October 1, 2009 By:Steven B. Russek, RPh
Specialty pharmacies are uniquely positioned to play a key role in the implementation of Risk Evaluation and Mitigation Strategies (REMS).
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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
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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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
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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August 18, 2009 By:Formulary journal staff
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) has prematurely terminated a trial of sildenafil for the treatment of pulmonary arterial hypertension (PAH) in adult patients with sickle cell disease because of safety concerns.
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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
Initiation of antipsychotic therapy associated with hyperglycemia in older diabetic patients
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July 1, 2009 By:Formulary journal staff
A matched, case-control analysis demonstrated an association between the use of stimulant medications (used to treat attention-deficit/hyperactivity disorder [ADHD]) and sudden unexplained death in children and adolescents.
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