USFDA is ordering manufacturers of erythropoiesis-stimulating agents (ESAs) to further restrict their use in treating patients with cancer.
In fact, before this, at 22nd of April, 2008, USFDA already notified these manufacturers to have their additional safety warnings to the labeling of ESAs.
However, Amgen (manufacturer of darbepoetin alfa) did not agree on the statesment of:
- ESAs are not intended for use on patients receiving myelosuppressive therapy when the expected outcome is cured. [means ESAs should not be used along with the chemotherapy if the chemotherapy are intended to cure the patients; ESAs should only be used if the chemotherapy is adjunct therapy].
- The clear indication of when to initiate and when to discontinue ESAs dosing.
Now, USFDA is ORDERING these manufacturers to put strong Black Box Warning on the products labeling, saying:
- The drugs are not indicated for patients undergoing chemotherapy expected to cure their cancer.
- The drugs are not suppose to be administered when hemoglobin levels are greater than or equal to 10 g/100ml.
- The usage of the drug should stop if the hemoglobin exceeds a level needed to avoid blood transfusion
However, USFDA did not order warnings against giving the drugs to any patient with advanced breast cancer or head and neck cancer, despite a recommendation by an advisory panel in March.
Well, what is ESAs by the way?
They are injectable drugs, genetically engineered forms of a protein, to boost the production of red blood cells.
In Malaysia, ESAs that are available include:
- darbepoetin alfa
- epoetin alfa (Eprex)
- epoetin beta (Recormon)
They are used for anemia in chronic kidney failure (epoietin alfa) and also cancer patients (darbepoetin alfa).
Anemia is a condition where there is a lower than normal number of red blood cells in the blood, usually measured by a decrease in the amount of hemoglobin. Hemoglobin is the oxygen-carrying part of red blood cells. It gives these blood cells their red color.
In fact, ESAs are all the while linked with INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION.
Full warnings on ESAs (for the use in cancer patients):
- 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/100 ml
- The risks of shortened survival and tumor progression have not been excluded when ESAs are dosed to target a hemoglobin of
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- To minimize these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusions
- Use only for treatment of anemia due to concomitant myelosuppressive chemotherapy
- Discontinue following the completion of a chemotherapy course
I hope MIMS Malaysia can include these warnings in their drug info. I still see the statement of"Treatment may continue for up to a mth after chemotherapy"
in the drug info for epoetin beta in their official website.
The usage of ESAs is just to bring back the hemoglobin level to normal level, to avoid blood transfusion. It DOES NOT improve the quality of life of the patient, as it does not improve the symptoms of anemia (such as fatigue, weakness).
So, when your doctor want to start you on ESA, you should discuss with your doctor about:
- Why ESA treatment is being prescribed
- What are the chances you will get red blood cell transfusions if you do not take ESA
- What are the chances you will get red blood cell transfusions even if you take ESA
- How taking Epogen may affect the success of your cancer treatment
A competent doctor should be able to effectively discuss with you about these matters.
And during the discussion, you should inform the doctor if you:
- Have heart disease
- Have high blood pressure
- Have had a seizure or stroke
- Are pregnant or planning to become pregnant (for woman only)
- Are breast-feeding or planning to breast-feed (for woman only)
Plus, you should inform the doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
In fact, before this, at 22nd of April, 2008, USFDA already notified these manufacturers to have their additional safety warnings to the labeling of ESAs.
However, Amgen (manufacturer of darbepoetin alfa) did not agree on the statesment of:
Now, USFDA is ORDERING these manufacturers to put strong Black Box Warning on the products labeling, saying:
Well, what is ESAs by the way?
They are injectable drugs, genetically engineered forms of a protein, to boost the production of red blood cells.
In Malaysia, ESAs that are available include:
Anemia is a condition where there is a lower than normal number of red blood cells in the blood, usually measured by a decrease in the amount of hemoglobin. Hemoglobin is the oxygen-carrying part of red blood cells. It gives these blood cells their red color.
In fact, ESAs are all the while linked with INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION.
Full warnings on ESAs (for the use in cancer patients):
The usage of ESAs is just to bring back the hemoglobin level to normal level, to avoid blood transfusion. It DOES NOT improve the quality of life of the patient, as it does not improve the symptoms of anemia (such as fatigue, weakness).
So, when your doctor want to start you on ESA, you should discuss with your doctor about:
And during the discussion, you should inform the doctor if you: