The Food and Drug Administration released Friday reducing the dosage for anemia drugs Procrit, Epogen and Aranesp for patients with chronic kidney disease due to increased risks of stroke, blood clots and death.
“FDA is recommending new, more conservative dosing recommendations for erythropoiesis-stimulating agents [ESAs] for patients with chronic kidney disease,” Dr. Robert C. Kane, acting deputy director for safety in the division of hematology products, shared during a news conference Friday, according to HealthDay.
The anemia drugs have previously been connected to increased tumor growth in cancer patients and may cause some patients to die sooner. FDA says that cancer patients have increased risk of blood clots, heart attacks, heart failure and strokes.
Current drug labels state ESAs should be used to achieve and maintain hemoglobin levels within the range of 10 to 12 grams per deciliter of blood in patients with chronic kidney disease. The agency said these target levels will be removed.
All three drugs are made by biotech giant Amgen Inc. while Procrit is sold by Johnson & Johnson. These recommendations will be added to the warning labels and other section of the package inserts.
“The goal is to individualize therapy and use the lowest dose possible to reduce the need for red blood cell transfusions,” said
John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, according to the Associated
In the US more than 20 million people aged 20 or older have chronic kidney disease, according to the Centers for Disease Control and