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Volume 4 • Number 1
Contents: (Full text available in print edition.)
Off-label (unlabeled) Use of Drugs [abstract]

Off-label use of drugs is widespread and unavoidable, especially when treating the young, the pregnant, the old and those with cancer. Some of the most striking advances in dermatology have followed the off-label use of drugs. This review examines some of the issues surrounding off-label use of drugs by dermatologists, illustrates the need for such use and looks at possible changes in the regulatory system.

Delays in obtaining supplementary indications cause problems

Delay, hesitancy or indecision by regulatory bodies in granting a drug supplementary approval, after it has been peer-reviewed and proven to be clinically effective and safe, results in widespread off-label prescribing and a very frustrated profession.


Unlabelled drug use provides a realistic therapeutic option; patients demand the best and safest treatment and oftentimes there is no other treatment option available. With off-label uses, industry asks why they should be asked for more money, the regulators say that they weren't asked for an additional indication, and the Doctor is left holding the bag!
Update on Drugs
Drug Warning
Dangers of alternative medicine A New Engl J Med 1998; 339: 839–841 editorial states that there is only medicine that has been adequately tested and medicine that has not, rather than two kinds of medicine—conventional and alternative. At present, the only requirement on herbal products is that they cannot claim to prevent or treat disease.

Alternative medicine should pass the same FDA testing as conventional medicine.

Protease inhibitors during pregnancy The National Institutes of Health have temporarily suspended enrollment of pregnant women into clinical trials of protease inhibitors, citing an unexpected number of premature births; of 10 babies studied, three were premature and one died in utero.

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EDITOR: Stuart Maddin ASSOCIATE EDITOR: David I. McLean INTERNET EDITOR: Harvey Lui PRINCIPAL MEDICAL WRITER: Rodger Hall MANUSCRIPT EDITOR: Rodger Hall  EDITORIAL ADVISORY BOARD: Kenneth A. Arndt, Beth Israel Hospital & Harvard Medical School, Boston; Wilma Fowler Bergfeld, Cleveland Clinic, Cleveland; Jan D. Bos, University of Amsterdam, Amsterdam; Enno Christophers, Universitäts-Hautklinik, Kiel; Hugo Degreef, Catholic University, Leuven; Richard L. Dobson, Medical University of South Carolina, Charleston; Boni E. Elewski, Case Western Reserve University, Cleveland; Barbara A. Gilchrest, Boston University School of Medicine, Boston; W. Andrew D. Griffiths, St. Johns Institute of Dermatology, London; Vincent C.Y. Ho, University of British Columbia, Vancouver; James J. Leyden, University of Pennsylvania, Philadelphia; Howard I. Maibach, University of California Hospital, San Francisco; Larry E. Millikan, Tulane University Medical Center, Louisiana; Takeji Nishikawa, Keio University School of Medicine, Tokyo; Constantin E. Orfanos, Freie Universitäts Berlin, Universitätsklinikum Benjamin Franklin, Berlin; Stephen L. Sacks, Viridae Clinic Sciences, Vancouver; Alan R. Shalita, SUNY Health Sciences Center, Brooklyn; Stephen K. Tyring, University of Texas Medical Branch, Galveston; John Voorhees, University of Michigan, Ann Arbor; Klaus Wolff, University of Vienna, Vienna
Skin Therapy Letter®. (ISSN 1201-5989) Copyright 1998 by International Skin Therapy Newsletter Inc. All rights reserved. Reproduction in whole or in part by any process in whole or in part is strictly forbidden without prior consent of the publisher in writing.
Published six times yearly by International Skin Therapy Newsletter Inc., 835 West Tenth Avenue, Vancouver, British Columbia, Canada V5Z 4E8. Tel: (604) 874-6112. Fax: (604) 873-9919. Annual subscription: Canadian $85 individual; $155 institutional (GST included). US $60 individual; $110 institutional. Outside North America: US$80 individual; $130 institutional. Quotes on multiple subscriptions and student rates supplied upon request.
Skin Therapy Letter Editor: Dr. Stuart Maddin Vol. 4 No. 1
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