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Last Updated September 27, 2007

EPOGEN INJURIES & WARNINGS

EPOGEN INJURIES

Research has shown that Epogen and other ESAs may cause an increased risk for heart attacks, heart failure, strokes, blood clots, accelerated tumor growth, and death.

Recently completed studies show that when ESAs were given at higher than recommended doses to patients with chronic kidney failure, there was an increased risk of death, blood clots, strokes, heart attacks, and heart failure. In other studies, patients with head, neck, or breast cancer who received these higher doses experienced more rapid tumor growth and increased chance of death.

Although the product label specifies dosing recommendations, it has been common practice to prescribe the drugs at higher doses for certain populations. The drug company has allegedly encouraged physicians to prescribe these higher doses.

When ESAs were given at recommended doses to cancer patients who were not receiving chemotherapy, studies showed an increased risk of death and no fewer blood transfusions. Patients undergoing orthopedic surgery who received the recommended doses showed an increased risk of blood clots following the surgery.

Our firm represents people across the country who have been seriously injured by Epogen and other ESAs. Contact us for a free case review by one of our experienced pharmaceutical attorneys.

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FDA WARNINGS

Pursuant to FDA mandates, a black box warning has been added to the labeling of all ESAs, including Epogen. The warning advises physicians to closely monitor hemoglobin levels and to carefully consider the life-threatening risks of ESAs. The boxed warning reads as follows:

WARNINGS: ERYTHROPOIESIS-STIMULATING AGENTS

Use the lowest dose of EPOGEN® that will gradually increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusion (see DOSAGE AND ADMINISTRATION.)

EPOGEN® and other erythropoiesis-stimulating agents (ESAs) increased the risk for death and for serious cardiovascular events when administered to target a hemoglobin of greater than 12 g/dL (see WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events.)

Cancer Patients: Use of ESAs
  • shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a hemoglobin of greater than 12 g/dL;

  • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a hemoglobin of greater than 12 g/dL;

  • increased the risk of death when administered to target a hemoglobin of 12 g/dL in patients with active malignant disease receiving neither chemotherapy nor radiation therapy. ESAs are not indicated for this population.

    • (See WARNINGS: Increased Mortality and/or Tumor Progression)

Patients receiving ESAs pre-operatively for reduction of allogeneic red blood cell transfusions: A higher incidence of deep venous thrombosis was documented in patients receiving EPOGEN® who were not receiving prophylactic anticoagulation. Antithrombotic prophylaxis should be strongly considered when EPOGEN® is used to reduce allogeneic red blood cell transfusions (see WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events).

A black box warning is the strongest warning required by the FDA. It is used when research shows a significant risk of serious or life-threatening adverse effects. In addition to the boxed warning, the warnings in other sections have been updated and changes were made to the dosing instructions for all ESAs. The black box warning was ordered by the FDA in March of 2007, after several studies reported an increased risk of death in patients using ESAs. A Public Health Advisory was also issued in March to warn consumers.

The FDA had previously issued a Public Health Advisory on November 16, 2006. The Advisory discussed the results of the CHOIR study, published that same day in the New England Journal of Medicine. The CHOIR study showed that using Procrit to raise hemoglobin levels above the recommended dose increased the risk of death, heart attack, heart failure, and stroke.

The Public Health Advisory advised physicians to carefully monitor blood hemoglobin levels and told patients to contact their doctor if they experienced a worsening of shortness of breath, pain or swelling in the legs or increases in blood pressure. The FDA did not recommend any changes to the ESA labels at that time.

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RECENT STUDIES

November 2006: "CHOIR Study" results published. Evaluated the use of Procrit in anemic patients with chronic kidney disease who were not on dialysis. Found that patients whose hemoglobin levels were raised higher than the recommended level (to 13.5 g/dL), experienced more death and life-threatening heart attacks, heart failure, and strokes than those whose hemoglobin levels were kept below the recommended level (at 11.3 g/dL).

December 2006: A Danish study being conducted on patients with head and neck cancer was stopped because the cancer seemed to recur more in patients taking Aranesp.

January 2007: Amgen announced that in one of its clinical trials, patients getting Aranesp were more likely to die than those getting a placebo. Their subjects were anemic cancer patients not on chemotherapy.

February 2007:
FDA notified that a Canadian clinical trial with lung cancer patients was stopped because those taking Eprex were dying sooner. Eprex is the ESA sold by Johnson & Johnson outside the U.S.

FDA notified that a study evaluating a new ESA, not yet approved, was stopped because of safety concerns described as a "numerical imbalance in the number of deaths".

FDA notified of preliminary results from study with patients undergoing surgery. Those who used Procrit were more than twice as likely to suffer blood clots (deep vein thrombosis).

For more information, see the FDA Information for Healthcare Professionals.

FDA Summary of Study Results:

Since ESAs work the same way, the results of the recent studies are applicable to all ESAs regardless of which specific drug was being studied. Following is an excerpt from the FDA Public Health Advisory summarizing the study results:

Patients with chronic kidney failure had an increased number of deaths and of non-fatal heart attacks, strokes, heart failure, and blood clots when ESAs were adjusted to maintain higher red blood cell levels (hemoglobin more than 12 g/dL).

Patients with head and neck cancer receiving radiation therapy had faster tumor growth when ESAs were adjusted to maintain hemoglobin levels higher than 12 g/dL.

Patients with cancer not receiving chemotherapy died sooner and had no fewer blood transfusions when ESAs were given according to the dosing recommendations for cancer patients receiving chemotherapy.

Patients scheduled for orthopedic surgery who received ESAs to reduce blood transfusions during and after surgery had more blood clots than those not given an ESA.

If you or someone you know has suffered from any of these serious side effects, please contact our offices for a free case consultation with one of our pharmaceutical attorneys.

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FDA INVESTIGATIONS

On May 10, 2007, the FDA Oncologic Drugs Advisory Committee (ODAC) met to evaluate the safety concerns associated with Epogen and the other ESAs.

The committee recommended that results of ongoing trials be submitted for FDA review as soon as data becomes available; and that additional trials be conducted to evaluate ESA safety. Further, future marketing authorization should be contingent upon additional changes in product labeling and additional trials. The committee also recommended that product labels be changed as follows:

That product labeling should specifically state that ESAs are not indicated for use in specific tumor types (breast cancer, head and neck cancer, and non small cell lung cancer) studied in trials that showed adverse safety signals. The Committee did not specify which tumor types should be added.

That product labeling should define a hemoglobin level in asymptomatic patients at which ESA should be initiated.

That the hemoglobin level at which dosing should be suspended should remain, as described in the March 2007 revised labeling, at 12 g/dL.

That product labeling should recommend discontinuation of ESAs following the completion of a chemotherapy regimen and re-evaluation of the degree of anemia with subsequent chemotherapy regimen(s).

On June 26, 2007, the Director of the FDA Office of New Drugs Center for Drug Evaluation & Research appeared before a U.S. House sub-committee to provide information about the serious risks associated with ESA use. For more information, see Dr. John Jenkins' statement.

The FDA is currently working with the drug companies to address ODAC's recommendations. The Cardio Renal Drugs Advisory Committee was to meet in the summer of 2007 to discuss safety issues in kidney patients.

Meanwhile, the FDA's position is that ESAs are safe and effective when used according to the recently revised product labeling, at the recommended dose and for the approved indications.

Nonetheless, reports of injuries and deaths associated with ESAs continue to surface. If you or someone you know has suffered serious side effects from Epogen, Aranesp, or Procrit, contact our firm for a free case review by one of our experienced pharmaceutical attorneys.

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