Bad news for top-selling anemia drug (iht.com 16.11.2006)

Anemia Drug May Harm Some Patients, FDA Says (washingtonpost.com 10.3.2007)

 

Acute and chronic elevation of erythropoietin in the brain improves exercise performance in mice without inducing erythropoiesis
FASEB J. 2012 (Published online before print June 8, 2012)
Abstract Application of recombinant human erythropoietin (rhEpo) improves exercise capacity by stimulating red blood cell production that, in turn, enhances oxygen delivery and utilization. Apart from this, when applied at high doses, rhEpo crosses the blood-brain barrier, triggering protective neuronal effects. Here we show a fundamental new role by which the presence of Epo in the brain augments exercise performance without altering red blood cell production. Two different animal models, the transgenic mouse line Tg21, which constitutively overexpresses human Epo exclusively in the brain without affecting erythropoiesis, and wild-type mice treated with a single high dose of rhEpo, demonstrate an unexpected improvement in maximal exercise performance independent of changes in total hemoglobin mass, as well as in whole blood volume and cardiovascular parameters. This novel finding builds a more complete understanding regarding the central effects of endogenously produced and exogenously applied Epo on exercise performance.—Schuler, B., Vogel, J., Grenacher, B., Jacobs, R. A., Arras, M., Gassmann, M. Acute and chronic elevation of erythropoietin in the brain improves exercise performance in mice without inducing erythropoiesis. (...)

Erythropoiesis-Stimulating Agents — Time for a Reevaluation
NEJM 2010 (January 6)
Epoetin alfa was approved in 1989 by the Food and Drug Administration (FDA) for the treatment of anemia associated with chronic kidney disease “to elevate or maintain the red blood cell level . . . and to decrease the need for transfusions.” Although epoetin alfa and darbepoetin alfa, a related erythropoiesis-stimulating agent (ESA) approved in 2001, have been widely accepted for this indication, optimal hemoglobin targets have never been established. (...)

ASH: Anemia Drugs' Mortality Risk Supported in Cancer Patients
medpagetoday.com 6.12.2008
SAN FRANCISCO, Dec. 6 -- Increased death rates among cancer patients taking erythropoiesis-stimulating agents were supported in a large meta-analysis, researchers said here.

Among nearly 14,000 patients in 53 studies, those taking the anemia drugs were 17% (95% CI 6% to 30%) more likely to die during the study, and their overall survival chances were reduced by 6% (95% CI 0% to 12%), reported Julia Bohlius, M.D., M.Sc.P.H., of the University of Bern in Switzerland.

The findings, which Dr. Bohlius disclosed during a press briefing at the American Society of Hematology meeting here, confirmed results reported earlier in individual studies. (See: Anemia Drugs Hike Risk of VTE and Death in Cancer Patients and Risks of Anemia Drugs in Chemotherapy Patients Are Bolstered)

The trials they included studied epoetin alfa (Epogen, Procrit), epoetin beta (NeoRecormon), or darbopoetin alfa (Aranesp). (...)

EMEA recommends a new warning for epoetins for their use in cancer patients
worldpharmanews.com 12.7.2008
The European Medicines Agency (EMEA) has recommended updating the product information for epoetin-containing medicines with a new warning for their use in cancer patients stating that blood transfusion should be the preferred method of correcting anaemia in patients suffering cancer. Epoetin-containing medicines are indicated in patients with chronic renal failure and for the treatment of anaemia in symptomatic patients with non-myeloid tumours receiving chemotherapy. (...)

Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)
fda.gov 12.3.2008
[Posted 03/12/2008] Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: (...)

F.D.A. Expands Warnings on Anemia Drugs
nytimes.com 7.3.2008
WASHINGTON (AP) -- Drug maker Amgen Inc. said Friday it expanded black box warnings about risks of death and tumor growth of its blockbuster anemia drugs. (...)

The changes apply to Thousand Oaks, Calif.-based Amgen's Aranesp and Epogen, as well as Johnson & Johnson's Procrit. (...)

Anemia drugs up death risk in cancer patients: study
reuters.com 26.2.2008
CHICAGO (Reuters) - Treating cancer patients with anemia drugs increases their risk of blood clots and death, U.S. researchers said on Tuesday, confirming concerns about these widely used drugs.

Researchers said the drugs, including Amgen Inc's Aranesp and Johnson & Johnson's Procrit, raised the risk of death by 10 percent in patients who took them, a finding that could not be explained by the higher blood clot risk alone. (...)

Mayo Clinic Study Links Anemia Drugs to Leukemia Risk
nytimes.com 11.12.2007
Anemia drugs from Amgen and Johnson & Johnson may raise the risk that patients with a bone marrow disease will later develop leukemia, according to an analysis of 30 years of patient records. (...)

(Anm: What is leukemia? - Danilo Allegra and Dania Puggioni (ed.ted.com).)

FDA Issues New Warning for Anemia Drugs
therapeuticsdaily.com 8.11.2007
WASHINGTON_The Food and Drug Administration called on physicians Thursday to warn cancer patients undergoing chemotherapy that certain anti-anemia drugs led to tumor growth and decreased survival in some patients.

