Omontys (generic: peginesatide injection), a popular dialysis treatment drug, is being recalled after being linked to adverse hypersensitivity reactions, anaphylaxis, and death. This Omontys recall includes all lots of the drug distributed nationwide (including Puerto Rico and Guam) to dialysis treatment centers via specialty distributors. The Omontys Lawyers at Schmidt & Clark, LLP, are currently accepting potential lawsuits on behalf of individuals who suffered serious side effects or died after being treated with Omontys.
February 23, 2013 – The U.S. Food & Drug Administration (FDA) issued a press release today announcing that Affymax, Inc., and Takeda Pharmaceutical Company have issued a nationwide recall for the following lots of Omontys:
- 10mg Multi-dose Vials – NDC 64764-610-10 Lots C18685, C18881, C19258
- 20mg Multi-dose vials – NDC 64764-620-20 Lots C18686, C18696
Side Effects of Omontys
The Omontys recall was ordered after the injectable dialysis drug was linked to the following serious side effects:
- life-threatening hypersensitivity reactions
According to the FDA, fatal Omontys reactions have been reported in approximately 0.02% of patients receiving their first dose of the drug. These Omontys side effects occurred within 30 minutes of the medication being administered. To date, there have been no reports of such Omontys side effects occurring following subsequent dosing, or in patients who have completed their dialysis session. Since Omontys was first approved in March 2012, more than 25,000 patients have been treated with the drug in the postmarketing setting. The rate of overall Omontys hypersensitivity reactions reported is about 0.02%, with approximately one-third of these being considered serious in nature and requiring emergency medical treatment.
Dialysis organizations have been advised to discontinue use of Omontys immediately. Customers will be provided with instructions on how to return Omontys to the manufacturer for a full refund. Individuals who think they may have an Omontys Lawsuit should contact the law offices of Schmidt & Clark, LLP, today for a free case evaluation to learn more about their legal rights.
Click here to view the Affymax and Takeda Firm Press Release regarding the Omontys recall.