FDA Panel Urges Stronger Warnings for Anemia Drugs

Prescribing medications in higher doses poses dangers, research has suggested.

By Steven Reinberg
HealthDay Reporter
Thursday, May 10, 2007; 12:00 AM

Copyright © 2007 ScoutNews, LLC. All rights reserved.

THURSDAY, May 10 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel on Thursday called for new warnings and additional safety studies on anemia drugs commonly used to treat patients undergoing kidney dialysis or chemotherapy.

These medications have been the subject of controversy since some of their dangerous side effects -- including the risk of heart attacks and stroke -- came to light earlier this year. In March, the FDA issued stronger label warnings for the popular drugs.

On Thursday, the agency's advisory panel of experts voted 15-2 in favor of new prescribing restrictions and 17-0 for new clinical trials to prove the safety of Amgen's Aranesp and Johnson & Johnson's Procrit, Bloomberg reported.

"Many of us are concerned on the committee and have a lot of questions," said advisory panel chairwoman Gail Eckhardt, an oncologist at the University of Colorado in Aurora, according to Bloomberg.

Eckhardt said the questions concerned the design of trials, why regulators have limited access to results from company studies, and why the drugs have been marketed for improving quality of life if there isn't sufficient evidence for the claim.

Amgen, of Thousand Oaks, Calif., claims that 4 million patients have taken the medicines since they were introduced in 1989, and more than 9,000 people have been studied in clinical trials with cancer patients, the Bloomberg report said.

"We want to consider the totality of the evidence and consider what's best for patients," Roger Perlmutter, Amgen's head of research and development, told the panel. The anemia drugs don't shorten patients' life spans or make tumors spread more rapidly, based on the findings of 55 studies, he added.

The FDA isn't required to follow the recommendations of its advisory panels but typically does.

Recent research has shown that these erythropoiesis-stimulating agents can lead to blood clots, strokes, heart attacks and death in patients with chronic kidney failure who receive them at higher-than-recommended doses, a practice that is becoming increasingly common. Other studies have discovered that higher doses might produce more rapid tumor growth in patients with head and neck cancer.