All lots of the new anemia drug peginesatide (Omontys) have been recalled because of severe hypersensitivity reactions -- some fatal -- observed after the drug was approved last March.
"No new or existing patients should receive Omontys," according to a statement from the two firms selling the drug, Affymax and Takeda. However, they stopped short of saying the product was being withdrawn from the market.
According to the companies and the FDA, fatal anaphylactic reactions have occurred in 0.02% of patients taking the drug. The absolute number of deaths was not stated. More than 25,000 people have received the drug since it was approved, the FDA said.
"The rate of overall severe hypersensitivity reactions reported is approximately 0.2%, with approximately a third of these being serious in nature including anaphylaxis requiring prompt medical intervention and in some cases hospitalization," Affymax and Takeda said in the statement, which was included in the FDA's recall notice.
Peginesatide, a synthetic erythropoiesis stimulating agent, was approved to treat adult patients on hemodialysis with anemia stemming from chronic kidney disease. It is given by injection and packaged in 10- and 20-mg multidose vials.
The FDA recommended that dialysis clinics stop using the product immediately. Takeda and Affymax said they were notifying healthcare professionals and customers of the recall, with instructions on how to return the product.
The drug was approved by the FDA in March 2012 after an advisory panel had endorsed the drug by a 15-1 vote, with one member abstaining.
During that meeting, panel chair Wyndham Wilson, MD, PhD, chief of the lymphoma division at the National Cancer Institute in Bethesda, Md., said it appeared that peginesatide "doesn't have any safety signals."
Some 2,600 patients had participated in the drug's phase III trials, about half of them assigned to peginesatide.
Steve Nissen, MD, of the Cleveland Clinic, cast the lone "no" vote at the advisory committee meeting. He had cited the lack of blinding in the trials as his rationale for opposing approval.