ROCKVILLE, Md., March 12 (UPI) -- While the U.S. Food and Drug Administration last week added new warnings to anemia drugs, U.S. kidney doctors urge caution in changing patient care.
The FDA warned last week that doctors who put kidney disease/cancer patients on Amgen's Aranesp or Epogen, or Johnson & Johnson's Procrit to treat anemia, should monitor the patients' red-blood-cell counts, in light of new evidence that the so-called erythropoiesis-stimulating agents can worsen tumors or increase patients' mortality risk.
However, the Renal Physicians Association issued a statement Monday urging doctors to tread carefully when considering any changes to anemia management regimens.
"While the FDA's black box warning should certainly be closely evaluated by nephrologists, RPA is concerned that initial response to the announcement and media reports could lead to unacceptably low hemoglobin levels in patients with chronic kidney disease and end stage renal disease."
The group added, "Furthermore, RPA believes that the advisory as currently drafted may be misleading and only partly applicable to CKD and ESRD patients, and as a result, could cause 'considerable confusion' among kidney patients and the kidney community."
Because not all of the FDA's recommendations apply to CKD patients, "the risk and benefits for ESA use must be considered on an individual patient basis by the patient's kidney doctor. ... RPA encourages nephrologists to continue making treatment decisions based on clinical judgment, and patients to consult their doctors with any questions about the recent advisory."
