Amgen recalls anemia drugs Epogen, Procrit due to glass flakes



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.”