Whats going on with EPO&procrit I heard it was causing liver damage anyone heard of this hitting the news lately
No, there have not been any reports of EPO or Procrit causing liver damage. In people who have certain types of cancer, recent studies have found worse outcomes when hemoglobins were brought up to higher (nearer to normal) levels.
Here is the press release related to the FDA announcement:
FDA issues new warnings on anemia drugs
Federal health officials issued stern new warnings Friday for doctors to more carefully prescribe widely used anemia drugs that can increase the risk of death and other serious problems in patients with cancer and kidney disease.
At issue are drugs sold under the brand names Procrit, Epogen and Aranesp. These drugs are genetically engineered versions of a natural protein, erythropoietin, that increases the number of red blood cells.
Anemia is common with certain forms of kidney disease, especially once a patient is on dialysis, and when cancer patients take chemotherapy.
But the Food and Drug Administration pointed to recent studies that found using too much of the drugs increased the risk of death, blood clots, strokes and heart attacks in patients with chronic kidney failure. In other studies, patients with head and neck cancer had more rapid tumor growth if they used higher-than-recommended doses.
Even when the anemia drugs were used at FDA-recommended doses, giving them to cancer patients not on chemotherapy increased the risk of death, the agency warned. Moreover, some doctors have begun giving the drugs to patients following orthopedic surgery, also increasing the risk of blood clots, FDA said.
Friday, the agency added stern warnings to each of the drug’s labels urging that:
• doctors monitor patients’ levels of red blood cells and use the lowest possible dose to avoid the need for blood transfusions.
• doctors and patients carefully weigh the risks of using anemia drugs vs. the risk of a transfusion if anemia gets too bad.
Amgen Inc. and Johnson & Johnson, companies that manufacture and market the drugs, both said they would work to inform doctors about the new warnings, outlined in a so-called “black box.” The warnings are the most serious a drug label can bear.
“Amgen is committed to providing timely and appropriate communications to physicians and patients whenever we become aware of new safety information that could affect clinical practice,” said Dr. Roger Perlmutter, Amgen’ s executive vice president of research and development.
The FDA also said it would take a new look at how the drugs are marketed, including claims they can improve the quality of life of cancer patients. The Web site for Procrit, for example, says the drug “helps you find the strength you need.”
“With the new label being revised today, we will certainly evaluate any marketing claims and revise them as needed,” said Stephanie Fagan, a spokeswoman for J&J’s Ortho Biotech Products LP.
A panel of FDA advisers is scheduled to discuss the drugs at a May 10 meeting. Their recommendations could lead to further revisions of the drugs’ labels, FDA officials said.
In December, lawmakers and some experts raised concerns that Medicare’s payment system encouraged overuse of Epogen, endangering patient lives and wasting taxpayer money. FDA officials said they would forward the recent data on the class of drugs to the Centers for Medicare and Medicaid Services.
The three drugs are huge sellers, with combined 2006 U.S. sales of
$10 billion, according to IMS Health Inc.
I highlighted a couple of statements in blue, because I think they’re especially problematic. The first one refers to a research study in chronic kidney disease (CKD). The CHOIR study, published in the New England Journal of Medicine did not have significant results–and this was not reported in the abstract (the only part most people read). Plus:
• The study was under-powered to find anything significant, after 549 patients withdrew from it before it was stopped.
• Patients in the high Hgb group had a significantly higher rate of high blood pressure (p=0.03) and coronary artery bypass graft (p=0.05) before the study.
• The study did not control for GFR at the start (the range was 50 to 15)–and then claimed that patients in the high Hgb group progressed to renal failure faster than controls.
• Despite worse cardiovascular outcomes in the high hemoglobin group, there were no significant changes in blood pressure in the high vs. low hemoglobin group. This seems odd.
• This study was the only one ever done–to my knowledge–of anemia treatment in kidney disease that did not find that people had a higher quality of life with higher Hgb levels. Why not? Possibly because the researchers used 3 tools with a total of 83 items (plus sub-items) to answer, wearing people out. They also did not use valid, reliable tools standardized for CKD. One wonders why.
• Somehow, despite all this, the researchers concluded that patients with stages 3-4 CKD had a 34% higher risk of adverse outcomes if their hemoglobin levels were 13.5 g/dL.
Frankly, I’m not convinced. But even if this were true, IMHO, the only person who can decide if it might be worth it in the short run to have a higher Hgb and a higher quality of life–even if it might mean a somewhat shorter lifespan–is YOU. But policymakers are rushing to take choices away from dialyzors in the name of safety and protection.
I’m particularly alarmed by the language in this press release about weighing the risks of using anemia drugs vs. the " the risk of a transfusion if anemia gets too bad." Are they kidding??! Can you imagine what would happen to the national blood supply if 350,000 people on dialysis plus millions of people with cancer started having transfusions instead medications to treat their anemia? Too bad for trauma victims or people needing surgery. Not to mention the risk of blood-borne diseases–and it’s impossible to test for everything.
To me, what the recent studies show in CKD at least, is that we don’t yet have enough data to show what the right target should be for Hgb, but caution should be used (or an informed risk/benefit decision made by YOU) before going above 12 g/dL.
I hate to reply to myself, but thought you might want to see the AAKP’s press release on this topic. It’s posted at: http://www.aakp.org/press/press-releases/2007/FDA-Black-Box-Warning/.
The way I understand the warning, it is specifically speaking of CKD not ESRD and cancer patients not on chemotherapy.
I was talking with someone today that I consider to be an authority on the subject. He assured me that hematocrit levels of 34-36 proved to provide less health problems than 30-33 and levels of 37-39 were more desirable than 34-36.
The study that brought about the warning regarding chronic patients (not on dialysis) may have been flawed in that all patients that started in the study weren’t followed through the life of the study.
While looking into the documentation regarding the FDA “Black Box Warning” on the use of drugs to treat anemia I came across what I consider incorrect word usage. I think this sloppy use of language has added a layer of confusion to an already complex issue.
The FDA document Information for Healthcare Professionals: Erythropoiesis Stimulating Agents (ESA) seems to use the terms: Chronic Kidney/Renal Failure and Chronic Kidney/Renal Disease interchangeably. I’m pretty sure they are not the same thing.
Kidney or renal, I say kidney. Chronic Kidney Disease describes a progressive condition usually divided into five stages. Stage One - CKD1 - is mildly diminished kidney function. From there kidney function continues to diminish until Stage Five - CKD5 - also know as Chronic Kidney Failure or in Medicare-speak End Stage Renal Disease (it should be obvious why people with CKD5 are not thrilled with either the Chronic…Failure or End Stage labels, why I like CKD5). A person with CKD5 needs dialysis or a transplant to stay alive.
The FDA document includes the bold, italics font (double emphasis) headline “Studies in patients with chronic renal failure” and then discusses the CHIOR and CREATE studies which were studies of people with CKD3 & CKD4. The FDA does correctly note that these studies looked at the impact of Hemoglobins at or greater than 13.5 in people with CKD. To say that these were studies on “patients with chronic renal failure” is wrong, that would be dialysis or transplant patients these were neither.
Is the FDA using a the terms incorrectly or does Chronic Renal Failure now refer to CKD 1-4 predialyzors?
That is ANOTHER thing to worry about…as if we, as dialysis patients don’t have enough…:mad: