J&J adds warning to Eprex labeling

The Canadian and European prescribing information for Johnson &Johnson's erythropoietin-based drug Eprex (epoetin alfa), used to treat anemia, is being revised to draw attention to cases of pure red cell aplasia, a rare and severe form of anemia estimated to affect less than 1 in 10,000 patients receiving the drug. PRCA develops when a patient's bone marrow fails to generate red blood cells and is characterized by a severe and sudden feeling of tiredness or shortness of breath. The company has sent out "Dear Doctor" letters to prescribers to inform them of the changes.

Eprex, which is also marketed under the Procrit brand name, has been on the market for the last 12 years, and was launched in Canada in 1990, It is indicated for the treatment of anemia in chronic renal failure patients and anemia caused by cancer chemotherapy, but the company notes that only patients with the former condition have been affected by PCRA. From its first launch through to September 15, 2001, 40 cases of suspected or confirmed PRCA have been linked to the drug, with seven of these reported in Canada.

J&J's share price dropped nearly 2% to $57.23 on the news, even though analysts noted that the effect has been seen with other EPO products, including Amgen's Epogen (epoetin alfa) and Roche's NeoRecormon (epoetin beta). Some viewed any negative newsflow on Eprex as potentially damaging given the threat of competition from Amgen's new product Aranesp (darbepoetin alfa; Marketletters passim).