FDA Approves Hydroxyurea http://www.sicklecelldisease.org/research/archive/hydrox.

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FDA APPROVES HYDROXYUREA

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FDA APPROVES IMPORTANT DRUG FOR TREATMENT OF SICKLE CELL DISEASE

Member Organizations The Sickle Cell Disease Association of America, Inc. (SCDAA) is very pleased with the
Educational Opportunities announcement by the Food and Drug Administration of the approval of hydroxyurea (under the
brand name Droxia) for use in treating adult patients with sickle cell disease.
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This is the first time a drug has been approved specifically for use in this disease that affects
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tens of thousands of Americans and hundreds of thousands of others throughout the world.
MARAC
SCD in Childhood We would like to congratulate the investigators whose work led to the trail of hydroxyurea in
Outpatient Management sickle cell disease, the National Heart, Lung and Blood Institute (NHLBI) of the National
Transitioning Care Institutes of Health for funding the clinical trails which demonstrated the safety and efficacy of
hydroxyurea in sickle cell disease, the research investigators who conducted the trails, Bristol
Day Hospital
Myers-Squibb for their continued support of these studies and the brave patients whose
Health Maintenance courage in participating in these studies has made it possible for may others to be able to
Social Services benefit from the new treatment. We hope that work on the safety of hydroxyurea in children
Genetic Counseling with sickle cell disease will show soon that they can also be treated safely with the drug.
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Hydroxyurea is a well-known drug, however its use in sickle cell disease is relatively new and
Links & Resources must be approached with caution. Short-term side effects must be carefully monitored and
How You Can Help long-term effects are still unknown. Recognizing that many physicians are eager to provide this
therapy to their patients, SCDAA feels it is important to stress that each physician treating
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sickle cell patients throughout the country must be educated about the proper use and
Search monitoring of hydroxyurea therapy prior to initiating such treatment. Through its 65 Member
Organizations, SCDAA will be happy to work with Bristol Myers-Squibb, NHLBI and other
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health 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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