FDA to Hold Hearing that Could Affect Your Anemia Treatment

On September 11th, the Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will hold a joint meeting to update information related to the risk and benefits of ESA for treatment of anemia for end stage renal disease patients (ESRD).

The outcomes from this hearing could drastically change the manor in which your physician is allowed to treat your anemia.
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This is true, Gus, and at this point it is too late to provide a public comment for the committee–the deadline was 8/27. For people with cancer, the FDA committee decided that doctors could only treat anemia with ESA drugs if the hemoglobin dropped to 10 g/dL–and then treatment would have to be stopped once it reaches 10. This is a terrible idea, and cancer doctors are already working to get this changed.

It would be an even bigger disaster for people with kidney disease, who have kidney disease ALL the time (while cancer treatment usually lasts only a few weeks).

It’s not too late to Contact Your Senators and Congressperson and tell them how vital it is that you be able to keep a hemoglobin of 11-12–and how awful it feels to be below that level. (I did!). Be sure to mention that the FDA is having a hearing on 9/11/07 called the Cardiovascular and Renal Drugs Advisory Committee (CRDAC). You can look up contact info for your representatives right here on Home Dialysis Central at: http://capwiz.com/meiresearch/dbq/officials/