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Senior Citizen Health & Medicine
FDA Looks at Deaths, Tumor Growth from Anemia Drugs
Used for Breast, Cervical Cancer
Anemia drugs known as erythropoiesis -stimulating
agents used to treat the anemia caused by chemotherapy
Jan. 3, 2008 Patients with breast or advanced
cervical cancers who received anemia drugs known as erythropoiesis
-stimulating agents to treat the anemia caused by chemotherapy died
sooner or had more rapid tumor growth than those who did not take the
ESAs. The Food and Drug Administration is reviewing the new data from
two studies.
These two studies were not among the six studies
that were described in revised labeling approved by FDA Nov. 8, 2007,
which strengthened warnings about ESAs in cancer patients.
Taken together, all eight studies show more rapid
tumor growth or shortened survival when patients with breast, non-small
cell lung, head and neck, lymphoid or cervical cancers received ESAs
compared to patients who did not receive this treatment.
In all of these recent studies, ESAs were
administered in an attempt to achieve a hemoglobin level of 12 grams per
deciliter (g/dL) or greater, although many patients did not reach that
level.
FDA announced plans to discuss this new data and
revisit the risks and benefits of using ESAs in patients with
chemotherapy-induced anemia at a public advisory committee meeting in
the next few months.
This new information further underscores the
safety concerns regarding the use of ESAs in patients with cancer, which
FDA addressed in previous communications, said Janet Woodcock, M.D.,
FDA's deputy commissioner for scientific and medical programs, chief
medical officer, and acting director of the Center for Drug Evaluation
and Research.
FDA is reviewing these data and may take
additional action. In the meantime, FDA recommends that health care
providers review the risks and benefits of ESAs outlined in the product
label and discuss this information with their patients.
ESAs are a bioengineered version of a natural
protein made in the kidney that stimulates the bone marrow to produce
more red blood cells.
Physicians determine whether a patient is anemic
and decide on ESA dosing by measuring how much of the protein known as
hemoglobin is present in a patient's red blood cells, typically
expressed in grams per deciliter.
FDA-approved uses of ESAs are for the treatment of
anemia in patients with chronic kidney failure; for cancer patients
whose anemia is caused by chemotherapy; and for those infected with the
human immunodeficiency virus (HIV) whose anemia is caused by the HIV
drug AZT (zidovudine). ESAs are also approved to reduce the number of
transfusions during and after major surgery.
On Nov. 30, Amgen, manufacturer of the three ESAs
-- Aranesp, Epogen, and Procrit -- provided FDA with information from
the 733-patient PREPARE study of women who received chemotherapy before
undergoing surgery for breast cancer. After three years, 14 percent of
the patients who received Aranesp to treat their anemia had died,
compared to 9.8 percent who did not receive the drug. Tumor growth was
also faster in patients receiving Aranesp.
On Dec. 4, Amgen informed FDA of the results of a
study by the National Cancer Institutes Gynecologic Oncology Group of
patients receiving chemotherapy and radiation for advanced cervical
cancer. The patients were administered either Procrit to maintain
hemoglobin levels above 12 g/dL or blood transfusions as needed. After
three years, 66 percent of the patients who did not take Procrit were
alive and free of cancer growth compared to 58 percent who had received
the drug.
FDA approved revised boxed warnings and other
safety-related product labeling changes for ESAs in November and March
2007. Safety concerns regarding ESAs were discussed during advisory
committee meetings in 2004 and 2007 and labeling was revised in 1997,
2004 and 2005 to reflect new safety information
This communication is in keeping with FDA's
commitment to inform the public about its ongoing safety reviews. FDA is
committed to strengthening the science that supports medical product
safety at every stage of the product life cycle from pre-market testing
and development through post-market surveillance and risk management.
Amgen is based in Thousand Oaks, Calif. Procrit is
marketed and distributed by Ortho Biotech LP of Bridgewater, N.J, a
subsidiary of Johnson & Johnson.
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