A: ESAs like ARANESP are
hemoglobin increasing
medicines used to reduce the
need for blood transfusions
and treat symptoms of anemia.
The FDA issued a safety alert
regarding results of a study
which showed that
darbepoetin alfa (ARANESP)
was not only ineffective in
reducing red blood cell
transfusions or fatigue in
anemic cancer patients ... but
also resulted in higher
mortality than the placebo
group.
http://www.pbm.va.gov/vamedsafe/Safety%
20Concerns%20of%20Erythropoiesis%20S
timulating%20Agents%20(ESAs).pdf
hemoglobin increasing
medicines used to reduce the
need for blood transfusions
and treat symptoms of anemia.
The FDA issued a safety alert
regarding results of a study
which showed that
darbepoetin alfa (ARANESP)
was not only ineffective in
reducing red blood cell
transfusions or fatigue in
anemic cancer patients ... but
also resulted in higher
mortality than the placebo
group.
http://www.pbm.va.gov/vamedsafe/Safety%
20Concerns%20of%20Erythropoiesis%20S
timulating%20Agents%20(ESAs).pdf
Erythropoietin
Erythropoietin is produced in the kidneys in responses to low hemoglobin in the
blood. Erythropoiesis is the process of producing new hemoglobin that starts with the
production of erythropoietin in the blood.
Hemoglobin
Anemia is a condition in which there is a deficiency in the blood's ability to carry
oxygen. Normal hemoglobin levels in the blood improves the bloods ability to carry
oxygen to the tissues.
ESAs Hemoglobin Raising Meds
FDA notified healthcare professionals of new safety information for
erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa), Epogen
(epoetin alfa), and Procrit (epoetin alfa).
Four new studies in patients with cancer found a higher chance of serious and
life-threatening side effects or death with the use of ESAs.
These research studies were evaluating an unapproved dosing regimen, a patient
population for which ESAs are not approved, or a new unapproved ESA.
FDA believes these new concerns apply to all ESAs and is re-evaluating how to
safely use this product class.
FDA and Amgen, the manufacturer of Aranesp, Epogen and Procrit, have
changed the full prescribing information for these drugs to include a new boxed
warning, updated warnings, and a change to the dosage and administration sections
for all ESAs.
Erythropoietin is produced in the kidneys in responses to low hemoglobin in the
blood. Erythropoiesis is the process of producing new hemoglobin that starts with the
production of erythropoietin in the blood.
Hemoglobin
Anemia is a condition in which there is a deficiency in the blood's ability to carry
oxygen. Normal hemoglobin levels in the blood improves the bloods ability to carry
oxygen to the tissues.
ESAs Hemoglobin Raising Meds
FDA notified healthcare professionals of new safety information for
erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa), Epogen
(epoetin alfa), and Procrit (epoetin alfa).
Four new studies in patients with cancer found a higher chance of serious and
life-threatening side effects or death with the use of ESAs.
These research studies were evaluating an unapproved dosing regimen, a patient
population for which ESAs are not approved, or a new unapproved ESA.
FDA believes these new concerns apply to all ESAs and is re-evaluating how to
safely use this product class.
FDA and Amgen, the manufacturer of Aranesp, Epogen and Procrit, have
changed the full prescribing information for these drugs to include a new boxed
warning, updated warnings, and a change to the dosage and administration sections
for all ESAs.
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suggestions. The author(s) specifically disclaim all responsibility for any
liability, loss, or risk, personal or otherwise, which is incurred as a
consequence, directly or indirectly, of the use and application of any of
the contents of this site.
intended to provide helpful and informative material on the subjects
addressed. It is written with the understanding that the author(s) is (are)
not engaged in rendering medical, health, or any other kind of
professional service(s). The reader should consult his or her medical,
health or other competent professional before adopting any of the
suggestions. The author(s) specifically disclaim all responsibility for any
liability, loss, or risk, personal or otherwise, which is incurred as a
consequence, directly or indirectly, of the use and application of any of
the contents of this site.
