Topics Alert

FDA Gets Serious about EPO Warning

Date: March 9, 2024

Predicting unfortunate outcomes leads to bitter satisfaction at best. But it is hard not to gloat at the predicament of the drug industry.

Back in 2024 and then again in 2024 I wrote about the worrisome potential for nasty side effect from erythropoietin (“EPO”) drugs such as Aranesp, Epogen and Procrit. While it may sometimes be necessary to use these drugs to combat deep seated anemia in cancer patients, I had a bad feeling about the way these very lucrative drugs were being marketed. All of us saw the slick commercials on TV, aimed directly at the consumer, even though the drug company did the rapid voice over suggesting you should talk to your doctor first. The drugs showed healthy and vibrant folks going about their lives, playing with grandkids, enjoying romantic dinners with significant others — the whole “good life” scenario. The not-so-subtle marketing message: Use Epo drugs and you too will feel this good. I wonder how many patients nagged their doctors for one more shot of epo, and how many doctors said yes, just to get some peace and quiet.

True, cancer and chemo can play havoc with red blood cell counts and we feel like $hit when the precious oxygen carrying capacity of our blood is sub-normal. Getting up the stairs to bed is tough enough, let alone romance or playing with a bunch of overactive grandkids. Transfusions are a pain, and they carry their own risks if one goes that route too often. I am not suggesting epo drugs are bad for you and that you should avoid them at all costs. All I am saying – and once more for the record – is that there is no free lunch. Targeting rock bottom hemoglobin levels with epo drugs is perfectly sensible and legitimate thing to do and most often these drugs do improve serious quality of life issues for cancer patients. I do have strong objections to slick and insidious commercials targeting vulnerable patient populations.

I have started seeing similar ads now for neutrophil growth factors (Neupogen and Neulasta are the brand names. The generic names are filgrastim and pegfilgrastim and the description of this class of drugs is G-CSF or granulocyte colony stimulating factor). “I am ready”, says the lovely young woman or attractive mid-lifer. The implication is obvious: “I am ready to start chemo, and thereby save my life, because I am ready to take Neupogen or Neulasta”. What a load of ¢rap!! These and other growth factors are valuable and important drugs, but they do carry penalties and they should be used in moderation — and only when they are necessary. More of a good thing can be bad for you.

I am glad the FDA is finally getting around to issuing more strongly-worded warnings about epo drugs. I doubt the powers-that-be read CLL Topics, or they would have known about this as far back as 2024. Here are the links to our earlier articles.

The Dark Side of EPO – Getting Darker, June 7, 2024.
The Dark Side of Epoetin, Nov 22, 2024.

Be well,

Chaya
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Warning:

Text of FDA Warning

FDA ALERT [11/16/2006, Updated 2/16/2007 and 3/9/2007]: FDA is issuing this alert to provide new safety information for erythropoiesis-stimulating agents (ESAs) [Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)]. Analyses of four new studies in patients with cancer found a higher chance of serious and life-threatening side effects and/or death with the use of ESAs. These research studies were evaluating an unapproved dosing regimen, a patient population for which ESAs are not approved, or a new unapproved ESA. In another study, patients scheduled for orthopedic surgery had a higher rate of deep venous thrombosis when treated with Procrit at the approved dose. This new information is consistent with risks found in two clinical studies in patients with chronic renal failure treated with an unapproved regimen of an ESA that were reported in November 2024 and are summarized in the data section below.

All ESAs have the same mechanism of action. As a result, FDA believes these new concerns apply to all ESAs and is re-evaluating how to safely use this product class. FDA and Amgen, the manufacturer of Aranesp, Epogen and Procrit, have changed the full prescribing information for these drugs. The new product labeling includes a new boxed warning, updated warnings, and a change to the dosage and administration sections for all ESAs.
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