FDA issues warning on three anemia drugs

[okarol]

FDA issues warning on three anemia drugs
By Gardiner Harris
New York Times / June 25, 2011

WASHINGTON — Federal drug regulators said yesterday that three drugs that had been widely used to treat anemia in kidney and cancer patients were so dangerous to the heart that doctors should consider avoiding the medicines altogether in some patients and using less of them in others.

The Food and Drug Administration concluded that there were no risk-free doses of Epogen, Aranesp, and Procrit and that doctors should use the medicines only in patients suffering from severe anemia. Doctors have used the medicines in the past to make patients feel better and as a way to increase chemotherapy doses in cancer patients.

But there is growing evidence that the drugs may have cost many patients their lives by causing strokes and other heart problems, as well as speeding the growth of cancer tumors.

“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.’’

The medicines have cost the federal government more than $60 billion since they were introduced in 1989, and for years they were the biggest single drug expense in the federal Medicare program. The medicines have been big money makers for oncologists — who earn a mark-up for many of the medicines they prescribe — as well as dialysis providers.

But as Congress debates ways of saving money in the Medicare program, some critics have pointed to these medicines — known collectively as erythropoietin-stimulating agents — as examples of how poorly the federal government controls expenses in the program.

http://www.boston.com/business/healthcare/articles/2011/06/25/fda_warns_on_use_of_three_anemia_drugs/

[greg10]

Thanks for posting. 

The new recommendation (6/24/2011) from the FDA is basically changing the previously targeted range of 10 to 12 to "reduce or interrupt dose of ESA if hemoglobin level approaches or exceeds 11 g/dL":

Until now, product labels for ESAs have recommended dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 grams/deciliter (g/dL) in patients with CKD. The modified package insert removes this previous concept of a “target hemoglobin range.”

As a result, the package insert for ESA products now recommends that:

Physicians and their patients with chronic kidney disease should weigh the possible benefits of using ESAs to decrease the need for red blood cell transfusions against the increased risks for serious adverse cardiovascular events. For each patient, individualize dosing and use the lowest dose of ESA sufficient to reduce the need for transfusion.

For patients with the anemia of chronic kidney disease NOT on dialysis

• Consider starting ESA treatment only when the hemoglobin level is less than 10 g/dL and when certain other considerations apply
• If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of ESA.

For patients with the anemia of chronic kidney disease on dialysis

• Initiate ESA treatment when the hemoglobin level is less than 10 g/dL.
• If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of ESA.

Initiate means to give a first dose of ESA. This advice does not define how far below 10 g/dL is appropriate for an individual to initiate. This advice also does not recommend that the goal is to achieve a hemoglobin of 10 g/dL or a hemoglobin above 10 g/dL. Individualize dosing for each patient.

The modified recommendations for dosing ESAs in patients with CKD are based on data from clinical trials including TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy), which showed that using ESAs to target a hemoglobin level of greater than 11 g/dL increased the risk of serious adverse cardiovascular events, such as heart attack and stroke, and provided no additional benefit to patients.

[Jie]

Is it not too late to short sell Amgen stock?

[boswife]

so what do you suppose will convince our docs?  Take them this to read? And how safe is it to give it a go without it..  I've been fussing about him taking it as it is and now this 

[Cordelia]

I'm not surprised to read this. I had high hemoglobin after weekly shots of aranesp so my clinic backed it off to let it drop for many weeks before starting again. They told me I was at risk of stroke/heart attack. Not a very warm fuzzy feeling to have walking around knowing that risk.