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TOX LESSONS LEARNED: FOUR DECADES FDA DERMATOLOGY DRUGS WITHDRAWN HOWARD I. MAIBACH, M.D. PROFESSOR DEPARTMENT OF DERMATOLOGY UNIVERSITY OF CALIFORNIA.

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Presentation on theme: "TOX LESSONS LEARNED: FOUR DECADES FDA DERMATOLOGY DRUGS WITHDRAWN HOWARD I. MAIBACH, M.D. PROFESSOR DEPARTMENT OF DERMATOLOGY UNIVERSITY OF CALIFORNIA."— Presentation transcript:

1 TOX LESSONS LEARNED: FOUR DECADES FDA DERMATOLOGY DRUGS WITHDRAWN HOWARD I. MAIBACH, M.D. PROFESSOR DEPARTMENT OF DERMATOLOGY UNIVERSITY OF CALIFORNIA SAN FRANCISCO, CALIFORNIA 94143 – 0989 1

2 BIG PICTURE COMPLEXITY ! INCONSISTENCY SCIENCE IMPROVING CANCER : - ASSAY vs DISEASE 2

3 DISCLAIMER NEITHER SUPPORT NOR DENY THESE REGULATORY JUDGEMENTS 3

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

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

6 WITHDRAWALS – cont. 5) ZIRCONIUM – 1976 GRANULOMA 6)*K ARSENITE 1980 CANCER J. HUTCHINSON (100 YRS.) 7)BENOXAPROFEN 1982 RENAL & HEPATIC 8) CHLORHEXIDINE 1984 BURNS 6

7 WITHDRAWALS – cont. 9) TEMAFLOXACIN – 1992 RENAL & HEPATIC 10) ASTEMIZOLE – 1999 DRUG - DRUG INTERACTION 11) TERFENADINE – 1997 DRUG - DRUG INTERACTION 12) ETRETINATE – 2002 TERATOGENIC 7

8 WITHDRAWALS – cont. 13) EFALIZUMAB – 2009 PML (PROGRESSIVE MULTIFOCAL LUEKOENCEPHALOPATHY) CANCER: 2/13 8

9 BLACK BOX METHOTREXATELYMPHOMA TACROLIMUSLYMPHOMA PIMECROLIMUS CLINICAL RELEVANCE – SUB JUDICE 9

10 PACKAGE INSERT LABEL PHOTOCARCINOGENICITY - RETINOIC ACID - BENZOYL PEROXIDE CLINICAL RELEVANCE: SUB JUDICE 10

11 DERMATOLOGIC DRUGS ORAL / PARENTERAL ~ HALF – ANIMAL ASSAY + CLINICAL RELEVANCE: SUB JUDICE 11

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 12

13 WEAK LINKS PHARMACOVIGILENCE COSMETIC VIGILENCE CONSUMER PRODUCT VIGILENCE 13

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

15 REFERENCE M. MARTIN & H. MAIBACH: DERMATOLOGIC DRUGS WITHDRAWN BY THE FDA FOR SAFETY REASONS MARZULLI & MAIBACH: DERMATOTOXICOLOGY, 8 TH ED, INFORMA, 2012, p. 500-509 15

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


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