The Omontys (peginesatide) Injection is a drug used to treat anemia in chronic kidney disease patients. It has been voluntarily recalled by its manufacturer after it caused anaphylaxis in several patients who received the intravenous drug. Three of these patients died.
Anaphylaxis, or anaphylactic shock, is a life-threatening, whole-body allergic reaction to a chemical.
Omontys is used to treat anemia in adult kidney dialysis patients. It is manufactured by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfield, Ill. The product is distributed nationwide.
Affymax and Takeda voluntarily recalled their product in February 2013.
All outstanding lots of Omontys are affected by the recall, including:
- 10mg Multi-dose Vials – NDC 64764-610-10 Lots C18685, C18881, C19258
- 20mg Multi-dose vials – NDC 64764-620-20 Lots C18686, C18696.
Health care providers should stop using Omontys and return the product to Takeda Pharmaceuticals, the U.S. Food and Drug Administration (FDA) says in an alert distributed to dialysis clinics and other healthcare providers.
Dangerous Hypersensitivity to Anemia Drug Omontys
Chronic kidney disease patients who must undergo dialysis are susceptible to anemia. This is an iron deficiency in the blood. Iron-poor blood does not carry enough oxygen to the body. Intravenous injections of peginesatide are used to stimulate the formation of red blood cells in dialysis patients.
Omontys (peginesatide) Injection was approved by the FDA in March 2012.
However, Affymax, Inc., the manufacturer of Omontys Injection, has received reports of serious hypersensitivity reactions to an initial administration of the drug, including anaphylaxis, an emergency condition that requires professional medical attention right away.
Symptoms can develop quickly, often within seconds or minutes.
Among the most serious are:
- Abnormal heart rhythm (arrhythmia)
- Fluid in the lungs (pulmonary edema)
- Rapid pulse
- Difficulty breathing
- Difficulty swallowing
- Chest discomfort or tightness
- Swelling of the face, eyes, or tongue
- Mental confusion
In addition, all erythropoiesis-stimulating agents, which aid in the formation of red blood cells, increase the risk of myocardial infarction (heart attack), stroke and thromboembolism (blood clots), all of which are potentially deadly.
The FDA says Affymax has notified the agency of 19 reports of anaphylaxis in patients receiving the Omontys anemia drug at dialysis centers in the U.S. Three of the Omontys-induced anaphylaxis cases resulted in death. Other patients required prompt medical intervention. Some were hospitalized.
Dialysis clinics were instructed to discontinue use of Omontys, the FDA says.
Contact an Omontys Anemia Drug Recall Lawyer
The recall of the Omontys (peginesatide) Injection anemia drug will ensure that additional patients do not receive this potentially dangerous pharmaceutical product. But it does not help dialysis patients who have already been harmed because they were administered Omontys.
If you or a loved one received Omontys as a part of kidney dialysis treatment and suffered a severe adverse reaction, you should act immediately to protect your rights. An experienced attorney can explain your legal options.
Call our toll-free number or complete our online contact form to schedule a consultation with The Driscoll Firm, LLC You may be eligible to receive compensation for medical expenses and other losses as well as for your pain and suffering.
For more information:
- Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of Omontys (peginesatide) Injection, U.S. Food and Drug Administration
- Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots – Serious Hypersensitivity Reactions, U.S. Food and Drug Administration
- FDA alerts health care providers of recall of anemia drug Omontys
- Anaphylaxis, U.S. Food and Drug Administration
- Anemia, MedLine Plus, National Institutes of Health