FDA takes new look at anemia treatments

On January 8, 2010, in Minerals, by Andrea

I can’t tell you how many RNYers suffer from anemia.  It’s one of the potential side effects given the bypass of the duodenum and the lack of Intrinsic Factor from the stomach that limits the absorption of B12 that is needed for proper iron absorption.  Vicious cycle it is.  Given this, many of us get transfusions and take massive iron doses to help combat the anemia that we suffer from, which makes this a bit more alarming to me.

From Medscape:

U.S. FDA to Take New Look at Anemia Drugs

By Lisa Richwine

WASHINGTON (Reuters) Jan 07 – U.S. regulators plan to ask outside experts to re-evaluate the use of Amgen Inc and Johnson & Johnson anemia drugs when given to patients with chronic kidney disease.

Food and Drug Administration officials, in an article published in the New England Journal of Medicine on Wednesday, said the agency “anticipates convening a public advisory committee meeting in 2010 to reevaluate erythropoiesis-stimulating agents (ESAs) in people with chronic kidney disease.

ESAs include Amgen’s Aranesp and Epogen and J&J’s Procrit.

The drugs came under scrutiny after studies showed high doses could lead to cardiovascular complications or death. Strong warnings were added in recent years and sales slumped, but the medicines remain widely used for patients with kidney disease and cancer.

FDA spokeswoman Karen Riley said an “important question” for the advisory panel would be what level of hemoglobin doctors should try to achieve with the drugs.

The FDA officials, in the journal article, said “optimal hemoglobin targets have never been established” for patients with chronic kidney disease.

“Beyond lowering hemoglobin targets and reducing doses of ESAs, it is also possible that more frequent hemoglobin monitoring” and other dosing changes might “improve outcomes” for patients, the FDA officials said.

They said clinical trials had raised “major concerns regarding the use of ESAs to increase hemoglobin concentrations” in chronic kidney disease patients above levels needed to avert blood transfusions.

But the studies “do not rule out the possibility, however, that modest increases in the hemoglobin level could be beneficial,” they added.

Amgen spokeswoman Emma Hurley said the FDA article “highlights areas of incomplete understanding regarding appropriate use” of ESAs in chronic kidney disease.

The advisory panel meeting will “provide an opportunity to discuss the latest evidence on the benefits and risks” of the medicines, she said.

Centocor Ortho Biotech, the J&J unit that sells Procrit, said in a statement the company “will continue to work with the FDA to ensure that Procrit prescribing information accurately reflects the known benefits and risks of the product, and will continue to communicate this information in a timely fashion.”

New Engl J Med, online January 6, 2010.