Waxahachie, TX (Law Firm Newswire) May 6, 2013 - The FDA has issued a recall for anemia drug Omontys.
Omontys has been recalled by the U.S. Food and Drug Administration (FDA). Doctors and their patients have indicated that some individuals have experienced a life-threatening and serious allergic reaction to Omontys after receiving an injection. Anaphylaxis causes breathing passages to swell shut, among other things. It requires immediate medical intervention to prevent death.
An artificial protein, Omontys is used to treat anemic adults undergoing dialysis. Omontys, made and distributed by two Big Pharma companies, Affymax, Inc. and Takeda Pharmaceuticals, was designed to assist in the stimulation of red blood cell production in dialysis patients with anemia due to kidney failure ,or after drugs have destroyed the body's red cell count.
"Any incidences of an adverse reaction should be immediately reported to the FDA," commented Waxahachie personal injury attorney John Hale.
The voluntary recall comes smartly on the heels of the new medication's launch; released back in early 2012. Since the drug’s release date, close to 25,000 patients have received Omontys to assist their bodies in dealing with anemia. There are an estimated 50 individuals that have indicated a hypersensitivity to the medication.
The FDA has received 19 adverse event reports from dialysis centers across the nation, citing anaphylaxic shock reactions of those receiving this drug. Of the 19 individuals requiring emergency medical treatment to save their lives, three so far have died. The fatal and near-fatal reactions occurred within the first 30 minutes of receiving the first dose of the medication. The adverse event reports do not make it clear whether or not subsequent doses of Omontys caused similar reactions, or if there were other issues involved after dialysis sessions. It is hoped more answers will be provided as a result of an investigation.
The FDA and both drug manufacturers are now investigating to determine the cause of the adverse drug reactions with an eye to ascertaining if it will be permanently taken off the market. An advisory has been issued to all medical care providers to stop administering Omontys and return any left over, unused product during the investigation. All lots of Omontys are included in the recall.
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