Takeda and Affymax announced the voluntary recall of Omontys (peginesatide) in the US following reports of serious hypersensitivity reactions, some of which have been fatal. The recall, which affects all lots of the injectable therapy, is being conducted in agreement with the FDA.
According to the companies, fatal reactions have been reported in approximately 0.02 percent of patients within the first 30 minutes of receiving the first dose of the therapy intravenously. There are no reports of such reactions following subsequent dosing or in patients who have completed their dialysis session. The companies added that they are actively investigating these cases.
Dialysis organisations have been instructed to discontinue use of the therapy, which was approved in the US last year as a treatment for anaemia due to chronic kidney disease in adults on dialysis. Takeda and Affymax have also issued a letter requesting that healthcare professionals do not prescribe the injectable to any new or existing patients.
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