Cory Watson Attorneys investigated reports of fatal or life-threatening injuries associated with Omontys®, an injectable drug used to treat anemia in dialysis patients. On February 23, 2013, Affymax, Inc. and Takeda Pharmaceutical Company announced a voluntary recall of all lots of Omontys (peginesatide).
The recall follows post-marketing reports regarding serious and potentially fatal hypersensitivity and allergic reactions, including anaphylaxis. In addition to recalling all lots of Omontys on the market, the drug makers have instructed health care professionals to not provide it for any new patients.
Omontys® Anaphylaxis Risk
Following 19 reports of anaphylaxis from dialysis centers in the United States, the U.S. Food and Drug Administration (FDA) alerted health care providers about the recall, and warned that all Omontys treatment should be immediately stopped.
“Due to the severity of the public health risk, we want to be certain that health care providers stop using Omontys,” said Howard Sklamberg, who heads the compliance office at the FDA’s Center for Drug Evaluation and Research.
To date, fatal reactions have been reported in patients following the first dose of intravenous administration. The reported serious hypersensitivity, allergic reactions, and anaphylactic shock have occurred within 30 minutes after such administration of Omontys.
Omontys® Recall Information
Omontys (peginesatide) is indicated for the treatment of anemia due to chronic kidney disease in adult dialysis patients and is packaged in 10mg and 20mg multi-dose vials:
- 10mg Multi-Dose Vials – NDC 64764-610-10
- 20mg Multi-Dose vials – NDC 64764-620-20
All lots of Omontys are affected by this recall:
- 10mg Multi-Dose vials – Lots C18685, C18881, C19258
- 20mg Multi-Dose vials – Lots C18686, C18696
The product can be identified by its product labeling featuring the name Omontys. The recalled drugs were distributed throughout the United States, including Puerto Rico and Guam, to dialysis centers via specialty distributors.
*Cory Watson Attorneys is no longer accepting Omontys Allergic Reaction cases.
Omontys® is a registered trademark of Affymax, Inc. and Takeda Pharmaceuticals and is used here only for the purpose of identifying the product in question.
This law firm is not associated with, sponsored by, or affiliated with the U.S. Food and Drug Administration, Affymax, Inc. or Takeda Pharmaceuticals.