FDA Receives New Data On Risks Of Anemia Drugs

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Anemia Drugs

FDA is reviewing new data from two studies that provide furtherevidence of the risks of anemia drugs known aserythropoiesis-stimulating agents, or ESAs. The studies show thatpatients with breast or advanced cervical cancers who received ESAs totreat anemia caused by chemotherapy died sooner or had more rapid tumorgrowth than similar patients who didn't receive the anemia drug.

These two studies were not among the six studies that were describedin revised labeling approved by FDA Nov. 8, 2007, which strengthenedwarnings about ESAs in cancer patients.

Taken together, all eight studies show more rapid tumor growth orshortened survival when patients with breast, non-small cell lung, headand neck, lymphoid or cervical cancers received ESAs compared topatients who did not receive this treatment. In all of these recentstudies, ESAs were administered in an attempt to achieve a hemoglobinlevel of 12 grams per deciliter (g/dL) or greater, although manypatients did not reach that level.

FDA plans to discuss this new data and revisit the risks andbenefits of using ESAs in patients with chemotherapy-induced anemia ata public advisory committee meeting in the next few months.

"This new information further underscores the safety concernsregarding the use of ESAs in patients with cancer, which FDA addressedin previous communications," said Janet Woodcock, M.D., FDA's deputycommissioner for scientific and medical programs, chief medicalofficer, and acting director of the Center for Drug Evaluation andResearch.

"FDA is reviewing these data and may take additional action. In themeantime, FDA recommends that health care providers review the risksand benefits of ESAs outlined in the product label and discuss thisinformation with their patients."

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ESAs are a bioengineered version of a natural protein made in thekidney that stimulates the bone marrow to produce more red blood cells.

Physicians determine whether a patient is anemic and decide on ESAdosing by measuring how much of the protein known as hemoglobin ispresent in a patient's red blood cells, typically expressed in gramsper deciliter.

FDA-approved uses of ESAs are for the treatment of anemia inpatients with chronic kidney failure; for cancer patients whose anemiais caused by chemotherapy; and for those infected with the humanimmunodeficiency virus (HIV) whose anemia is caused by the HIV drug AZT(zidovudine). ESAs are also approved to reduce the number oftransfusions during and after major surgery.

On Nov. 30, Amgen, manufacturer of the three ESAs -- Aranesp,Epogen, and Procrit -- provided FDA with information from the733-patient PREPARE study of women who received chemotherapy beforeundergoing surgery for breast cancer. After three years, 14 percent ofthe patients who received Aranesp to treat their anemia had died,compared to 9.8 percent who did not receive the drug. Tumor growth wasalso faster in patients receiving Aranesp.

On Dec. 4, Amgen informed FDA of the results of a study by theNational Cancer Institute's Gynecologic Oncology Group of patientsreceiving chemotherapy and radiation for advanced cervical cancer. Thepatients were administered either Procrit to maintain hemoglobin levelsabove 12 g/dL or blood transfusions as needed. After three years, 66percent of the patients who did not take Procrit were alive and free ofcancer growth compared to 58 percent who had received the drug.

FDA approved revised boxed warnings and other safety-related productlabeling changes for ESAs in November and March 2007. Safety concernsregarding ESAs were discussed during advisory committee meetings in2004 and 2007 and labeling was revised in 1997, 2004 and 2005 toreflect new safety information

This communication is in keeping with FDA's commitment to inform thepublic about its ongoing safety reviews. FDA is committed tostrengthening the science that supports medical product safety at everystage of the product life cycle from pre-market testing and developmentthrough post-market surveillance and risk management.

Amgen is based in Thousand Oaks, Calif. Procrit is marketed anddistributed by Ortho Biotech LP of Bridgewater, N.J, a subsidiary ofJohnson & Johnson.

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