(Posted by Tom Lamb at DrugInjuryWatch.com )The Omontys (peginesatide) procedure was approved in March 2012 to treat adult patients on hemodialysis with anemia arising from chronic kidney disease. Omontys is among the artificial erythropoiesis-stimulating brokers (ESAs). It is given by injection and sold in 10- and 20-mg multidose vials.A Takeda Pharmaceutical Co. and Affymax Inc. Would be the responsible drug companies. A February 24, 2013 New York Times article, "Anemia Drug Is Recalled After Allergic Reactions", by writer Andrew Pollack, provides a concise yet useful statement of the new and still rising medicine protection issue: The F.D.A. said in a release on Sunday that it had received 19 reports of anaphylaxis, a severe hypersensitive reaction, and that three of the patients had died, although some required immediate medical intervention or hospitalization.... Affymax and Takeda stated that hypersensitivity reactions have now been critical in 0.02 percent of the roughly 25,000 patients treated with Omontys since its approval. That will suggest there has been five deaths, a small difference from the F.D.A. Results that was not defined. Over-all, the firms said, about 2 of each and every 1000 people had a hypersensitivity reaction. The firms and the F.D.A. said the reactions occurred within thirty minutes of patients receiving their first dose by intravenous administration. No problems have already been reported with subsequent doses, which are given once per month. Still, the businesses and the F.D.A. Recommended that Omontys use be discontinued even by people who've already had more than one dose.... Dr. Daniel W. Coyne, a professional at Washington University in St. Louis, said that unless the situation was as a result of contamination, athis might easily cause withdrawal of drug approval.a He said that atwo in 10,000 deaths on first exposure is unacceptable, compared to nothing beats thisa with Epogen. Here are links for some of the source material recommended above: That February 24, 2013 post, "Fatal Reactions Prompt Omontys Recall", published on line 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 promoted the drug by a vote, with one member abstaining. During that meeting, screen chair Wyndham Wilson, MD, PhD, chief of the lymphoma department at the National Cancer Institute in Bethesda, Md., said it appeared that [Omontys (peginesatide )] "doesn't have any protection signals." Some 2,600 people had participated in the drug's phase III studies, about half of these assigned to [Omontys (peginesatide )]. The lone "no" vote was cast by steve Nissen, MD, of the Cleveland Clinic, at the advisory board meeting. He'd cited the lack of blinding in the studies as his rationale for opposing agreement. We are reviewing Omontys cases involving severe and often dangerous undesirable hypersensitivity reactions, including anaphylaxis, as you can drug damage lawsuits against Takeda and Affymax.A Free Case Evaluation Needless to say, we will be observing to see whether these reported fatalities and allergic reactions will trigger Omontys to be removed from the marketplace. DrugInjuryLaw.com: Appropriate Information And Information About Prescription Drug Area EffectsA (All website material by attorney Mary Lamb) Drug Damage Case Analysis - Free & ConfidentialA (Evaluation done by attorney Jeff Lamb)
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