Affymax, Inc. and Takeda Pharmaceutical Company issued a recall for the drug Omontys, also referred to by its generic name peginesatide. Omontys is used to treat anemia in dialysis patients.
The U.S. Food and Drug Administration (FDA) has received 19 reports of anaphylaxis, a severe allergic reaction, from dialysis centers around the U.S. At least three of the incidents resulted in patient deaths. The reactions occurred within 30 minutes of patients receiving their first doses of the drug by intravenous injection. At this time there have been no reports of anaphylaxis in subsequent doses or in patients who have finished their dialysis session.
All shipments of Omontys, sold in 10 milligram and 20 milligram vials, have been recalled. Healthcare professionals have also been advised to stop using the drug.
The FDA approved Omontys for use in the U.S. last March.