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Drugmaker Affymax and supplier Takeda Pharmaceutical, which jointly market the drug, recently announced a recall of the drug, following reports that the drug had caused severe allergic reactions, including some that proved fatal. The notice is posted by the FDA.
According to the FDA, it has received 19 reports of anaphylaxis — a severe all body allergic reaction. Three of the patients have died, while others required immediate medical intervention or hospitalization.
Omontys is used for the treatment of anemia due to chronic kidney disease in adult patients on dialysis and is packaged in 10 mg and 20 mg Multi-dose vials. The move affects thousands of kidney-disease patients who have been treated with the new drug, promoted as a less expensive alternative to Epogen,
Affymax and Takeda said that hypersensitivity reactions have been fatal in 0.02 percent of the roughly 25,000 patients treated with Omontys since its approval less than a year ago. Over all, the companies said, about 2 of every 1,000 patients had a hypersensitivity reaction.
The companies and the FDA said the reactions occurred within 30 minutes of patients receiving their first dose by intravenous administration.
The product can be identified by its product labeling featuring the name Omontys, distributed Nationwide, including Puerto Rico and Guam, to dialysis centers via specialty distributors.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program.