On Sunday, February 23, 2013, Affymax and Takeda Pharmaceuticals recalled all lots of Omontys, a drug they developed to treat anemia in patients undergoing kidney dialysis.
The companies recalled their product after reports evidenced that Omontys may cause severe and sometimes fatal allergic reactions.
What is Omontys?
Omontys (generic name: peginesatide) was introduced in March 2012 as a treatment for anemia in dialysis clinics. It is marketed as “the only once-monthly erythropoiesis stimulating agent (ESA) for anemia available to the dialysis patient population in the U.S.” The drug was discovered by Affymax, and has been co-developed and marketed by Affymax and Takeda.
Serious Adverse Effects
To date, there have been reports of at least 19 cases of anaphylaxis from U.S. dialysis centers. These include three cases which resulted in death, the FDA said. The FDA has been alerting health-care providers and patients of the voluntary recall, and that anaphylaxis is a “serious and life-threatening” allergic reaction to the drug. Over all, the companies said, about 2 of every 1,000 patients had a hypersensitivity reaction.
Earlier in February 2013, Fresenius Medical Care North America, the nation’s largest dialysis provider and manufacturer of Granuflo and Naturalyte (which are currently the subject of litigation due to reports of increased risks of heart attacks and related deaths), halted a pilot program testing Omontys in their clinics. Frenesius stated in a memorandum that it had treated 18,000 patients with the drug and it planned to analyze the data. It has not been reported how many of those FMC patients suffered from anaphylaxis. The most troubling aspect is that these deaths apparently occur on first use of the drug.
Initial reports suggest that some patients suffered “serious and fatal” hypersensitivity within 30 minutes of receiving their first Omontys dose by intravenous injection. The FDA stated that the risk did not appear to occur in subsequent doses, nor did patients who have finished their dialysis session seem to be at risk. Regardless, Takeda, Affymax and the F.D.A. advised that Omontys use be discontinued even by patients who have already had more than one dose.
The Future of Omontys
It is not known if the Omontys recall is permanent or temporary. It has only been on the market for approximately 9 months, with sales reaching $34.6 million. There is speculation that Takeda and Affymax may lose approval for the drug. Alternatively, the companies may be required to invest in huge studies to prove the drug’s safety prior to restarting sales. It is expected that people suffering from a serious Omontys allergic reaction (including Omontys anaphylaxis) will seek to redress their rights through Omontys lawsuits.
Do I have an Omontys Lawsuit?
Slater Slater Schulman LLP is dedicated to the representation of plaintiffs in Omontys lawsuits. Our firm is handling Omontys litigation related to these injuries nationwide.
If you or someone you love has suffered a severe allergic reaction after taking Omontys, you should discuss your legal rights with an Omontys lawyer. Contact Slater Slater Schulman LLP today for a free consultation by filling out the form on this page or by calling us at (800) 251-6990.
Medical disclaimer: Please note that any change in medications should be made only after consulting with your doctor about the risks and benefits of doing so, and should not be based on any information contained in this web site.