Omontys: Deaths During Initial Injection Within 30 Minutes During Treatment Of Anemia Due To Chronic Kidney Disease In Hemodialysis Patients
(Posted by Tom Lamb at DrugInjuryWatch.com)
The Omontys (peginesatide) injection was approved in March 2012 to treat adult patients on hemodialysis with anemia stemming from chronic kidney disease. Omontys is one of the synthetic erythropoiesis-stimulating agents (ESAs). It is given by injection and packaged in 10- and 20-mg multidose vials. Takeda Pharmaceutical Co. and Affymax Inc. are the responsible drug companies.
A February 24, 2013 New York Times article, "Anemia Drug Is Recalled After Allergic Reactions", by reporter Andrew Pollack, provides a concise yet insightful report of this new and still emerging drug safety issue:
The F.D.A. said in a news release on Sunday that it had received 19 reports of anaphylaxis, a severe allergic reaction, and that three of the patients had died, while others required prompt medical intervention or hospitalization....
Affymax and Takeda said that hypersensitivity reactions have been fatal in 0.02 percent of the roughly 25,000 patients treated with Omontys since its approval. That would suggest there have been five deaths, a slight discrepancy from the F.D.A. figures that was not explained. Over all, the companies said, about 2 of every 1,000 patients had a hypersensitivity reaction.
The companies and the F.D.A. said the reactions occurred within 30 minutes of patients receiving their first dose by intravenous administration. No problems have been reported with subsequent doses, which are given once a month. Still, the companies and the F.D.A. advised that Omontys use be discontinued even by patients who have already had more than one dose....
Dr. Daniel W. Coyne, a kidney specialist at Washington University in St. Louis, said that unless the problem was because of contamination, “this could easily lead to withdrawal of drug approval.” He said that “two in 10,000 deaths on first exposure is unacceptable, compared to nothing like this” with Epogen.
Here are links to some of the source material referenced above:
- Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots - Serious Hypersensitivity Reactions [February 23, 2013 FDA MedWatch Safety Information]
- Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of OMONTYS® (peginesatide) Injection [February 23, 2013 Press Release from drug companies]
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This February 24, 2013 article, "Fatal Reactions Prompt Omontys Recall", published online by MedPage Today, gives some interesting background information about the FDA approval of Omontys:
The drug was approved by the FDA in March 2012 after an advisory panel had endorsed the drug by a 15-1 vote, with one member abstaining.
During that meeting, panel chair Wyndham Wilson, MD, PhD, chief of the lymphoma division at the National Cancer Institute in Bethesda, Md., said it appeared that [Omontys (peginesatide)] "doesn't have any safety signals."
Some 2,600 patients had participated in the drug's phase III trials, about half of them assigned to [Omontys (peginesatide)].
Steve Nissen, MD, of the Cleveland Clinic, cast the lone "no" vote at the advisory committee meeting. He had cited the lack of blinding in the trials as his rationale for opposing approval.
We are reviewing Omontys cases involving serious and sometimes fatal adverse hypersensitivity reactions, including anaphylaxis, as possible drug injury lawsuits against Takeda and Affymax. Free Case Evaluation
Of course, we will be watching to see whether these reported allergic reactions and deaths will cause Omontys to be withdrawn from the market.______________________________________________________________________________
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