Medication Safety - Formulary

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Medication Safety

Specialty pharmacy's role in REMS, FDA's new drug safety program

October 1, 2009

Specialty pharmacies are uniquely positioned to play a key role in the implementation of Risk Evaluation and Mitigation Strategies (REMS).

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.

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.

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).

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).

Trial of sildenafil for PAH in patients with sickle cell disease terminated because of safety concerns

August 18, 2009

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.

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.

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

ADHD medications may be linked to sudden unexplained death

July 1, 2009

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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