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FDA APPROVES HYDROXYUREA
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FDA APPROVES IMPORTANT DRUGFOR TREATMENT OF SICKLE CELL
DISEASE
The Sickle Cell Disease Association of America, Inc. (SCDAA) is
very pleased with theannouncement by the Food and Drug
Administration of the approval of hydroxyurea (under thebrand name
Droxia) for use in treating adult patients with sickle cell
disease.
This is the first time a drug has been approved specifically for
use in this disease that affectstens of thousands of Americans and
hundreds of thousands of others throughout the world.
We would like to congratulate the investigators whose work led
to the trail of hydroxyurea insickle cell disease, the National
Heart, Lung and Blood Institute (NHLBI) of the NationalInstitutes
of Health for funding the clinical trails which demonstrated the
safety and efficacy ofhydroxyurea in sickle cell disease, the
research investigators who conducted the trails,
BristolMyers-Squibb for their continued support of these studies
and the brave patients whosecourage in participating in these
studies has made it possible for may others to be able tobenefit
from the new treatment. We hope that work on the safety of
hydroxyurea in childrenwith sickle cell disease will show soon that
they can also be treated safely with the drug.
Hydroxyurea is a well-known drug, however its use in sickle cell
disease is relatively new andmust be approached with caution.
Short-term side effects must be carefully monitored andlong-term
effects are still unknown. Recognizing that many physicians are
eager to provide thistherapy to their patients, SCDAA feels it is
important to stress that each physician treatingsickle cell
patients throughout the country must be educated about the proper
use andmonitoring of hydroxyurea therapy prior to initiating such
treatment. Through its 65 MemberOrganizations, SCDAA will be happy
to work with Bristol Myers-Squibb, NHLBI and otherhealth agencies
to ensure that physicians and patients are educated about this new
treatment.
POTENTIAL SAVINGS FROM USE OF HYDROXYUREA
Estimated total U.S. sickle cell patients 65,000 *
Percent with severe pain 3-5 times per year 5.2%
Estimated number with frequent severe pain 3,380
Assuming the average annual number of episodes 4
The total number of severe pain episodes in these patients
13,520
Assuming that 50% episodes result in hospitalization 6,760
Assuming the average days of hospitalization 5
Estimated total number of hospital days for these patients
33,800
Assuming cost per day $800
Total hospitalization costs for these patients $27,040,000
Potential savings from use of hydroxyurea in these patients in
one year $13,520,000
* Estimates of sickle cell disease patients in the U.S. is now
over 70,000.
Copyright 2005 Sickle Cell Disease Association of America,
Inc.
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Approves Hydroxyurea
http://www.sicklecelldisease.org/research/archive/hyd
12/10/2010
