Injections made by a Texas compounding pharmacy may be responsible for bloodstream infections, says the Food and Drug Administration (FDA).
The reports are the latest in a series of similar incidents that emerged since a fungal meningitis outbreak in September 2012 was tied to steroid injections produced by New England Compounding Center in Massachusetts. More than 60 people died, and 700 were infected by the shots, which were contaminated with a fungus. The cases prompted the FDA to increase pressure on state pharmacy boards, which oversee compounding pharmacies, to ensure they met quality and safety standards, since the FDA’s authority over the pharmacies is limited; state pharmacy boards license compounding pharmacies to produce limited amounts of custom-blended medications — in some cases without ingredients to which patients might be allergic, at a different dosage that is more tolerable for patients, or in a different formulation that patients prefer (liquid v. pill, for example). Some of the ingredients compounding pharmacies use are provided by the manufacturer of the original drug, but some pharmacies source their own active compounds for the medications, which can lower the drugs’ costs.
After 15 patients were hospitalized with blood infections after receiving calcium gluconate injections, the FDA announced a voluntary recall of all sterile products produced and distributed by Specialty Compounding, LLC in Cedar Park, Tex., which made the shots. Calcium gluconate is used to treat heart disease, high potassium levels and calcium deficiencies
Read more: http://healthland.time.com/2013/08/12/more-compounding-pharmacy-products-recalled/#ixzz2bmYBI1uA
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