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Special Article
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Volume 331:1348-1349 November 17, 1994 Number 20
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Drug Promotion for an Unlabeled Indication -- The Case of Topical Tretinoin
Robert S. Stern

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In 1972, topical tretinoin (Retin-A, Ortho Pharmaceutical) was approved for the treatment of acne. Today this remains the only medical indication for its use approved by the Food and Drug Administration (FDA). In 1988 a highly publicized study reported that topical tretinoin improves the appearance of "photoaged" skin1. Since then, the manufacturer of topical tretinoin has conducted an active, controversial multimedia effort to ensure that the general public and the medical profession are aware of the "unlabeled" use of tretinoin to treat benign cutaneous changes, such as wrinkles and brown spots, that may be annoying to patients because of . . . [Full Text of this Article]

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From the Department of Dermatology, Beth Israel Hospital, and Harvard Medical School, Boston.

Address reprint requests to Dr. Stern at Beth Israel Hospital, 330 Brookline Ave., Boston, MA 02215.

References


Related Letters:

Drug Promotion
Hoberman D., Puma J. L., Cohen S. N., Mossinghoff G. J., Stryer D. B., Bero L. A., Kalish R. S., Kessler D. A., Rose J. L., Temple R. J., Schapiro R., Griffin J. P., Stern R. S.
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N Engl J Med 1995; 332:1031-1033, Apr 13, 1995. Correspondence

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