Amgen recalls anemia drugs Epogen, Procrit due to glass flakes

The Wall Street Journal (9/27, Gryta) reports Amgen Inc. has recalled some lots of anemia drugs Epogen [epoetin alfa] and Procrit. The drugs sold by Johnson & Johnson have been recalled due to concerns they may contain glass flakes that are very thin. Amgen said the issue came about as a result of the interaction of the medications with glass vials. To avoid the problem in the future, Amgen will limit the shelf life of the drugs to 12 months, from 36 months, for single-dose vials and 15 months for multiple-dose vials. J&J spokeswoman Lisa Vaga said the company will do “everything we can to ensure customers and patients continue to have access to” Epogen and Procrit.
According to the AP (9/24, Johnson), the “glass flakes…could cause blood clots, swelling of veins, immune system reactions and other problems.” The company said “the flakes are barely visible in most cases, and they have fielded no complaints or reports about problems that can be directly tied to them.” Amgen said “the flakes are caused by the interaction of the drug with glass vials over the product’s shelf life.”
Bloomberg News (9/27, Randall, Waters) reports, “Epogen is Amgen’s fourth-best-selling product, with $2.57 billion in sales last year.” Procrit “brought in $2.25 billion for J&J, which licenses the drug from manufacturer Amgen.” The drugs “are used to stimulate red blood cells in patients with anemia caused by HIV treatment, chronic renal failure or chemotherapy.” The “recalled lots were old and the glass flakes, known as lamellae, developed as a result of long-term interaction between glass storage vials and the drug.”
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