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Follow on Google News | Anemia Drug Omontys Recalled After Causing Allergic Reactions And DeathU.S. based Affymax, Inc., and Takeda Pharmaceutical Co., Japan’s biggest drug manufacturer, voluntarily recalled all lots of an anemia treatment for kidney dialysis patients called Omontys after reports of injuries and death.
Today, the U.S. Food and Drug Administration alerted healthcare providers about the recall, indicating it had received 19 reports of anaphylaxis from dialysis centers across the United States. “Due to the severity of the public health risk, we want to be certain that healthcare providers stop using Omontys,” said Howard Sklamberg, who heads the compliance office at the FDA’s center for Drug Evaluation and Research, reports Reuters. Affymax and Takeda issued a warning statement to physicians that all lots of Omontys, which are sold in 10 milligram and 20 milligram vials, have been recalled and healthcare providers should immediately cease administrating the drug. http://omontys.com/ A Takeda spokesperson announced that, “our company is working with the FDA and Affymax and voluntarily recalled Omontys to put patients’ safety first and we will swiftly provide information to patients and health care professionals,” Ennis & Ennis, P.A. recommends that anyone who received Omontys, who is experiencing complications, first seek medical attention. Then file an adverse event report with the FDA at www.accessdata.fda.gov/ End
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