In February 2012, the FDA recalled Omontys and warned that approximately 2 out of 1,000 people suffer allergic reactions — about 1/3 of them were serious. There have also been 3 reports of death.
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?
The intravenous (IV) medication Omontys (peginesatide) is used to treat anemia (low red blood cell count). It is approved to treat anemia in patients with end-stage kidney failure who are undergoing hemodialysis (mechanical cleaning of their blood). Omontys is manufactured by Affymax Inc. and Takeda Pharmaceutical Company. It was approved by the FDA in March 2012.
Omontys Lawsuit
You have a limited amount of time to file an Omontys lawsuit, and the rules are different for every state. Once this deadline passes, you may have limited options for seeking compensation for your injuries. Individuals and families who have been injured by Omontys should contact an Omontys lawyer immediately — do not wait.
If you file an Omontys lawsuit, you could receive compensation for:
- Pain and suffering
- Medical expenses
- Lost income
- Decreased quality of life
- Disability (permanent injuries)
- Wrongful death of your loved one
- And more
Omontys Safety Risks
Unfortunately, severe and sometimes fatal allergic reactions have been reported in about 0.2% out of 25,000 patients who were treated with Omontys. About one-third of people who have a reaction suffer serious complications and require emergency medical intervention or hospitalization. About 0.02% of people who are treated with Omontys suffer fatal complications.
According to the FDA:
“Some of the reports included patients who were able to be resuscitated by doctors. However, anaphylaxes is life-threatening and resuscitation efforts are not always successful.”
The serious allergic reactions occurred only in patients who were given their first dose of Omontys. They did not occur in patients given subsequent injections of Omontys or those who completed their dialysis treatment session.
Omontys Recall
Omontys was voluntarily recalled on February 23, 2012. The FDA announced the recall in this Drug Safety Communication. In an accompanying news release, the FDA warned:
“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
Omontys has been linked to anaphylaxis, which is a life-threatening whole-body allergic reaction that occurs when the immune system over-reacts to a foreign chemical in the body. It is also known as anaphylactic shock. The most common causes include food allergies, bee stings or insect venom, and medications.
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)
- Shock
- Loss of consciousness
- Low blood pressure
- Hives
- Organ damage (including brain damage)
- Permanent disability
- Death
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