At issue are drugs sold under the brand names Procrit, Epogen and Aranesp. These drugs are genetically engineered versions of a natural protein that increases the number of red blood cells. The drugs generated $10 billion in sales last year. (...)

FDA calls for warnings on anaemia drugs amid reports of incentives to doctors
BMJ 2007;334:1022 (19 May)
The committee of the US Food and Drug Administration (FDA) that advises on oncology drugs last week recommended new warnings on erythropoiesis stimulating drugs that are given to patients undergoing chemotherapy to counteract anaemia. Patients undergoing dialysis are also often given the drugs. (...)

The committee said that such synthetic erythropoietins (also called epoetins or "epo drugs") were associated with an increased risk of cardiovascular events and possibly of progression of cancer. It unanimously recommended new clinical trials. (...)

Doctors Reap Millions for Anemia Drugs
nytimes.com 9.5.2007
Two of the world’s largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses.

Getting Paid to Prescribe Drugs
Do you trust your doctor to prescribe the appropriate drugs for you? (...)

FDA Documents Question Safety of Anemia Medications in Advance of Meeting
kaisernetwork.org 9.5.2007
FDA on Tuesday posted documents on its Web site questioning the safety of higher doses of anemia drugs manufactured by Amgen and Johnson & Johnson that are used by chemotherapy and kidney failure patients, the Wall Street Journal reports. FDA released the documents in advance of an advisory panel meeting scheduled for Thursday that will consider whether the labels for Amgen's Aranesp and Epogen and J&J's Procrit require new warnings for cancer patients (Loftus, Wall Street Journal, 5/9). (...)

Physician Payments
The New York Times on Wednesday examined how Amgen and J&J pay "hundreds of millions of dollars to doctors every year" to treat patients with EPO drugs. Federal law prohibits pharmaceutical companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients at pharmacies, but companies can rebate part of the price to doctors who purchase treatments that are administered in their offices. Anemia drugs are injected or delivered intravenously in doctors' offices or dialysis centers. Physicians receive rebates after they buy the drugs from the companies. Rebates generally are higher for physicians who agree to use one company's EPO drugs exclusively. Doctors also receive reimbursements from Medicare or private insurance companies for the drugs, often at a markup more than the purchase price. (...)

(Anm: Autoimmune attack underlying kidney failure. Interstitial nephritis, a common cause of kidney failure, has a complex and largely unknown pathogenesis. In a new published paper in The Journal of the American Society of Nephrology, a team of researchers led from Karolinska Institutet shows how interstitial nephritis can develop from an autoimmune attack on the kidney's collecting duct. (medicalnewstoday.com 24.3.2016).)

Cancermedicin riskerar öka dödligheten
netdoktor.passagen.se 22.3.2007
Hormonpreparatet erythropoietin, epo, som stimulerar nybildningen av röda blodkroppar, används ibland för att motverka blodbrist vid cancerbehandling. Nu tror man att medicineringen istället kan öka dödligheten hos patienterna. Under april ska ett expertmöte hållas där man ska ta ställning till huruvida epo ska finnas med i tumörvården eller inte. (...)

Anemia Drug May Harm Some Patients, FDA Says
washingtonpost.com 10.3.2007
The Food and Drug Administration warned yesterday that anemia-fighting drugs called erythropoietins, which had $10 billion in U.S. sales last year, are being used so aggressively that they may be harming some patients.

Recent studies have shown that when physicians use the hormone-like drugs to "cure" the anemia commonly seen in cancer and kidney-failure patients, some patients suffer complications and die earlier.

Some physicians are apparently using erythropoietins at doses beyond what the FDA-approved instructions recommend, as they are allowed to do.

Many have felt "in the past that more is better," Karen Weiss, a physician and FDA official, said in a news conference yesterday. "I think there is considerable off-label use of this drug."

The drugs will now carry a "black-box" warning -- the strongest possible -- saying they should be used at the lowest dose necessary to avoid the need for a blood transfusion. They should not be used to fully reverse anemia. (...)

Bad news for top-selling anemia drug
iht.com 16.11.2006
NEW YORK: A new medical study suggests that high doses of a best- selling drug used to treat anemia in dialysis and cancer patients may increase the risk of heart problems and death.

Each year, almost a million people in the United States receive prescriptions for the drug, known as epoetin, or for darbepoetin, a closely related drug also used in anemia treatment.

Worldwide, sales of the two drugs - sold under the brand names Epogen, Procrit and Aranesp - exceeded $9 billion in 2005 for Amgen and Johnson & Johnson, their makers.

In the first nine months of 2006, Amgen sold $4.9 billion worth of Aranesp and Epogen, accounting for almost half of its revenue.

Johnson & Johnson, which sells epoetin under the brand names Procrit in the United States and Eprex everywhere else, reported sales of $2.4 billion in the first nine months of 2006, down slightly from 2005. (...)

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