Takeda Pharmaceuticals issued a voluntary nationwide recall of all lots of peginesatide (Omontys) injection, according to an FDA alert issued on February 24. The drug, an erythropoiesis-stimulating agent, has been associated with serious and fatal hypersensitivity reactions, including anaphylaxis, in some patients receiving a first dose.
The reactions, reported to the FDA by 19 US dialysis centers, have occurred within 30 minutes of injection. No reports of reactions have been reported in patients receiving subsequent doses or in patients who have completed their dialysis session.
According to the FDA, health care providers should stop using peginesatide and return the product to the manufacturer.
The FDA is asking health care professionals to report any adverse reactions to the FDA’s MedWatch program online, by fax, or by regular mail:
• Complete and submit the report online at www.fda.gov/medwatch/report.htm, or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178, or
• Print and complete postage-paid, pre-addressed Form FDA 3500 available at:
www.fda.gov/MedWatch/getforms.htm2. Mail to address on the pre-addressed form.
The FDA recall notice can be read here.