ADELPHI, Md. - Federal health advisers said Monday that patients with failing kidneys should continue taking a group of widely used anemia drugs, despite a recent study showing they can increase the risk of stroke.
A panel of Food and Drug Administration experts voted 15-1, with one abstention, to maintain the drugs’ approval for patients with chronic kidney disease who are not yet sick enough to receive dialysis. The FDA is not required to follow the group’s advice, though it often does.
The medicines - Procrit, Aranesp and Epogen - are multibillion-dollar sellers because of their ability to boost oxygen-carrying red blood cells, reducing the need for painful blood transfusions. But sales have fallen sharply since 2007, when the FDA added the first of several safety warnings to the drugs, based on evidence they can cause tumor growth and hasten death in cancer patients. The drugs are no longer used in patients with several types of cancers.
The FDA is reviewing the medications from biotech drugmaker Amgen Inc. after a study published last year that showed patients with kidney disease who were taking the drugs were twice as likely to experience stroke compared with those taking a dummy treatment. The goal of the study was to show that higher doses of the drug could prevent heart attack, stroke and other heart-related problems, as had been assumed for years.
Doctors adjust their patients’ drug doses to maintain healthy levels of hemoglobin, a component of blood that carries oxygen and keeps anemia patients active. Anemia causes weakness and shortness of breath and is a side effect of chemotherapy and kidney failure.
Current labeling on the drugs recommends keeping patients’ hemoglobin levels between 10 grams and 12 grams per deciliter. The FDA asked its panelists whether the recommendation should be reduced to target nine grams per deciliter. But a majority of panelists sided against that proposal in a vote of 9-5 with three abstentions.
The experts said they worried patients would suffer more incidents of anemia and require more blood transfusions if lower doses were recommended. They said doctors should manage patients based on their individual health and disease history.
Panelists said additional studies are needed to find the ideal drug dosage for kidney disease patients.
“The label should be adjusted, but I just don’t think we have enough information to recommend a fixed dose,” said Dr. Judith Hochman of the New York University School of Medicine.
Amgen, based in California, makes all three drugs. Procrit is sold by Johnson & Johnson's Centocor Ortho Biotech division, under a long-standing agreement between the companies.
Last year the drugs - known as erythropoiesis stimulating agents - had combined sales of $6.3 billion, according to health data firm IMS Health.