FDA issues public health advisory on risks to Procrit/Epogen & Aranesp
FDA Public Health Advisory
Epoetin alfa (marketed as Procrit,
Epogen)
Darbepoetin alfa (marketed as Aranesp)
Today, The New England Journal of Medicine published the results of a
research study about Procrit, an erythropoiesis-stimulating agent (ESA) also
known as recombinant human erythropoietin.
The study found a higher
chance of the combination of death, heart attack, hospitalizations for heart
failure and stroke in patients with chronic kidney disease who are not on
dialysis and were treated with Procrit to raise their hemoglobin levels higher
than what the labeling for the product recommends.
Procrit, like the
other ESAs Epogen, and Aranesp, increases blood hemoglobin levels, the oxygen
carrying component of blood, by increasing the number of red blood cells in the
body.
These products are used to treat anemia in certain
patients.
The maximum treatment level recommended in product labeling for
all approved ESAs is to raise blood hemoglobin levels to no higher than 12 g/dL.
The results of this latest study emphasize the importance of following this
recommendation.
In light of this research study, FDA is advising the
following:
• To reduce serious complications from the use of ESAs,
healthcare professionals should be familiar with the recommendations in the
product labeling to maintain hemoglobin levels between 10 to 12 g/dL.
•
Frequent tests to monitor blood hemoglobin levels are an important component of
an ongoing ESA treatment plan. Healthcare professionals should talk with their
patients about the importance of keeping appointments for simple blood tests to
monitor hemoglobin levels.
• Patients should contact their doctor if they
feel any worsening in shortness of breath, pain or the swelling in the legs or
increases in blood pressure.
The New England Journal of Medicine
article, published on November 16, 2006, presented the results of the Correction
of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) study.
The
CHOIR study evaluated the potential benefit and harm from treatment with Procrit
in patients with chronic kidney disease who are not on dialysis.
In the
study, harm was defined as a group of effects that included death, heart attack,
hospitalizations for heart failure and stroke.
The research found that
patients in the study who were treated with Procrit to raise their blood
hemoglobin concentration to the higher 13.5 g/dL level experienced more death
and life-threatening harm than those who were treated to raise their blood
hemoglobin concentration to the lower 11.3 g/dL level.
The FDA is
working to fully evaluate the CHOIR study data and to determine if any
additional actions are necessary in order to optimize the use of
erythropoiesis-stimulating agents. FDA plans to notify healthcare providers and
patients as additional information becomes available.
The FDA urges both
healthcare providers and patients to report adverse events to MedWatch. MedWatch
reports may be made by phone: 1-800-FDA-1088; fax: 1-800-FDA-0178; or via the
Internet at http://www.fda.gov/medwatch/index.html
see also:
Healthcare Professionals
FDA Sends Procrit/Epotin & Aranesp Warning to Healthcare ProfessionalsFDA Warns healthcare professionals of risk to Procrit/Epotin & Aranesp
FDA Advisory
FDA Public Health Advisory for Procrit, Epogen, AranespFDA issues public health advisory on risks to Procrit/Epogen & Aranesp
Procrit/Aranesp/Epogen
FDA: Procrit, Aranesp & Epogen Raise Risk for Serious ComplicationsProcrit, Aranesp & Epogen and serious cardiovascular Complications
