By Sarah Mirando  |  March 18, 2013

Category: Legal News
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Dialysis Patients Face Second Dangerous Drug Recall

By Kimberly Mirando

 

Omontys recall lawsuitKidney dialysis patients continue to be plagued with drug recalls affecting medications that are supposed to help them get better but are instead causing serious and sometime fatal side effects. The latest recall affects the anemia drug Omontys (peginesatide), given to hemodialysis patients who have developed anemia from chronic kidney disease.

The Omontys recall comes nearly a year after the FDA issued a Class I recall of the dialysis concentrates GranuFlo and NaturaLyte. The concentrates have been linked to hundreds of deaths due to cardiopulmonary arrest, heart attack, metabolic alkalosis and other side effects. Numerous wrongful death lawsuits have been launched against drugmaker Fresenius Medical Care, and dialysis patients are invited to participate in a class action lawsuit investigation into FMC’s alleged improper actions preceding the GranuFlo/NaturaLyte recall.

The FDA notified kidney dialysis patients and clinics of a second product recall on February 24, 2013. Drugmakers Affymax and Takeda announced they were voluntarily recalling all lots of Omontys (peginesatide) Injection due to reports of serious hypersensitivity reactions in some users. At the time, there were 19 reports of anaphylaxis from U.S. dialysis centers, three of which resulted in death. Some patients were able to be resuscitated by doctors, the FDA said.

More than 25,000 anemic dialysis patients received injections of Omontys since it was released on the market last year. According to the FDA, approximately 0.2% of these patients have reported having a hypersensitivity reaction to the drug, with approximately a third of these being serious in nature.


If you or someone you know received an intravenous dialysis anemia medication and experienced any of the following side effects, you may have been administered Omontys and could be eligible to participate in a class action lawsuit investigation:

  • Rapid, weak pulse
  • Skin rash
  • Hives
  • Flushed or pale skin
  • Nausea
  • Vomiting
  • Diarrhea
  • Throat or tongue swelling
  • Anaphylaxis
  • Heart Attack
  • Stroke
  • Metabolic Alkalosis
  • Low Blood Pressure
  • Cardiopulmonary Arrest
  • Cardiac Arrhythmia


Submit your information for a free legal review at the Omontys Recall Class Action Lawsuit Investigation. Compensation Specialist will review your claims for free. If you have a case, you’ll be guided through the process of seeking compensation for your injuries. The attorneys working this investigation do not get paid unless you do, so there is no out-of-pocket cost to participate. Submit your information now!


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Updated March 18th, 2013

 

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