In addition, on Feb. 16, the FDA began requiring doctors to undergo special training before prescribing ESAs for cancer patients.
For people with kidney disease, the FDA says that using ESAs "can increase the risk for stroke, heart attack, heart failure, blood clots and death." The agency last year required the makers of these drugs to place a black-box warning on their labels, alerting doctors to these risks.
Winkelmayer said that not using the drugs would take treatment back to a time when dialysis patients needed many transfusions and had a poorer quality of life. "Not using these drugs is really not an option, in my opinion, but we should be smart about how we use them," he said.
Dr. Ajay K. Singh, an associate professor of medicine at Harvard Medical School and the Brigham and Women's Hospital in Boston, said that "treating anemia of kidney disease is a hot issue this year."
Another recent study showed minimal benefit but an increased risk of stroke, clotting and cancer-related deaths in diabetic patients with kidney disease who were treated with Aranesp, Singh said. "The FDA plans to convene another public advisory committee, and Medicare is looking to modify the conditions of coverage for ESAs."
"Questions are being asked again about the safety of ESAs," he said.
As for the latest findings, Singh said: "I doubt that this study will change our view of how anemia should be treated in dialysis patients, but it is one more study showing that high dosages of ESAs may be associated with risk under certain circumstances."
The U.S. Food and Drug Administration has more on ESAs.
SOURCES: Wolfgang C. Winkelmayer, M.D., Sc.D., associate professor, nephrology,
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