Omontys Recall Issued Due to Deaths, Anaphylaxis Reactions

Following reports of severe and sometimes fatal allergic reactions associated with side effects of Omontys, an anemia drug that has been used during dialysis treatment with some patients, a nationwide recall has been issued to remove the medication from the market.

The FDA announced the Omontys recall on February 23, after at least 19 patients suffered serious hypersensitivity reactions after receiving the drug through a pilot program at Fresenius dialysis centers. At least three of those cases resulted in death.

The manufacturers of the medication, Affymax and Takeda Pharmaceuticals, issued a press release indicating that they were pulling all lots of Omontys from the market and urging health care providers not to use the drug.

Allergic reactions on Omontys appear to occur within 30 minutes of the first injection, which is designed to be given once per month. According to Affymax and Takeda, the reactions occurred in about 0.2% of cases, with about a third of those being serious and sometimes including anaphylaxis that requires prompt medical intervention and hospitalization. Fatal reactions occur in about 0.02% of all cases, according to the manufacturers.

“Due to the severity of the public health risk, we want to be certain that health care providers stop using Omontys,” said Howard Sklamber, who heads the FDA’s Office of Compliance in the Center for Drug Evaluation and Research. “Americans deserve medications that are safe, effective, and of the highest quality. We’re investigating the products and facilities associated with this recall and will provide updates as we learn more.”

Omontys (peginesatide) was approved less than a year ago by the FDA for the treatment of anemia in dialysis patients. Since then, Fresenius has been running an Omontys pilot program at a number of its dialysis centers. An estimated 25,000 patients have been treated with the drug.

The recall affects all lots of Omontys and healthcare providers have been alerted not to give the drug to new patients. Omontys was distributed in 10 mg Multi-dose vials with an NDC number of 64764-610-10 with lot numbers of C18685, C18881, and C19258. It was also distributed in 20 mg Multi-dose vials with an NDC number of 64764-620-20 with lot numbers of C18686 and C18696. It was distributed nationwide and in Puerto Rico and Guam.

Customers with questions and who need to return the drug to the manufacturers for a refund can call 1-855-466-6689.

The recall comes as Fresenius faces other problems over drugs used at its facilities. In early 2012, Fresenius issued a NaturaLyte and GranuFlo recall after the dialysis drugs were linked to an increased risk of heart attack and death. A number of Fresenius dialysis lawsuits have been filed in courts nationwide, and the company is accused of having hidden the problem from other dialysis centers that purchased its products. Fresenius is the largest dialysis center franchise and provider of dialysis drugs in the country.