Erythropoietins (Epo agents) widely sold and prescribed as anemia-fighting drugs that can help cancer patients avoid blood transfusions may worsen the health of some cancer patients and even hasten death.

FDA announced that Amgen Inc. and Johnson & Johnson (J&J) would add strong new “black box” warnings to their anemia drugs Procrit, Epogen, and Aranesp after several recent studies showed a higher risk of death and life-threatening side effects in some patients.

F.D.A. is re-evaluating the validity of claims in the labels and in advertisements that the drugs can raise energy levels or otherwise improve a patient’s quality of life.patients.

According to F.D.A. officials the manufacturers had never demonstrated that use of Epo actually improved energy levels or quality of life for patients undergoing chemotherapy. Rather, the drugs, which were originally for use by patients on dialysis, were approved only to reduce the need for blood transfusions.

The American Society of Clinical Oncology sent a note to its members on March 8 saying that it had learned that Medicare was cutting off reimbursement of Epo for that use, effective immediately.

FDA notified healthcare professionals in February of the results from a large clinical trial evaluating use of an erythropoiesis-stimulating agent (ESA) to treat anemia in cancer patients not receiving chemotherapy. In this study, patients received either Aranesp, an ESA, according to the approved dosing regimen, or received placebo (dummy treatment). Patients treated with Aranesp had a higher death rate and no reduction in the need for transfusions compared to those treated with placebo. The findings in the Aranesp study may apply to other brands of Epo. Additionally, the findings show that treating anemic cancer patients not currently on chemotherapy with an Epo agent may offer no benefit and may cause serious harm.

The scope od the problem was reported in the New York Times March 9 F.D.A. Warning Is Issued On Anemia Drugs’ Overuse, By ANDREW POLLACK, March 10, 2007).

Coverage continues in The Cancer Letter, an independent weekly run by Kirsten Boyd Goldberg and Paul Goldberg and from Patrica Bowling at Legalview. Bowling writes: “Studies have indicated that when doctors use the drugs to ‘cure’ the anemia that frequently is seen in cancer and kidney-failure patients, many of these patients suffer from complications and die sooner.”

F.D.A. officials say that the manufacturers had never demonstrated that use of Epo actually improved energy levels or quality of life for patients undergoing chemotherapy. Rather, the drugs were approved only to reduce the need for blood transfusions.

Studies have shown that when erythropoietins are prescribed at high levels, tumors grow faster in those who are undergoing radiation treatment for throat cancer. Women who had metastatic breast cancer and were undergoing chemotherapy in conjunction with erythropoietin use died more quickly.

So far, four recent studies in patients with cancer found a higher chance of serious and life-threatening side effects 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. 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 to include the new black box warning, updated warnings, and a change to the dosage and administration sections for all ESAs.

FDA notified healthcare professionals in February of the results from a large clinical trial evaluating use of an erythropoiesis-stimulating agent (ESA) to treat anemia in cancer patients not receiving chemotherapy. In this study, patients received either Aranesp, an ESA, according to the approved dosing regimen or placebo. Patients treated with Aranesp had a higher death rate and no reduction in the need for transfusions compared to those treated with placebo. The findings in the Aranesp study may apply to other brands of Epo. Additionally, the findings show that treating anemic cancer patients not currently on chemotherapy with an ESA may offer no benefit and may cause serious harm.

Some doctors are believed to be using erythropoietins at doses higher than those approved by the FDA; doctors are permitted to do this. Karen Weiss, a physician and an FDA official, said that many feel that “more is better.”

The Times reported that Dr. George Rodgers, a hematologist at the University of Utah, said that ”the consensus of most people is that the drugs do improve the patients’ quality of life,” and that this was generally seen when hemoglobin levels were raised to 11 to 12. ”Right now I don’t know if physicians are going to drastically change their behavior based on this data,” he said.

Dr. Rodgers, who has consulted for Amgen, is chairman of a committee that develops anemia treatment guidelines for the National Comprehensive Cancer Network, an organization of major cancer centers.

Patients may not get to see or handle the packaging materials and inserts which will now carry these printed warnings in circumstances where the product is shipped direct from pharmacy to clinic or doctor’s office and injected into the patient or, if prescribed for home use and self-injection, if the pharmacist removes the original package inserts.

Links out
FDA alert:
Erythropoiesis Stimulating Agents:
Aranesp (darbepoetin alfa), Epogen (epoetin alfa), Procrit (epoetin alfa)

Popular Anemia Drugs Have Increased Risk Of Death, Blood Clots, Strokes, And Heart Attacks, Especially In Context Of Off-label Prescribing And Use March 9, 2007. Druginjurywatch.com

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