FDA Panel to Discuss Anemia Drugs

Rockville, MDA Food and Drug Administration (FDA) panel will meet in March to discuss the possibility of restricting sales of drugs including Procrit, Epogen and Aranesp. The drugs are all intended to fight anemia that is caused by chemotherapy; however, their safety has been called into question by recent studies.

As a result of the studies, sales of Aranesp fell by approximately 12 percent in 2007. Earlier this year, the FDA announced that it received results from two other studies that reinforced findings that patients with cancer who receive Aranesp, Epogen or Procrit have an increase in mortality rates and shorter time for tumor progression. At that time, the FDA announced that another public advisory committee meeting would be held to discuss the risks and benefits of using anemia drugs in cancer patients.

At least one study has found that Aranesp may not even be as effective as once thought. According to FDA Director John Jenkins in a statement to the Subcommittee on Health, in February 2007, the FDA notified healthcare professionals that a study found that cancer patients who were not receiving chemotherapy and who received Aranesp had, "a higher death rate and no reduction in the need for transfusions compared to those treated with placebo."

Also in 2007, the warning label for Aranesp, Epogen and Procrit was strengthened, to show the decreased survival in increased tumor progression in patients with cancer who received any of those drugs. The increased warnings were based on trials that found an increased risk of death, strokes, heart attacks and blood clots in patients with chronic kidney failure who were given the drugs at higher than recommended levels.

All this news has left many patients confused about whether or not the use of Aranesp, Procrit or Epogen might have affected their tumor progression. After all, how do you prove that your tumor has grown faster than it would have under normal circumstances? People who have lost family members after the anemia drugs were used are now trying to determine if their loved ones would have still died if the drugs were not given.

Among the findings that the FDA has announced recently:

• Patients with chronic kidney failure had increased mortality rates and increased rates of non-fatal heart attacks, strokes, blood clots and heart failure when the anemia drugs were given at high levels;

• Patients with head and neck cancer who received radiation therapy had faster tumor growth when higher levels of anemia drugs were given;

• Patients with cancer who did not receive chemotherapy not only died sooner but required no fewer blood transfusions when given the same dose of anemia drugs that is recommended for patients who receive chemotherapy; and

• Patients who received anemia drugs prior to orthopedic surgery had more blood clots than patients not given anemia drugs.

Doctors have been advised to give the lowest dose of Aranesp, Epogen and Procrit required to avoid red blood cell transfusions. Patients are now investigating lawsuits against the makers of the three drugs, seeking reimbursement for medical expenses, lost income, loss of enjoyment of life and pain and suffering.