In another pharmaceutical industry recall, Amgen announced lots of Procrit and Epogen (Epoetin alfa) vials are being recalled from wholesalers, distributors, health care providers and pharmacies as a preventative measure. The drugs may have glass flakes (lamellae) that can result to swelling of the veins, immune system reactions, blood clots and other problems.
The California-based company stated that the glass flakes resulted from the long-term contact between the drug and the storage vials during the shelf life of the products.
Epogen and Procrit are erythropoieses-stimulating agents or ESAs. The two are a bioengineered form of natural protein that helps stimulate and maintain the red blood cells in the body. These blockbuster drugs are used in treating chronic renal malfunction, anemia associated with HIV therapy and chemotherapy. Procrit is sold by Johnson & Johnson (J&J) from its subordinate Ortho Biotech in a licensing agreement.
So far, there have been no complaints that are directly attributed to the existence of lamellae in the drugs. Emma Hurly, Amgen spokeswoman stated that the “extremely thin glass flakes” are “barely visible” and will not likely hurt patients.
Hurley added that the expiration dates of multi-dose vials are reduced to 15 months while single dose vials are now 12 months from the original 36 months shelf life.
While Lisa Vaga, J&J spokeswoman stated, “We’re taking this broad voluntary action with patients in mind,” and “We will do everything we can to ensure that our customers and patients continue to have access to Procrit.”