NSAID utilization patterns following market withdrawal of rofecoxib
July 1st 2005Cyclooxygenase-2 (COX-2)-selective nonsteroidal anti-inflammatory drugs (NSAIDs) have been widely prescribed for patients with arthritis and other conditions because of their lower risk for gastrointestinal adverse events compared with nonselective NSAIDs 1,2
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Dapoxetine: A novel, fast-acting serotonin reuptake inhibitor
July 1st 2005Dapoxetine (Alza/Ortho-McNeil) is a novel oral medication undergoing FDA review for premature ejaculation, one of the most common disorders of sexual dysfunction in men. Dapoxetine is a fast-acting inhibitor of the serotonin reuptake transporter. It has a short half-life and is structurally related to the antidepressant fluoxetine, allowing for on-demand dosing.
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Cost analysis of combination vs single dosage lipid-lowering
July 1st 2005A study was conducted to determine the cost and patient adher- ence rates of lipid-lowering therapy with an extended-release niacin and lovastatin (ERNL) combination agent versus a separate extended-release niacin and statin (ERN-S) combination or statin monotherapy.
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Trends in utilization of alternative analgesics after rofecoxib withdrawal
July 1st 2005The objective of this study was to track the utilization of anti-inflammatory drugs among patients with active rofecoxib prescriptions at the time of market withdrawal through retrospective analysis of pharmacy records and to assess the need for COX-2 inhibitor therapy due to gastrointestinal risk factors.
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Alvimopan: A peripherally selective opioid mu receptor antagonist
June 1st 2005Post-operative ileus causes significant patient morbidity and is a major contributor to patient discomfort and increased length of hospitalization post-operatively. Alvimopan (Entereg, Adolor/GlaxoSmithKline), a peripherally selective opioid mu receptor antagonist with gastrointestinal (GI) tract-specific activity, is undergoing FDA review for the treatment of post-operative ileus.
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Medicare appeals process gets overhaul
June 1st 2005Providers may want to be aware of changes published by the Center for Medicare and Medicaid Services (CMS) that substantially overhaul the appeals process, in part, to reduce the time frames for adjudicating fee-for-service Medicare claims appeals. A process that now exceeds 1,000 days must be reduced to 300 days.
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New board to improve internal oversight, consumer communication of drug safety issues
May 1st 2005The new independent Drug Safety Oversight Board (DSB) within CDER will employ a two-pronged approach to create "a new culture of openness, improved oversight, and enhanced independence," according to FDA officials.
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