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Weekly Drug News Round Up - May 15, 2013

Lower Zolpidem Doses Needed Due to Next Morning Impairment

Women appear to be more susceptible to this risk than men because they eliminate the drug more slowly Read More...

The U.S. Food and Drug Administration (FDA) is notifying the public of new information about zolpidem, a widely prescribed sleep medication. FDA recommends that the bedtime dose be lowered because blood levels may be high enough the next morning to impair activities that require alertness, such as driving. The recommended dose of zolpidem for women should be lowered from 10 milligrams to 5 milligrams for immediate-release products (Ambien, Edluar, Zolpimist and generics) and from 12.5 mg to 6.25 mg for extended-release (ER) products (Ambien CR and generics). Data show the risk for next-morning impairment is highest for patients taking the ER forms of these drugs. In all patients, the lowest effective dose should be prescribed.

FDA Approves Xofigo for Advanced Prostate Cancer

An estimated 238,590 men will be diagnosed with prostate cancer and 29,720 will die from the disease in 2013 Read More...

The U.S. Food and Drug Administration (FDA) has approved Xofigo (radium Ra 223 dichloride) to treat men with late-stage, castration-resistant prostate cancer that has spread to the bones but not to other organs. Xofigo was evaluated in a single clinical trial of 809 men with symptomatic castration-resistant prostate cancer. The study was designed to measure overall survival. Men receiving Xofigo lived a median of 14 months compared to a median of 11.2 months for men receiving placebo. Xtandi (enzalutamide), approved in August 2012, has also been shown to extend the survival of men with metastatic prostate cancer.

Nymalize Oral Solution Approved for Subarachnoid Hemorrhage

Nimodipine given by the IV route can result in cardiac arrest, severe hypotension, and other cardiac complications Read More...

Nymalize (nimodipine) oral solution has been approved for adult patients with subarachnoid hemorrhage (SAH). Oral nimodipine may be given to patients via a nasogastric tube, but previously there was no oral solution and clinicians had to extract the solution from the oral gel capsule via an oral syringe. This method of extraction resulted in numerous serious medical errors, as clinicians would mistakenly administer the solution intravenously (IV) instead of by the nasogastric tube. Nimodipine is a calcium channel blocker used to widen blood vessels and improve blood flow.

Breo Ellipta: Approved for Chronic Obstructive Pulmonary Disease

Cigarette smoking is the leading cause of COPD and is the third leading cause of death in the United States Read More...

The U.S. Food and Drug Administration (FDA) has approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the once-daily, maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD. Breo Ellipta is a combination of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA). Breo Ellipta decreases inflammation and relaxes airway muscles to improve breathing in COPD, a chronic lung disease that worsens over time.

New Indication Approved for Ilaris

Systemic juvenile idiopathic arthritis affects 5-15 children per 100,000 in the U.S. Read More...

Systemic Juvenile Idiopathic Arthritis (SJIA) is a rare form of childhood arthritis characterized by spiking fever, rash and arthritis that can affect children as young as 2 years old. The U.S. Food and Drug Administration (FDA) has approved a new indication for Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older. Ilaris is the first interleukin-1 beta (IL-1 beta) inhibitor approved for SJIA and the only treatment approved specifically for SJIA that is given as a once-monthly subcutaneous injection.