Feb. 25, 2013
-- U.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 fatal ”serious hypersensitivity reactions.” http://www.reuters.com/
idUSBRE91N01Y20130224. As of today, February 24, 2013, deaths have been reported in about .02 percent of 25,000 patients after receiving just once injection of the treatment. Omontys is used to treat anemia in adult dialysis patients, but has caused serious allergic reactions known as anaphylaxis in some patients.
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,”
reported Bloomberg. http://www.bloomberg.com/news/2013-02-24/takeda-affymax-r...
Of the 19 reports of anaphylaxis, three cases resulted in death. About one-third of the 0.2 percent of hypersensitivity reactions was serious enough to require medical intervention or hospitalization. Omontys is an erythropoiesis-
stimulating agent, which helps form red blood cells, needed by anemic patients on dialysis. Takeda has been pursuing new drugs to make up for sales declines after its diabetes drug Actos lost patent protection last year and has become embroiled in litigation. Sales of Omontys tripled to $19 million in January, but will suddenly cease.
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/
medwatch-online.htm. Lastly, consult with an experienced attorney Ennis & Ennis P.A. will offer free, nationwide, confidential consultations for patients who have suffered an injury from Omontys by calling toll free 1-800-856-6405 or by going to http://www.ennislaw.com
and completing an online case evaluation form.