In a decision that contradicts a recent choice by Medicare officials to continue reimbursing for the drugs at current dosage levels, the FDA is advising cutbacks on dosage for anemia drugs sold by Amgen and Johnson & Johnson. The agency says evidence is mounting that high doses of the drugs boost the risk of heart attack, stroke and other heart problems in kidney patients.
Indeed, the agency says the drugs can have such profound effects on the heart, that they should be avoided completely in some patients, the New York Times reports. Studies have been unable to identify a safe dosing level, the FDA said in a safety announcement, so doctors should use the lowest possible dose. New cautionary language will be added to the boxed warning already on the products' labels.
Doctors use this class of drugs--erythropoesis-stimulating agents, or ESAs--to treat anemia in patients with chronic kidney disease and in patients with cancer. Amgen makes and sells Aranesp and Epogen, while J&J markets the Amgen-made Procrit. The new safety announcement applies to patients with chronic kidney disease. "This is a very big deal," Dr. Jay Wish, a professor of medicine at Case Western Reserve University, told the NYT. "It's going to hit the dialysis population right now in a big way."
Safety concerns about these drugs have been growing for several years; not only have they been linked with cardiovascular troubles, but also to potential tumor growth. FDA has convened two advisory committee meetings to discuss their safety, and Medicare officials have been reviewing study data. Although sales have dropped off substantially, they're still big sellers. Epogen racked up $2.5 billion in U.S. sales last year, while Aranesp accounted for $1.1 billion.