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Jan B. Wade · #1 (**permalink**) 03-10-2007, 07:29 AM

Analysis: New warnings on anemia drugs

WASHINGTON, March 9 (UPI) -- The Food and Drug Administration issued new warnings for anemia drugs Friday, acting on evidence that they can worsen tumors and increase the risk of death in some patients.

FDA officials said Aranesp, Procrit, and Epogen would now carry "black-box" warnings cautioning of a risk of dangerous blood clots and early death if used too aggressively in some patients.

The agency is also telling scientists to consider ending clinical trials involving the drugs.

The drugs are in a class of drugs called erythropoiesis-stimulating agents (ESAs) used to stimulate red blood cell counts. The drugs are widely used in patients undergoing cancer treatment and those with renal failure.

The drugs are approved to prevent blood transfusions in kidney failure and cancer patients. But official suggested that doctors have increasingly used ESAs to up red blood cells higher than the level needed to avoid transfusion in an effort to prevent fatigue in patients...

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jimclh · #2 (**permalink**) 03-10-2007, 11:34 PM

These drugs can still be used safely and effectively. If one follows the thousands of cases where Procrit, Epogen and Aranesp have been used on Jehovah's Witnesses, you will find that there have been hardly any problems or side effects. The drug is designed to get the patient out of the "danger area" and not to bring the patient back to a normal Hg of 13 or 14. As usual there is an extreme reaction to a report of the misuse of this drug.
At a time when blood screening is a problem (just look at all the FDA recalls and fines given to the Red Cross) and there is an ongoing blood shortage, it seems to be a overreaction to a correctable problem.

Jan B. Wade · #3 (**permalink**) 03-11-2007, 07:33 AM

Recombinant EPO has enjoyed tremendous on-label and off-label use. The effectiveness of the drug cannot be disputed, however it is only one of many "tools" in the blood management arsenal. If medical science has uncovered a downside to high doses these will be included in the risk vs. benefit discussion as doctors decide when and how to use this tool. Possible risks do not preclude using any technique or drug. Aspirin has risks and benefits as does cell salvage yet both also offer real advantages when used properly.

Recombinant EPO has proven to be a real boon for patients. I predict its effective use will continue.

Quote:

Originally Posted by jimclh

These drugs can still be used safely and effectively. If one follows the thousands of cases where Procrit, Epogen and Aranesp have been used on Jehovah's Witnesses, you will find that there have been hardly any problems or side effects. The drug is designed to get the patient out of the "danger area" and not to bring the patient back to a normal Hg of 13 or 14. As usual there is an extreme reaction to a report of the misuse of this drug.
At a time when blood screening is a problem (just look at all the FDA recalls and fines given to the Red Cross) and there is an ongoing blood shortage, it seems to be a overreaction to a correctable problem.

markeldredge · #4 (**permalink**) 03-12-2007, 09:23 AM

This morning, I have received copies of the FDA News on ESAs from the Pharmeacy Director, the Blood Bank Director, and the daily newsletters. Clearly people are concerned after the announcement on national news from the FDA that there are dangers associated with off-label usage of ESAs. Sadly, while blood conservation programs are big users or these products, it is often physicians not associated with such programs that are using the medications inappropriately, causing DUE's and investigations that validate the FDA's concerns. Perhaps this warning will get everyone on the same page and promote a better understanding of how these products can be used safely and cost-effectively.