All lots of the anemia drug Omontys (peginesatide) were recalled in February 2013 due to the potential risk of sudden, severe, and sometimes fatal allergic reactions. These reactions occur in about 2 out of 1,000 people, about 1/3 of reactions were serious, and 3 deaths have been reported. The drug manufacturers and the FDA are published a Safety Communication to warn healthcare professionals to stop using Omontys immediately.
UPDATE: Omontys Pays $6.5 Million to Settle Omontys Class Action
July 7, 2014 — Affymax will pay $6.5 million to settle a class action lawsuit that was filed by investors who accused the drug-maker of misleading them about the risks of Omontys (pedinesatide). By the time the recall was issued, the FDA received 98 adverse event reports, including 12 deaths. Click here to read more.
What is Omontys?
Omontys (peginesatide) is an intravenous (IV) drug approved by the U.S. Food and Drug Administration (FDA) in March 2012 to treat anemia (low red blood cell count) in people who undergo dialysis treatment for end-stage kidney failure. It is manufactured by Affymax Inc. and Takeda Pharmaceutical Co.
What is the problem with Omontys?
Severe and sometimes fatal allergic reactions have been reported in some patients who were treated with Omontys. These reactions occurred within 30 minutes of the first dose. According to the FDA:
“The FDA has been notified by Affymax of 19 reports of anaphylaxis from dialysis centers in the United States. Three of the anaphylaxis cases resulted in death. Other patients required prompt medical intervention and in some cases hospitalization. Some of the reports included patients who were able to be resuscitated by doctors. However, anaphylaxis is life-threatening and resuscitation efforts are not always successful.”
The FDA also warned:
- Approximately 25,000 people have been treated with Omontys.
- Overall, 0.2% of patients had an allergic reaction.
- About one-third of allergic reactions were serious, involved anaphylaxis, required emergency medical intervention, or hospitalization.
- Fatal reactions occurred in about 0.02% of patients who were given their first dose of Omontys.
- There are no reports of allergic reaction in patients following subsequent doses, or in patients who completed their dialysis treatment session.
Omontys was officially recalled on February 23, 2013 when the FDA published a Drug Safety Communication, warning:
“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.”
Omontys and Anaphylaxis
Anaphylaxis is a life-threatening allergic reaction that develops within seconds or minutes. It occurs when the entire body reacts after exposure to a certain chemical (bee sting venom, foods, or a medication are common sources of anaphylaxis).
Serious complications of Omontys anaphylaxis include:
- Airway blockage
- Respiratory arrest (no breathing)
- Cardiac arrest (no heartbeat)
- Swelling of the face, eyes, tongue, or throat (angioedema)
- Loss of consciousness
- Low blood pressure
- Organ damage (including brain damage)
- Permanent disability