Mayo clinic study links anemia drugs to leukemia risk.Anemia drugs from Amgen and Johnson & Johnson may raise the risk that patients with a bone marrow disease will later develop leukemia, according to an analysis of 30 years of patient records, Bloomberg News reported Dec. 11.
Mayo Clinic researchers reviewed records of 311 patients with primary myelofibrosis Myelofibrosis Definition
Myelofibrosis is a rare disease of the bone marrow in which collagen builds up fibrous scar tissue inside the marrow cavity. , a scarring of the bone marrow, from 1976 to 2006. The drugs--Aranesp and Epogen from Amgen and Procrit from Johnson & Johnson--were linked to leukemia among 27 patients who developed the disease, according to research presented at the American Society of Hematology meeting in Atlanta.
Past studies linked anemia drugs to heart attack, stroke and death when used in high doses.
The study also found a higher risk of leukemia among patients who took danazol, a modified form of testosterone. Risk was also higher for patients with a high count of immature leukemia cells and a low number of platelet cells in the blood. Patients who took other treatments, like thalidomide thalidomide (thəlĭd`əmĭd'), sleep-inducing drug found to produce skeletal defects in developing fetuses. The drug was marketed in Europe, especially in West Germany and Britain, from 1957 to 1961, and was thought to be so safe that and interferon-alpha, had no higher risk, researchers said.
Patients with primary myelofibrosis feel fatigued, and they sometimes take an anemia drug to stimulate growth of oxygen-carrying red blood cells Red blood cells
Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body.
Mentioned in: Bone Marrow Transplantation
red blood cells .
The findings needed to be confirmed in a trial to answer the question about anemia drug risk, Ayalew Tefferi, M.D., a Mayo Clinic hematologist he·ma·tol·o·gist
A physician specializing in hematology.
A medical specialist who treats diseases and disorders of the blood and blood-forming organs. and the study's lead investigator, said in a statement.
"While we cannot take these findings as an absolute, at the same time, they cannot be ignored," Tefferi said. "Treatment decisions regarding the use of anemia drugs in patients with primary myelofibrosis should carefully be evaluated."
In November, FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. strengthened the black box safety warning on the drugs to reflect concerns that they might elevate risk of death, heart attack, stroke and the progression of certain cancers.
Amgen said that preliminary follow-up results from the independent PREPARE breast cancer study showed that the group that received Aranesp with chemotherapy prior to surgery had numerically more deaths and reports of tumor growth than the control group, Reuters reported Dec. 6.
At the time, Amgen cautioned that no conclusions should be drawn from the data until the final study report is completed.
Separately, Johnson &Johnson's Ortho Biotech announced results from an updated analysis of data from a study in which a group of chemotherapy-treated patients with advanced cervical cancer Cervical Cancer Definition
Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors. used its anemia drug, Procrit, to maintain hemoglobin levels above 12 grams per deciliter deciliter /dec·i·li·ter/ (dL) (des´i-le?ter) one tenth (10minus;1) of a liter; 100 milliliters.
100 cubic centimeters (cc).
Mentioned in: Hypercholesterolemia of blood.
The data showed a statistically non-significant trend toward decreased progression-free and overall survival in the patients treated with Procrit, Ortho said.
The study, conducted by the Gynecologic Oncology Group The Gynecologic Oncology Group (GOG) is a non-profit organization funded by the National Cancer Institute with the purpose of supporting research for the prevention and treatment of all gynecologic cancers, such as ovarian cancer, cervical cancer, endometrial cancer, vulvar cancer, (GOG), was terminated in 2003 due to potential concerns about the formation of potentially life-threatening blood clots Blood Clots Definition
A blood clot is a thickened mass in the blood formed by tiny substances called platelets. Clots form to stop bleeding, such as at the site of cut. in patients receiving Procrit.
Ortho said the updated analysis provided more evidence to support recent anemia drug label changes, which warn doctors to use the lowest dose needed to avoid transfusions, while not exceeding an upper hemoglobin safety limit of 12 grams per deciliter of blood.