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Clinical News

Leukotriene inhibitors associated with neuropsychiatric events

September 14, 2009

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.

Mycophenolic acid associated with increased risk of pure red cell aplasia

September 14, 2009

Novartis has issued a Dear Healthcare Professional letter regarding a risk of pure red cell aplasia (PRCA) in patients treated with mycophenolic acid (Myfortic).

Ticagrelor associated with lower rate of death from vascular causes, MI, and stroke

September 14, 2009

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.

Etravirine associated with severe skin and hypersensitivity reactions

September 14, 2009

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).

Perioperative fluvastatin treatment associated with improved CV outcome after noncardiac vascular surgery

September 14, 2009

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.

FDA issues early communication about ongoing safety review of orlistat

September 14, 2009

FDA is reviewing reports of liver injury in patients treated with orlistat (prescription drug, Xenical; OTC drug, Alli) for obesity management or weight loss.

New warnings about malignancies in pediatric patients added to labels of TNF-blockers

August 18, 2009

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.

Alpha-blocker use in men associated with decreased incidence of sexual dysfunction

August 18, 2009

A study published in Urology demonstrated that alpha-blocker use is associated with a lower risk of sexual dysfunction in men aged >40 years.

Initiation of antipsychotic therapy associated with hyperglycemia in older diabetic patients

August 18, 2009

Initiation of antipsychotic therapy associated with hyperglycemia in older diabetic patients

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