US FDA issues warning on dangers of EPO drugs
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Tuesday, June 28, 2011

US FDA issues warning on dangers of EPO drugs

by Shane Stokes at 8:54 PM EST   comments
Categories: Pro Cycling, Doping
Says there’s severe risks of heart problems, strokes and tumour growth

Dismissing the notion that controlled amounts of EPO-type drugs are safe, the US Food and Drug Administration has said that there’s no risk-free amount of the substances.

Speaking on Friday, FDA officials gave warnings about Epogen, Aranesp and Procrit, saying that the anemia medications were extremely dangerous to the heart and said that doctors should consider avoiding using them with some patients, and limiting the amounts for others.

Both Epogen and Aranesp are made by Amgen, which sponsors the Tour of California.

The story was reported by the New York Times, which said that evidence was growing that the drugs had killed some patients using them due to an increase in the rate of heart problems, strokes and cancer growth.

“This is a very big deal,” said Dr. Jay Wish, a professor of medicine at Case Western Reserve University in Cleveland. “It’s going to hit the dialysis population right now in a big way.”

Dr. Daniel Coyne, who is a professor of medicine at Washington University in St. Louis, said that the announcement was very significant.

“This is a shockingly bold statement by the F.D.A., but is firmly evidence-based,” Dr. Coyne said.

When EPO was first introduced to the peloton, there was a spate of sudden deaths from heart problems. The UCI introduced a hematocrit (red blood cell) limit of 50% and this reduced the danger somewhat. However the FDA announcement suggests that using the drugs in any amount carries a high degree of risk.


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