Overview: Omontys, the injection used to treat anemia in adult dialysis patients, has been recalled due to reports of hypersensitivity reactions, including anaphylaxis and death. The U.S. Food and Drug Administration (FDA) has warned healthcare professionals about the recall yesterday following 19 reports of anaphylaxis from dialysis centers across the country. The Omontys recall was issued by manufacturer Takeda Pharmaceutical and Affymax, Inc.
- Omontys has been recalled due to reports of hypersensitivity reactions; some patients have experienced anaphylaxis and death after using the drug
- According to the FDA, 0.02% of 25,000 patients have suffered a fatal reaction
- Affymax fell 87 % after the recall
Product: Omontys (peginesatide)
Manufacturer: Affymax, Inc. and Takeda Pharmaceutical Company Limited
Side Effects & Complications
- Hypersensitivity reaction
Omontys Recalled Due to Reports of Hypersensitivity Reaction
On Saturday, the FDA announced that all lots of Omontys are being recalled due to postmarketing reports of hypersensitivity reactions. In some cases, patients have suffered from anaphylaxis, which is potentially fatal allergic reaction in which the throat sometimes closes. According to the agency’s safety notification, 0.02 percent of 25,000 patients have had a fatal reaction to the Omontys. The FDA notified healthcare professionals about the recall yesterday, stating that it had received 19 reports of anaphylaxis, Reuters reports. Howard Sklamberg, head of the compliance office at the FDA’s Center for Drug Evaluation and Research, stated that “Due to the severity of the public health risk, we want to be certain that healthcare providers stop using Omontys,”
Omontys is administered intravenously to help treat anemia in patients with chronic kidney disease undergoing dialysis. The reported hypersensitivity reactions occur within 30 minutes after receiving the injection.
Bloomberg reports that after the recall, Affymax fell as much as 87 percent. Previously, the California-based company had gained 61 percent in the past year. On Saturday, shares fell to $2.97 and then to $2.14.