FDA warns of risk of anemia drugs

Share this article:

Medications given to treat anemia in kidney and cancer patients greatly increase the risk of cardiovascular problems and need to be used more conservatively, the Food and Drug Administration has said.

The medicines, known as Erythropoiesis-Stimulating Agents (ESA) are approved to treat anemia resulting from Chronic Kidney Disease, chemotherapy and other conditions. But clinical trials have showed an increased risk of heart attacks, thrombosis and strokes when the drugs are given at high enough levels to get a normal blood hemoglobin level. Additionally, ESAs also do not improve quality of life, fatigue or patient well-being, the FDA stated Friday.

“Healthcare practitioners should carefully consider when to begin treatment with an ESA and actively monitor dosing in patients with chronic kidney disease, keeping in mind the increased risk for serious cardiovascular events, and should talk to their patients about these potential risks,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. “The goal is to individualize therapy and use the lowest ESA dose possible to reduce the need for red blood cell transfusions.”

In addition to the side effects, critics charge that these medicines were the single biggest drug expense in the federal Medicare program, costing the federal government more than $60 billion since they debuted in 1989, The New York Times reported. “Sixty billion dollars have gone out the window on these drugs, and what do we have to show for it?” Dennis Cotter, president of Medical Technology and Practice Patterns, a nonprofit health policy research institute in Bethesda, MD, asked rhetorically in The Times.

Share this article:

More in News

Expert says providers often wrongly threatened by PEPPER reports

Instead of fearing further scrutiny by federal authorities, providers should embrace the opportunity to get feedback in the form of PEPPER reports, legal experts said Monday at the LeadingAge annual meeting in Nashville.

Healthcare reform already driving diverse, dynamic long-term care models, LeadingAge leaders say

Healthcare reform already driving diverse, dynamic long-term care ...

One way to gauge the effects is healthcare reform is by looking at ongoing changes to the continuing care retirement community model, LeadingAge officials said Monday at the association's annual ...

Federal court: Nursing home can be sued for firing hairdresser who can ...

Is the ability to transport residents in their wheelchairs an essential function of a nursing home hairdresser? A federal appeals court says it's a valid question and is allowing a hairdresser to sue a facility that fired her.