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Postmarketing reports show serious hypersensitivity reactions
February 25, 2013
By: Tim Wright
Editor-in-Chief, Contract Pharma
Affymax, Inc. and Takeda Pharmaceutical Co. Ltd. have voluntarily recalled all lots of OMONTYS (peginesatide) Injection as a result of postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis. The companies have been working with the FDA and issued a letter to health care professionals indicating that no new or existing patients should receive OMONTYS, which is indicated for the treatment of anemia due to chronic kidney disease. To date, fatal reactions have be...
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