Thalidomide Information
FDA Announces Approval of Drug for Hansen's Disease (Leprosy) Side Effect;
Imposes Unprecedented Authority to Restrict Distribution
On July 16, 1998, FDA approved the use of thalidomide for the treatment of
the debilitating and disfiguring lesions associated with erythema nodosum leprosum (ENL),
a complication of Hansen’s Disease, commonly known as leprosy. Because of
thalidomide’s potential for causing birth defects, FDA invoked unprecedented
regulatory authority to tightly control the marketing of thalidomide in the United States.
A System for Thalidomide Education and Prescribing Safety (S.T.E.P.S) oversight program
has been initiated that includes limiting authorized prescribers and pharmacies, extensive
patient education about the risks associated with thalidomide and a 100% patient
registry. This oversight program is designed to help insure a zero tolerance policy
for thalidomide exposure during pregnancy.
Celgene Corporation of Warren, NJ, will market thalidomide as Thalomid.
The information presented on this page includes consumer and patient
information, thalidomide advisory committee and workshop transcripts, the approved
labeling text and the medical review on which the decision to approve this drug was based.
Also included are selected links to other web sites containing thalidomide information.
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Do Not Buy Thalomid
(thalidomide) Over the Internet
- You should not buy Thalomid (thalidomide) over the Internet
because you will bypass important safeguards designed to
protect your health (and the health of others).
- Thalomid has special safety restrictions on how it is
distributed to the public. Also, drugs
purchased from foreign Internet sources are not the
FDA-approved versions of the drugs, and
they are not subject to FDA-regulated manufacturing controls
or FDA inspection of manufacturing facilities.
To learn more about buying drugs safely, please see
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Frequently Asked Questions and
Answers about Thalidomide
Thalidomide:
Potential Benefits and Risk. An Open Public Scientific Workshop Sponsored by
the National Institutes of Health and the Food and Drug Administration, September 9-10,
1997, Bethesda, MD.
Executive
Summary
Sep 9, 1997 Transcript
Sep 10, 1997
Transcript
FDA's Medical Review of Thalidomide Clinical Development
The System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.)
program. Warren, NJ: Celgene Corporation, 1998. [Will be added at a later
date.]
Forty-Seventh Meeting of the Dermatologic and Opthalmic Drugs Advisory
Committee, Center for Drug Evaluation and Research; Food and Drug Administration,
September 4-5, 1997, Bethesda, MD.
Sep 4, 1997 Transcript. 271 pages. Doc. formats: RTF, PDF  .
Sep 5, 1997 Transcript. 211 pages. Doc. formats: RTF, PDF .
Supplementary Information Resources
These additional information resources available on the FDA and National
Library of Medicine web sites provide some useful background information on this topic.
Milestones
in U.S. Food and Drug Law History. FDA, 1995.
FDA Issues Approvable Letter to Celegene for Thalidomide: Talk Paper,
FDA, Sep 19, 1997.
Giving Thalidomide a Second Chance, by Herbert Burkholz. FDA Consumer,
Sep-Oct 97.
Thalidomide:
Potential Benefits and Risks. Current Bibliographies in Medicine 97-4.
Bethesda, MD: National Library of Medicine, 1997. Contains 1495 citations
to the medical literature on thalidomide from January 1963 through July 1997.
Some of these documents are in Portable Document
Format (PDF) to retain the original format. To view or print these
documents, you must use the Adobe Acrobat viewer. Acrobat is free and available directly
from Adobe's website with full installation instructions. 
01/06/06
http://www.fda.gov/cder/news/thalinfo/default.htm
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