- The Washington Times - Friday, March 9, 2007

The Food and Drug Administration yesterday said three drugs commonly used to treat cancer patients will carry new warnings for increased health risks.

Federal health investigators found that makers of anemia drugs claim their products will improve a patient’s quality of life by giving the person more energy. But in fact, the drugs are approved only to avoid blood transfusions. The prescription drugs’ advertisements, such as one displayed on the Web site for Procrit that says the drug “helps you find the strength you need,” has led to overdosing by physicians.

Recently completed clinical trials for the drugs showed an increased risk of death, strokes and heart attacks in patients with kidney failure when the drugs were given at higher-than-recommended doses.

The anemia drugs Aranesp and Epogen, made by biotech giant Amgen, and Procrit, made by Johnson & Johnson, will get stronger warnings about health risks including death, heart trauma, blood clots and tumor growth when used above recommended doses. Anemia is common with certain forms of kidney disease, especially once a patient is on dialysis, and when cancer patients take chemotherapy.

The FDA and drug manufacturers reached an agreement on revised product labeling that includes the health warnings and new dosing instructions. The warning will advise physicians to monitor red blood cell levels and adjust the drug dosages to maintain the lowest level needed to avoid a blood transfusion.

“The agency is in the process of re-evaluating the safety of Aranesp, Epogen and Procrit on the basis of the results of recent clinical trials,” said Steven Galson, director the FDA’s Center for Drug Evaluation and Research. In the meantime, FDA is advising physicians to use the lowest dose of the drugs.

Roger Perlmutter, executive director of research and development at Amgen, said the company is informing health care professionals about the revisions and said most doctors are issuing the proper dosage levels

While about 20 million Americans have kidney disease and 20 million are at risk, the District by far has the highest rate of kidney failure in the country.

In 2005, the National Minority Health Foundation, a group researching racial and ethnic health disparities, found that the District had 1,369 cases per 100,000 population, which was 44 times the national average. Black people, who are a majority of the District’s population, are at two to four times the risk for kidney disease as whites.

More blacks than whites have diabetes or hypertension, the leading causes of kidney disease. But poorer access to health care, lack of insurance or other economic factors could contribute to the District’s high rate.

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