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Bone marrow stimulating drugs are beneficial in some cancer treatment circumstances, but dangerous in others. A group of drugs, Aranesp, Epogen, and Procrit, have been a vital component of cancer chemotherapy management for many years. Clearly, this class of drugs (called erythropoiesis-stimulating agents) are a critical component of symptom management that allows cancer drugs to be given at higher, more therapeutic doses. Indeed, they have enabled oncologists to give a greater therapeutic dose of chemotherapy than was previously possible because the bone marrow cells (which produce white blood cells, red blood cells and platelets) could be wiped out without these drugs resulting in serious anemia, infections, and other side effects.
In 2007 and again in 2008, the FDA issued a “Black Box” warning on these drugs because of specific circumstances of serious adverse events identified from clinical trials. These are very potent drugs, and if not administered according to the FDA-approved labeling information, could themselves cause serious and life-threatening side effects and/or death (quotes from the FDA reports). They are the proverbial â€œtwo-edged sword that have benefit on the one hand and dangers on the other.
As new information has emerged from clinical trials, the FDA has made modifications in the indications for using the drugs and monitoring their effects. They recommend that doctors use the lowest possible dose to slowly raise the hemoglobin level (as a measure of anemia) to the lowest level that would avoid the need for blood transfusions. On the other hand, they are powerful drugs themselves and recent evidence from clinical trials have shown that they can have an adverse effect in some patient settings, including an actual reductions of survival rates in certain types of cancer patients if given too long or in too high a dose. They should not be used more aggressively to raise hemoglobin levels to a normal level. Moreover, they are not beneficial for cancer patients who are not getting chemotherapy.
Readers of this blog who want more extended and specific information can go to several websites. The most recent information from the FDA was posted May, 2009 (see their website:http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109375.htm). Also, the Centocor Ortho Biotech website has a lot of educational information, in language approved by the FDA, for these three drugs at http://www.procrit.com.
There is yet another drug called Neulasta (pegfilgrastim) that is prescribed to reduce the risk of infection (initially marked by fever) in patients with some tumors receiving strong chemotherapy that decreases the number of infection-fighting white blood cells. While it also has some potentially dangerous side effects, it does not have the “black box” warnings of the three drugs listed above. For more information, see their website at http://www.neulasta.com.
If you have questions about these drugs, be sure to ask your doctor!