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FDA Advisers Back Anemia Drugs for Kidney Patients
Date:10/19/2010

ents.

"The label should be adjusted, but I just don't think we have enough information to recommend a fixed dose," Dr. Judith Hochman, head of cardiology at NYU School of Medicine, told the AP.

The study published last spring, a meta-analysis of 27 trials that included more than 10,000 people who were given the erythropoiesis-stimulating agents (ESAs), found that those who took the drugs to achieve the highest blood hemoglobin targets had a 51 percent increased risk for stroke and a 33 percent increased risk for thrombosis, or blockage of an artery. The study, by an international group of experts, was published online May 3 in Annals of Internal Medicine.

The increased risk for death (9 percent) and serious cardiovascular events such as heart attacks (15 percent) did not reach statistical significance, the analysis found.

The FDA has acted to control the use of ESAs in the past, and the agency has added a "black box" warning of dangers to the drugs' labeling.

Last spring's study added emphasis to such moves, Dr. Ajay K. Singh, an associate professor of medicine at Harvard Medical School and a nephrologist at Brigham and Women's Hospital in Boston, told HealthDay at the time.

"This meta-analysis shows increased risk with no benefit," Singh said. "The supposed benefit is that ESAs improve quality of life and make people feel better. This study suggests that these drugs, used at considerable cost, don't show any benefit in terms of those endpoints."

ESAs cost Medicare $2 billion a year, Singh said, making them the most expensive drugs in terms of cost that the government has paid for.

Yet ESAs do have a role in treating some people with chronic kidney disease, despite their dangers, Singh said.

New FDA rules, put into effect earlier this year, require that Amgen, the company that markets the drugs, disseminate a guide informing all patients of the drugs' risks and that doctors discuss those
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