Fresenius Dialysis Clinics Decided To Stop Using Omontys Before FDA Warning Came Out Due To Five Adverse Event Reports From One Day In February 2013
(Posted by Tom Lamb at DrugInjuryWatch.com)
The Omontys (peginesatide) injection had been used in more than 25,000 patients since it was approved by the FDA in March 2012 to treat kidney dialysis patients for anemia stemming from chronic kidney disease. Omontys was generally more convenient than other anemia drugs in that it can be infused once month, while other anemia drugs generally are given a dozen or more times a month.
Less than a year after Omontys was FDA-approved, however, all lots of this apparently unsafe drug were recalled by its manufacturer, Affymax Inc., as we reported in this article, "Kidney Dialysis Anemia Drug Recall: Omontys: Hypersensitivity / Allergic Reactions And Anaphylaxis; Serious Side Effects With Some Being Fatal".
Now, a new Wall Street Journal (WSJ) piece by reporter Thomas M. Burton provides some interesting background information about the Omontys safety signals that started to emerge back in August 2012 and were finally detected in February 2013.
Strictly Confidential, No Obligation.
From this March 29, 2012 WSJ news report, "Anemia Drug Had Early Side Effects":
A total of 98 "adverse events" tied to the drug were reported to the FDA by Feb. 22 of this year, the day before the recall. There were 12 deaths among the reports to the FDA, but the cause of death wasn't specified, and the patients getting dialysis and Omontys are by definition already very sick. Takeda said there were five deaths that the companies considered in deciding to recall Omontys lots on Feb. 23....
Fresenius Medical Care AG, which operates 1,800 dialysis facilities in the U.S., said it has used Omontys in over 18,000 patients.
It said that shortly after it expanded use of the drug in February, on Feb. 11 "five adverse event reports of allergic type reactions were received," according to a company spokesman. Soon after, Fresenius decided to "pause" in its use of Omontys, the spokesman said.
We are currently investigating what appears to be one of those February 11, 2013 adverse events at a Fresenius dialysis clinic. Our case involves a woman in Florida who suffered a life-threatening anaphylactic reaction for which she was hospitalized three days.
Generally, anaphylactic reactions, or anaphylaxis, are acute allergic reactions in which the patient's airway constricts making it a struggle to breathe, with blood pressure plummeting and the heart beating erratically such that it might not be able to pump enough blood.
According to the March 2013 WSJ article about Omontys, the FDA is currently "evaluating various factors" in its determination about whether Omontys will be sold again, or not, in the U.S.
We are actively monitoring the Omontys recall situation and investigating possible products liability lawsuits for serious side effects involving hypersensitivity reactions such as anaphylaxis, which can be fatal and result in the patient's death.______________________________________________________________________________