PALO ALTO, Calif.— Affymax Inc. and Takeda Pharmaceuticals are voluntarily recalling all lots of the anemia drug Omontys after reports of fatalities and anaphylaxis, a life-threatening allergic reaction.
The U.S. Food and Drug Administration (FDA) said health care providers should stop using Omontys and return the product to Takeda.
Affymax and Takeda are investigating these adverse reactions. Customers can call 1-855-466-6689 for additional information.
In March 2012, the FDA approved Omontys (peginesatide)for those patients with kidney failure on dialysis. The current recall comes after officials received 19 reports of anaphylaxis from dialysis centers throughout the U.S., according to the FDA.
Three of the anaphylaxis cases resulted in death. Other patients required prompt medical intervention and in some cases hospitalization, according to the FDA. Some of the reports included patients who were able to be resuscitated by doctors.
As of Sunday, February 24, fatal anaphylactic reactions have occurred in 0.02 percent of patients who have taken the drug—more than 25,000 patients have already received the new anemia drug.
Bloomberg reported an 85 percent decline in Affymax's stock price after the recall. The latest stock prices hit a $2.62 low.
“Due to the severity of the public health risk, we want to be certain that health care providers stop using Omontys,” said Howard Sklamberg, director, Office of Compliance, FDA’s Center for Drug Evaluation and Research. “Americans deserve medications that are safe, effective, and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more.”
More information will be available as the investigation continues. Representatives from Affymax/Takeda have been contacted for comment.