Omontys Side Effects
The Omontys Injection intravenous solution provided to treat anemia in kidney dialysis patients can cause a sudden allergic reaction known as “anaphylaxis,” according to the U.S. Food and Drug Administration (FDA).
In February 2013, the FDA announced the voluntary recall of Omontys (peginesatide) Injection, a product of Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfield, Ill., due to this side effect.
The FDA says it has received 19 reports of anaphylaxis occurring in dialysis patients given Omontys. Three patients died. Others required emergency medical assistance. Some were hospitalized.
Omontys and Anaphylactic Shock
A potential side effect of kidney dialysis is anemia. This is a diminished amount of red blood cells. This condition is also known as “iron-poor blood.” Blood that does not have a proper level of red blood cells does not deliver enough oxygen to the body.
Omontys is the brand name for peginesatide. This is an erythropoiesis-stimulating agent, which means that it helps the body form red blood cells.
The manufacturers of Omontys – Affymax, Inc., and Takeda Pharmaceutical Company Ltd., and the FDA have reported serious allergic reaction in some dialysis patients who have received Omontys.
This type of reaction to a foreign chemical is known as “anaphylaxis” or “anaphylactic shock.” It is a life-threatening, whole-body allergic reaction. For example, people who are allergic to the venom of a bee sting can have an anaphylactic reaction.
Anaphylactic shock occurs quickly. It is a medical emergency. The body’s allergic reaction makes tissues in different parts of the body release histamine and other substances and causes them to become swollen. This can lead to difficulty breathing as airways close off and problems with blood circulation as vessels and veins tighten.
The lack of blood or oxygen for organs and tissues is what sends the body into shock.
The Mayo Clinic says warning signs of anaphylaxis may include:
- Abdominal pain
- Abnormal (high-pitched) breathing sounds
- Chest discomfort or tightness
- Difficulty breathing
- Difficulty swallowing
- Dizziness or light-headedness
- Hives, itchiness
- Nasal congestion
- Nausea or vomiting
- Palpitations (the feeling of a racing or pounding heart)
- Skin redness
- Slurred speech
- Swelling of the face, eyes, or tongue
Symptoms of anaphylactic shock include:
- Abnormal heart rhythm (arrhythmia)
- Fluid in the lungs (pulmonary edema)
- Low blood pressure
- Mental confusion
- Rapid pulse
- Skin that is blue or pale from lack of oxygen
- Swelling in the throat that may be severe enough to block the airway
- Swelling of the eyes or face
If not treated immediately, shock can cause cardiac arrest (heart attack) and/or pulmonary arrest (inability to breathe) – either of which can lead to death.
Contact Our Omontys Anemia Drug Recall Lawyers
No other patient runs the risk of receiving the drug due to the recall of all outstanding lots of the Omontys anemia drug and orders to discontinue its use. However, there may be thousands of patients who have already suffered side effects after being administered the drug.
If you or a loved one received an Omontys intravenous injection during a kidney dialysis session and suffered a severe adverse reaction, contact The Driscoll Firm, LLC We can explain your legal options and how you can protect your rights as a consumer.
Call our toll-free number or complete our online contact form today
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
- Anaphylaxis, MedLine Plus, National Institutes of Health
- Peginesatide (Injection Route), Mayo Clinic