TOKYO/WASHINGTON Feb 24 U.S.-based Affymax Inc
and Japan's Takeda Pharmaceutical Co said they
are voluntarily recalling all lots of anemia treatment Omontys
(peginesatide) in the United States due to reports of serious
hypersensitivity reactions, including some deaths.
As of Sunday, fatal reactions to the injection have been
reported in about 0.02 percent of 25,000 patients after
receiving their initial injection of the treatment, Affymax said
in a statement.
The drug is used to treat anemia in adult dialysis patients,
and has resulted in reports of serious allergic reactions known
as anaphylaxis in some recipients.
The U.S. Food and Drug Administration on Sunday alerted
healthcare providers about the recall, and said it had received
19 reports of anaphylaxis from dialysis centers in the United
"Due to the severity of the public health risk, we want to
be certain that healthcare providers stop using Omontys," said
Howard Sklamberg, who heads the compliance office at the FDA's
Center for Drug Evaluation and Research.
Sklamberg said the agency is investigating the products and
facilities related to the recall and will provide updates once
it receives more information.