Posts Tagged: FDA

Binosto – A New Formulation of Alendronate is Now Available

Binosto effervescent tablet from Effrx

Alendronate is the most common medicine prescribed for the treatment of osteoporosis in the United States. Alendronate is a generic medicine made by various manufacturers in a tablet form. Now alendronate is available in an effervescent tablet called Binosto. Think Alka-Seltzer. Drop Binosto in room temperature water, it fizzes up and is in solution ready to drink after a quick stir.

New Medicine Option for Men with Osteoporosis Approved

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The FDA approved a new indication for the use of the osteoporosis medicine, Prolia® (denosumab): “Treatment to increase bone mass in men with osteoporosis at high risk for fracture.”

With this approval five osteoporosis medicines are approved for use in men: Fosamax® (alendronate), Actonel® (risedronate), Reclast® (zoledronic acid), Forteo® (teriparatide), and Prolia® (denosumab).

Calcitonin in the firing line… linked to increased risk of cancer

News from the European Medicine Agency A committee of the European Medicine Agency, the Europe equivalent of the US Food and Drug Administration (FDA), investigated calcitonin and cancer risk. The committee’s evaluation and recommendation for action by the agency was released July 20, 2012. Note in the US, the brand names for calcitonin used in… Read more

FDA Issues New Safety Alert for Miacalcin (Calcitonin)

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FDA Center for Drug Evaluation and Research (CDER) issued a new safety labeling change for Miacalcin (Calcitonin-Salmon) Nasal Spray and Injection. Tremors were added as an adverse reaction. The accompanying product information that you receive with your prescription will have the following addition: ADVERSE REACTIONS Dermatologic/Hypersensitivity Central and Peripheral Nervous System: Tremor Source:   

Are Medicines That Should Prevent Fractures Causing Fractures?

Atypical femur fracture X-ray

Research Article: Bisphosphonates and Fractures of the Subtrochanteric or Diaphyseal Femur Dennis M. Black, et al for the Fracture Intervention Trial and HORIZON Pivotal Fracture Trial Steering Committees. New England Journal of Medicine. 2010 May 13;362(19):1761-71. Epub 2010 Mar 24. Background. Bisphosphonates are a class of drugs commonly prescribed for patients who have osteoporosis and… Read more