U.K. releases Eprex letter
The U.K. Medicines Control Agency posted a safety message regarding 40 cases of pure red cell aplasia (PRCA) in patients treated with Eprex epoetin, which is marketed in Europe by Johnson & Johnson (JNJ) company Janssen-Cilag to treat anemia associated with chronic renal failure, chemotherapy or orthopedic surgery. The report noted a PRCA incidence of less than 1 in 10,000 patients, and said that affected patients had worsening of anemia following months or years of therapy, were unresponsive to increasing erythropoietin (EPO) doses and had circulating EPO neutralizing antibodies.
The letter also said that PRCA patients did not respond to alternative EPOs after discontinuing Eprex and became transfusion-dependent. The statement recommended that patients who stop responding to Eprex be evaluated for typical causes of anemia including iron, folate or vitamin B12 deficiency. If PRCA is diagnosed, Eprex therapy "must be discontinued," the letter stated. JNJ could not be reached for comment. ...