Anemia :: US kidney doctors concerned over FDA’s health advisory on anemia drugs

In response to the FDA’s recent public health advisory citing potential dangers of overusing Erythropoiesis-Stimulating Agents (ESAs), the Renal Physicians Association (RPA) urges caution among its doctors and patients when considering any changes to anemia management regimens.

While the F.D.A.’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 (CKD) and End Stage Renal Disease (ESRD). 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.

Anemia-management drugs have been well demonstrated to improve quality of life for CKD patients, both adult and pediatric, and have been accepted for use in this population since approval of ESAs in 1989. Before the advent of ESAs, blood transfusions were the only effective treatment for boosting dangerously low blood counts.

The RPA points out that some of the FDA advisory recommendations do not apply to CKD patients. Therefore, the RPA recommends that the risk and benefits for ESA use must be considered on an individual patient basis by the patient’s kidney doctor. The clinical standard of care has been to maintain hemoglobin concentration > = 11 g/dL, and evidence-based guidelines should continue to guide therapy.

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.

Organized in 1973, the RPA is a national medical specialty association with a membership comprised of healthcare providers in the subspecialty area of internal medicine known as nephrology. RPA’s members are engaged in diverse activities including the practice of medicine, teaching, research and all are committed to improving the care of patients with renal disease and related disorders.

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