Sellers of the anemia drug Omontys (peginesatide) have issued a recall of their product less than one year after it was approved by the Food and Drug Administration (FDA) because it may cause severe or fatal hypersensitivity reactions. Here’s what you should know about Omontys.
What is Omontys?
Both Affymax and Takeda, the two companies selling Omontys, issued a statement saying “No new or existing patients should receive Omontys.” All practitioners, clinics, and patients are being notified to stop product use and being offered information on how to return the drug.
But what is Omontys? Peginesatide is prescribed for adults on hemodialysis with anemia (low red blood cell levels) associated with chronic kidney disease. The injectable drug belongs to a category known as synthetic erythropoiesis stimulating agents (ESAs), which also includes epoetin alfa (Epogen, Procrit) and darbepoetin alfa (Aranesp).
ESAs are sometimes prescribed for treatment of anemia in people who have chronic kidney failure or who have had chemotherapy or certain treatments for human immunodeficiency virus. The drugs work by stimulating the bone marrow to produce more red blood cells.
The FDA, Affymax, and Takeda have noted that use of Omontys has resulted in fatal anaphylactic reactions in 0.02 percent of the more than 25,000 individuals who have taken the drug since it was approved. These deadly reactions occurred after the first dose of the drug. Overall, about 0.2 percent of users have experienced a severe hypersensitivity reaction.
According to Affymax (the company that discovered the drug), use of Omontys and other ESAs is associated with a list of serious warnings and contraindications. For example:
- Use of Omontys can increase the risk of serious cardiovascular reactions such as stroke, blood clots (venous thromboembolism), and heart attack
- People who have cancer have an increased risk of progression of their tumor or tumor recurrence
- Anyone who has uncontrolled high blood pressure should not take Omontys
- Patients undergoing coronary artery bypass graft surgery have an increased risk of dying
- Individuals undergoing orthopedic procedures have an increased risk of deep venous thrombosis (blood clots that form deep in the body, typically in the leg or thigh)
- The most common adverse reactions include arteriovenous fistula (abnormal blood vessel formation), cough, diarrhea, heartburn, and nausea.
So far, all the serious hypersensitivity reactions have occurred within 30 minutes of patients receiving the drug. No patients have suffered a serious hypersensitivity reaction after taking subsequent doses.
In the warning letter about Omontys to healthcare providers, Affymax and Takeda note that anyone who has already received Omontys and who displayed hypersensitivity reactions may respond to antihistamines, corticosteroids, epinephrine, and/or intravenous fluids.
The letter also urges providers to report any suspected adverse events associated with Omontys use to Affymax (855-466-6689, 9AM to 5PM Eastern time, Monday through Friday) or to the FDA’s MedWatch Adverse Event Reporting program.
If you or a loved one has used Omontys, be sure to talk to your healthcare provider and follow her instructions. Recall of the anemia drug Omontys will likely result in a change in your treatment program.
Food and Drug Administration
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