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Last Updated: Mar 29, 2009 - 5:58:43 PM |
FRIDAY March 14, 2008 (Foodconsumer.org) -- The Food and Drug Administration on March 13 released a small note on its web site to acknowledge that the manufacturers of anemia drugs Aranesp and Epogen/Procrit sent a letter to healthcare professionals on March 6 to warn them that Boxed warnings, the highest level of warning, were changed on the labels of their anemia drugs to indicate that the drugs increase mortality and or tumor progression, shortening the cancer patients' survival.
Aranesp and Epogen/Procrit, manufactured by Amgen and Ortho Biotech, are anemia drugs known as erythropoiesis-stimulating agents are more dangerous than previously thought, according to the FDA. These anemia drugs are indicated to treat cancer patients whose counts of red blood cells are reduced by chemotherapy and other treatments to a level that is so low that blood transfusion would be otherwise justified if the drugs are not used.
The updated prescribing information includes the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Doctors give the anemia drugs to patients because they believe patients would be better off taking the anemia drugs and avoiding blood transfusion.
Based on the results from eight studies, the prescribing information has been revised to indicate the fact that "ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of ≥ 12 g/dL."
In the letter to healthcare professionals, Amgen (seller of Aranesp and Epogen) and Ortho Biotech (seller of Procrit) listed the results of eight studies as follows:
1) In a study of 939 patients with advanced breast cancer who received chemotherapy, use of the anemia drugs decreased 12-month survival;
2) In a study of 344 patients with lymphoid malignancy who received chemotherapy, use of the anemia drugs decreased overall survival;
3) In a study of 733 patients with early breast cancer who received chemotherapy, Anemia drugs decreased 3-year relapse-free and overall survival;
4) In a study of 114 patients with cervical cancer who received chemotherapy, the drugs decreased 3-year progression-free and overall survival and locoreginal control;
5) In a study of 351 patients with head and neck cancer who received radiotherapy alone, the ESAs decreased 5-year locoregional progression-free survival and decreased overall survival;
6) In a study of 522 patients with head and neck cancer who received radiotherapy, the anemia drugs decreased locoregional disease control;
7) In a study of 70 patients with non-small cell lung cancer, the drugs decreased overall survival;
8) In a study of 989 patients with non-myeloid malignancy, the anemia drugs decreased overall survival.
In response to the severe adverse effects of the anemia drugs on cancer patients, a federal advisory panel voted to call on Thursday to add more restrictions on the use of these drugs by cancer patients, according to the New York Times.
The panel recommended that the drugs should not be used patients with either breast cancer or head and neck cancer because the risk is most evident for these types of cancers although the panel also recommended that the drugs should remain available for use by many other cancer patients.
Additionally, the panelists voted to recommend that the anemia drugs should not be given to cancer patients who would otherwise have a good chance of curing their cancers. FDA officials, according to the times, said that most use of the highly dangerous anemia drugs was in patients with more advanced cancers.
While the lethal adverse effects are evident, it is not as clear why doctors should treat the patients with the anemia drugs instead of blood transfusion. Officials of the anemia drug manufacturers suggested, cited by the times that taking the anemia drugs is a better option in light of the possibility of viral and bacterial contamination in blood transfusion.
A health observer affiliated with foodconsumer.org suggested that cancer patients need to do their math to figure out which is the better option for them. Blood transfusion carries some risk, but for some patients the risk may be far less than the risk of death from the anemia drugs. A more important choice a cancer patient needs to make is the treatment of cancer. According to some unsubstantiated sources, cancer patients who did not receive conventional treatments lived longer on average than those who received treatments.
© 2004-2008 by foodconsumer.org unless otherwise specified
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