Amgen recalls Epogen and Procrit vials

Certain lots of Epogen and Procrit (epoetin alfa) vials, indicated for the treatment of anaemia related to HIV therapy, chronic renal failure and chemotherapy are being voluntarily recalled by Amgen and Johnson & Johnson (J&J) from specialist distributors, wholesalers, pharmacies and healthcare providers as a precaution.

The decision is based on news that the vials may contain extremely thin glass flakes (lamellae) resulting from the interaction of the formulation with glass vials over the shelf life of the product.

Although Amgen said the flakes were barely visible in most cases, and that they have fielded no complaints or reports of adverse events that could be directly tied to them, they advised patients experiencing problems to contact their doctor.

Evaluations conducted by the company indicate that 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.

According to a report on Bloomberg Businessweek on September 24, Epogen is Amgen's fourth-best-selling product, with $2.57bn in sales last year, while Procrit brought in $2.25bn for J&J, which licenses the drug from Amgen.