ARTICLE | Clinical News

Eprex erythropoeitin alfa regulatory update

December 10, 2001 8:00 AM UTC

The U.K. Medicines Control Agency posted a safety message regarding 40 cases of pure red cell aplasia (PRCA) in patients treated with Eprex, which is marketed in Europe by JNJ company Janssen-Cilag to treat anemia associated with chronic renal failure, chemotherapy or orthopedic surgery. The report noted a PRCA incidence of <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. All patients that developed PRCA were chronic renal failure patients, according to JNJ. 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, the letter recommended discontinuing Eprex therapy. JNJ said no causative factor has been identified for PRCA, and the company is investigating all possible causes. ...