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TOX LESSONS LEARNED: FOUR DECADES FDA DERMATOLOGY DRUGS WITHDRAWN

Explore the history of FDA-regulated dermatologic drugs withdrawn for safety reasons in the past 40 years. Delve into the complexities, inconsistencies, and improvements in science, with a focus on cancer-related risks and regulatory judgments. Discover the impact on public health and the challenges in understanding the clinical relevance of drug assays. This informative study examines the withdrawn drugs and their associated health risks, shedding light on the evolution of dermatologic drug safety.

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TOX LESSONS LEARNED: FOUR DECADES FDA DERMATOLOGY DRUGS WITHDRAWN

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  1. TOX LESSONS LEARNED: FOUR DECADES FDA DERMATOLOGY DRUGS WITHDRAWN HOWARD I. MAIBACH, M.D. PROFESSOR DEPARTMENT OF DERMATOLOGY UNIVERSITY OF CALIFORNIA SAN FRANCISCO, CALIFORNIA 94143 – 0989

  2. BIG PICTURE • COMPLEXITY ! • INCONSISTENCY • SCIENCE IMPROVING • CANCER : - ASSAYvsDISEASE

  3. DISCLAIMER NEITHER SUPPORT NOR DENY THESE REGULATORY JUDGEMENTS

  4. THEORY • PERCIVAL POTTS & SCROTUM - SCROTUM – HIGHLY PERMEABLE • SKIN PAINTING ASSAYS – 100 YRS • HUMAN SKIN TUMORS – OBVIOUS • INTERNAL ORGANS? - BLADDER ? (DYES) - BLOOD ? (BENZENE)

  5. WITHDRAWALS 1) BITHIONOL – 1967 PHOTOACD 2) HALOGENATED SALICYLANILIDES – 1975 PHOTOACD 3) *CHLOROFORM – 1976 CANCER 1976 – NCI – ORAL HEPATIC & RENAL 4) AZARIBINE – 1976 THROMBOEMBOLISM

  6. WITHDRAWALS – con’t. 5) ZIRCONIUM – 1976 GRANULOMA *K ARSENITE 1980 CANCER J. HUTCHINSON (100 YRS.) BENOXAPROFEN 1982 RENAL & HEPATIC 8) CHLORHEXIDINE 1984 BURNS

  7. WITHDRAWALS – con’t. 9) TEMAFLOXACIN – 1992 RENAL & HEPATIC 10) ASTEMIZOLE – 1999 DRUG - DRUG INTERACTION 11) TERFENADINE – 1997 DRUG - DRUG INTERACTION 12) ETRETINATE – 2002 TERATOGENIC

  8. WITHDRAWALS – con’t. EFALIZUMAB – 2009 PML (PROGRESSIVE MULTIFOCAL LUEKOENCEPHALOPATHY)  CANCER: 2/13

  9. BLACK BOX • METHOTREXATE LYMPHOMA • TACROLIMUS LYMPHOMA • PIMECROLIMUS CLINICALRELEVANCE – SUBJUDICE

  10. “PACKAGE INSERT LABEL” PHOTOCARCINOGENICITY - RETINOIC ACID - BENZOYL PEROXIDE CLINICALRELEVANCE: SUBJUDICE

  11. DERMATOLOGIC DRUGS ORAL / PARENTERAL ~ HALF – ANIMAL ASSAY + CLINICALRELEVANCE: SUBJUDICE

  12. CONCLUSIONS SIGNIFICANT PROGRESS: - PHOTOIRRITATION - ALLERGIC CONTACT DERMATITIS - PHOTOALLERGIC CONTACT DERMATITIS - DRUG - DRUG INTERACTION - CLINICAL TRIAL DESIGN MUCH REMAIN TO BE UNDERSTOOD: - CLINICAL RELEVANCE OF CARCINOGENICITY ASSAY

  13. WEAK LINKS • PHARMACOVIGILENCE • COSMETIC VIGILENCE • CONSUMER PRODUCT VIGILENCE

  14. POWER • IARC ! • NEW COMPUTER DATA BASES • FUTURE - BRIGHT ! - SKIN – BIOMARKER

  15. REFERENCE M. MARTIN & H. MAIBACH: DERMATOLOGIC DRUGS WITHDRAWN BY THE FDA FOR SAFETY REASONS MARZULLI & MAIBACH: DERMATOTOXICOLOGY,8THED, INFORMA, 2012, p. 500-509

  16. HOWARD I. MAIBACH, MD TELEPHONE: (415) 673 - 9693 0700 – 0800 Hour SAN FRANCISCO TIME MaibachH@derm.ucsf.edu

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