formulary journal staff
FDA is reviewing reports of liver injury in patients treated with orlistat (prescription drug, Xenical; OTC drug, Alli) for obesity management or weight loss.
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August 18, 2009 By:Formulary journal staff
After completing an analysis of safety data for tumor necrosis factor (TNF)-blockers, FDA has stated that there is an increased risk of lymphoma and other cancers in pediatric patients who are treated with these agents.
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August 18, 2009 By:Formulary journal staff
A study published in Urology demonstrated that alpha-blocker use is associated with a lower risk of sexual dysfunction in men aged >40 years.
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August 18, 2009 By:Formulary journal staff
Initiation of antipsychotic therapy associated with hyperglycemia in older diabetic patients
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