Affymax Inc. (AFFY) fell as much as 87 percent after the company and partner Takeda Pharmaceutical Co. (4502) voluntarily recalled an anemia treatment for kidney dialysis patients after reports of fatal reactions.
All lots of Omontys, sold in 10 milligram and 20 milligram vials, have been recalled and health-care professionals have been told that patients shouldn’t receive the medicine, the companies said in a statement. The U.S. Food and Drug Administration, which approved Omontys in March, agreed to the recall, they said.
“Our company is working with the FDA and Affymax and decided to voluntarily recall Omontys to put patients’ safety first,” said Kazumi Kobayashi, a spokesman for Osaka-based Takeda. “We will swiftly provide information to patients and health-care professionals.”
Affymax’s drug is used to alleviate anemia in kidney dialysis patients, who can suffer from low red blood cell counts. There have been 19 reports of anaphylaxis from U.S. dialysis centers, three of which resulted in death, the FDA said. Some patients were able to be resuscitated by doctors.
The fatal reactions amount to 0.02 percent of some 25,000 patients who have received first-dose injections of Omontys, Takeda and Affymax said in the statement. About 0.2 percent of patients have had reactions that needed medical intervention.
The FDA is alerting health-care providers and patients of the recall, which is due to reports of anaphylaxis, a “serious and life-threatening” allergic reaction, the agency said in a statement yesterday.
“Serious and fatal” hypersensitivity reactions have been reported in some patients within 30 minutes of receiving their first doses of the drug by intravenous injection, the FDA said in the statement. There have been no reports of reactions in subsequent doses or in patients that have finished their dialysis session, the agency said.