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Drugs & Devices > Erythropoiesis-Stimulating Agents (ESAs)

Aranesp / Epogen / Procrit  -  Erythropoiesis-Stimulating Agents (ESAs)

Aranesp, Epogen and Procrit were approved to treat anemia in patients with chronic kidney failure and in patients with cancer whose anemia is caused by chemotherapy. Epogen and Procrit are approved for patients scheduled for major surgery to reduce potential blood transfusions and for the treatment of anemia due to zidovudine therapy in HIV patients. ESAs are not approved to treat the symptoms of anemia – including fatigue – in cancer patients, surgical patients, or those with HIV. 


Early Death & FDA Warning

The Food and Drug Administration issued warning about Erythropoiesis-Stimulating Agents (ESAs) – (Aranesp / Epogen / Procrit) the red blood cell stimulating drugs because of increasing concerns that the medications cause early death in some patients.

The group called for new warnings on erythropoietin stimulating drugs used to boost red blood cells in patients with cancer and other diseases.

The move comes only weeks after the agency issued "black box" warnings alerting the public that the drugs may speed tumor growth and promote cardiovascular problems.

The drugs were approved because of their ability to cut the need for blood transfusions in cancer patients who have anemia as a consequence of chemotherapy.  But medical clinics have seen an explosion in ESA use that government officials and cancer experts say has gone beyond the state of scientific knowledge.  In addition, the FDA believes there should be a reconsideration of the risk to benefit ratio of (ESA) in cancer patients.

Side Effects

In March 2007 the FDA placed "black box" warnings on Epogen, ProCrit and Aranesp - the three ESA drugs available in the United States. The alerts urged physicians to limit ESA dosing because of data showing the drug can:

  • speed cancer progression,
  • promote heart problems
  • cause early death in cancer patients
  • blood clots leading to heart attacks,
  • strokes.

At the same time, evidence from at least two recent studies, one in breast cancer and another in head and neck cancer, showed the drugs may promote;

  • tumors
  • and cause early death

Overdosing

Most evidence suggests that increased dangers stem not from recommended ESA use, but instead from overdosing and over-prescribing to a largely unstudied swath of patients. As many as 450,000 American patients are currently taking ESA drugs, which can cost $1,000 per treatment.

Many doctors prescribe the drugs to improve quality-of-life by treating fatigue often resulting from anemia. But FDA scientists said Thursday that no scientific studies have shown the drugs improve cancer patients' quality of life.

History

Epogen was first approved in 1993 as a way to cut the need for blood transfusion, which at the time was a major risk factor for infection including HIV. Because that risk has dropped substantially over the last 15 years, FDA officials suggested part of ESAs' original benefit may no longer apply.

Meanwhile, officials and experts blamed aggressive industry marketing for promoting ESAs as a way to boost energy, a claim not approved by the FDA.

Television and print advertisements widely distributed by Johnson & Johnson, which makes ProCrit, urged patients to seek out the drug as a way to improve vigor.

Panel chair Maha Hussein said the drugs should not be taken off the market. But she also suggested company promotion urged physicians to give higher-than-recommended doses in the hope that boosting red blood cell counts translated to more comfort for patients.

"We started out with a huge problem, which is the ad campaign problem," said Hussein, a professor of medicine at the University of Michigan.

Doctors can prescribe drugs for any reason. But regulations forbid companies from promoting unapproved indications.  Richard Pazdur, head of the FDA office in charge of cancer drugs, said agency officials were holding internal discussion about why promotional campaigns were left unchecked.  "There's a lot of concern that these are being promoted with quality of life claims that are not in the label," Pazdur said. He added that FDA officials with jurisdiction over drug advertising "need to give the American public a clear understanding as to why these ads were allowed to continue."

Experts Thursday urged the agency to further restrict use of the drugs in cancer patients, though they did not give much guidance on what those restrictions should be. The panel said the agency should consider discouraging ESA use in patients with several forms of cancer, though they did not explicitly say which forms.

They also urged that doctors be warned to discontinue using the drugs once chemotherapy is stopped.

Aranesp / Epogen / Procrit - Erythropoiesis-Stimulating Agents (ESAs)
The U.S. Food and Drug Administration (FDA) today issued a public health advisory outlining new safety information, including revised product labeling about erythropoiesis-stimulating agents (ESAs), widely-used drugs for the treatment of anemia. The drugs affected by the safety update are darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). (ESAs are genetically engineered forms of the naturally occurring human protein, erythropoietin. Natural erythropoietin is made by the kidney and increases the number of red blood cells). Read More

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