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GEN News Highlights : Sep 24, 2010

Amgen Initiates Voluntary Nationwide Recall of Certain Lots of Epogen and Procrit

Products were found to contain thin glass flakes, but their potential to impact patients is expected to be low.

Amgen has voluntarily recalled certain lots of Epogen® and Procrit® (epoetin alfa) vials from specialty distributors, wholesalers, pharmacies, and healthcare providers as a precaution. The drugs are indicated for the treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy.

The product may contain extremely thin glass flakes (lamellae), the firm says, which result from the interaction of the formulation with glass vials over the shelf life of the product. Evaluations by Amgen and Centocor Ortho Biotech Products, Procrit authorized distributor in the U.S., found a low potential to impact patients who may have received the affected product.

The potential serious adverse events resulting from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic, and other vascular events and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity. To date, there have been no complaints or adverse events reported that can be directly attributed to the presence of glass lamellae, according to the companies. 

Epogen is sanctioned for the treatment of anemia in patients with chronic renal failure on dialysis. It is meant to elevate or maintain red blood cell levels and to decrease the need for transfusions in these patients.

Procrit is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, and who are being treated with zidovudine for HIV infection. It is also indicated to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which epoetin alfa is marketed, these indications may differ.