In February 2013, an Omontys recall was issued following reports of severe and sometimes fatal reactions caused by side effects of the anemia drug given to patients following dialysis treatment.
STATUS OF OMONTYS LAWSUITS: Following the decision to remove the medication from the market, lawyers are evaluating the potential for Omontys recall lawsuits as a result of the drug makers failure to adequately warn about the risk of anaphylaxis reactions and other problems from Omontys.
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MANUFACTURER: Affymax and Takeda Pharmaceuticals
OVERVIEW: Omontys (peginesatide) was approved in 2012 for treatment of anemia in dialysis patients. It is designed to be injected once per month, but it was not indicated or recommended for individuals with chronic kidney disease who were not on dialysis, or as a general treatment for anemia. It was also never shown to improve symptoms, physical functioning or health-related qualify of life.
An estimated 25,000 patients were treated with the medication, most of which came through a pilot program at a number of Fresenius dialysis centers.
OMONTYS RECALL In February 2013, the manufacturers recalled Omontys following reports of serious hypersensitivity reactions, including several severe and even fatal events.
At least 19 patients who received the drug through the pilot program suffered severe reactions to Omontys, resulting in the need for immediate medical treatment and often hospitalization. In at least three of those cases, patients died following Omontys use.
According to information released by the manufacturer, the Omontys allergic reactions appear to occur within 30 minutes of the first injection in about 0.2% of cases, with about a third of those being serious and sometimes including anaphylaxis. Fatal reactions may occur in about 0.02% of all cases, according to the manufacturers.
It is unclear how many of the actual Omontys problems were properly reported and documented, as side effects and adverse events caused by prescription medications are typically only reported in about 1% to 10% of all cases.
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