FDA approves REMS for ER, long-acting opioids
July 17th 2012FDA has approved a new risk evaluation and mitigation strategy for extended-release and long-acting opioids that requires that healthcare professionals are educated on how to safely prescribe the drugs and that patients understand how to safely use the drugs.
FDA approves once-daily oral agent for HIV prevention in uninfected adults
July 17th 2012FDA has approved once-daily oral emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead Sciences), in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.
FDA: Single IV dose of ondansetron may cause potentially fatal heart rhythms
July 12th 2012FDA is alerting healthcare professionals to the possibility that a 32-mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) could lead to QT interval prolongation, putting patients at risk for a potentially fatal heart rhythm known as Torsades de Pointes.
FDA: No major safety concerns with compounded hydroxyprogesterone caproate
July 10th 2012FDA recently released the results of an analysis of a limited number of samples of hydroxyprogesterone caproate active pharmaceutical ingredients and compounded hydroxyprogesterone caproate, finding no major safety concerns.
Vitamin D plus calcium and mortality among elderly
July 5th 2012Vitamin D plus calcium supplementation consistently reduced mortality among elderly patients compared with vitamin D supplementation alone, according to a study published online May 17 in the Journal of Clinical Endocrinology and Metabolism.
Study: Older patients often ignore Rx warning labels
July 5th 2012Brightly colored prescription warning labels applied by pharmacies fail to adequately capture the attention of older patients, suggesting that current labeling standards should be reconsidered to make them more effective, according to a study published online June 14 in PLoS ONE.
McKesson's medication adherence network
July 3rd 2012At their recent ideaShare event, McKesson highlighted its Sponsored Clinical Services Network for hundreds of independent retail pharmacy owners and community pharmacists who are focused on increasing their role in healthcare delivery, improving patient outcomes, and finding new reimbursement avenues, the company said in a release.
FDA approves generic version of acne treatment
July 3rd 2012FDA has approved Perrigo Company’s abbreviated new drug application for a generic version of clindamycin phosphate and benzoyl peroxide 1.2%/5% gel (Duac Gel, Stiefel Laboratories), the company recently announced in a statement. The gel is indicated for the topical treatment of inflammatory acne vulgaris.
Combination therapy for youth with type 2 diabetes
June 28th 2012A combination of 2 diabetes drugs, metformin and rosiglitazone (Avandia, GlaxoSmithKline), was more effective in treating youth with recent-onset type 2 diabetes than metformin alone, a study funded by the National Institutes of Health has found.
FDA approves first weight-loss treatment in over a decade
June 28th 2012FDA has approved lorcaserin (Belviq, Arena Pharmaceuticals and Eisai) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients who are overweight or obese and have at least one weight-related comorbid condition. It is the first prescription weight-loss treatment approved by FDA in 13 years.
Certain EDCs linked to allergy risk in kids
June 25th 2012Urinary levels of the antimicrobial endocrine-disrupting compounds triclosan and parabens were significantly associated with allergic sensitization in children ages 6 to 18 years, according to the results of a study published online June 18 in the Journal of Allergy and Clinical Immunology.