J&J Warns Against Higher Procrit Doses

Doctors should stop using the anemia drug Procrit, made by Johnson & Johnson’s Ortho Biotech Products L.P., if an oxygen-carrying agent in a patient’s blood reaches high levels, the company said in documents released on Wednesday.

In a letter sent to doctors in August, Ortho Biotech said the warning was added to the drug’s label after studies revealed major complications, including blood clots and death, when doctors used Procrit to try to boost levels of hemoglobin beyond recommended levels. Researchers thought elevating hemoglobin might boost the effectiveness of chemotherapy and radiation to fight cancer. “The new prescribing information recommends that the target hemoglobin in patients with cancer should not exceed 12 grams per deciliter in men and women,” Ortho Vice President for Clinical Affairs Marc Kamin wrote in the letter. Procrit should not be used if the level rises to 13 grams or more, he added. The FDA posted the letter on its Web site on Wednesday. Procrit is used to treat anemia, mostly in cancer patients undergoing chemotherapy. Anemia, a lower than normal number of red blood cells, is usually measured by a decrease in the amount of hemoglobin, a pigment in those cells that transports oxygen. Normal levels of hemoglobin are 12 to 18 grams per deciliter of blood. The prescription drug, along with Amgen Inc.’s Aranesp, is a bioengineered version of a human protein, erythropoietin, that stimulates production of red blood cells. Combined sales of the two anemia drugs amount to several billion dollars a year. “The new recommendations result from recent investigational studies, some with erythropoietin products other than Procrit, and conducted outside of the US,” the Aug. 13 letter said. The company also told doctors the recommended starting dose should be 40,000 units a week, increased to 60,000 units if a patient’s hemoglobin level does not sufficiently increase. If the patient still does not respond, “it is unlikely that they will respond to higher doses of Procrit,” Kamin wrote. Ortho Biotech spokesman Mark Wolfe stressed the studies that uncovered the safety problems were investigational and looking at unapproved uses. Procrit is still safe for its intended use to treat anemia, he added. An FDA panel of outside experts in May called for more study of risks from the anemia drugs, including faster tumor growth and more blood clots. Ortho Biotech has had other problems concerning Procrit, including a subpoena it received last month from U.S. health officials requesting documents about the sales and marketing of the drug. Earlier this year, the company also said similar documents were requested by New York state Attorney General Eliot Spitzer. Shares of J&J closed up 74 cents to $61.15 on the New York Stock Exchange.(Source: Reuters, December 2004)