Drug withdrawals and the lessons within

Current Opinion in Drug Discovery and Development

Volumn 9, Issue 1, 2006, Pages 38-46

  Smith, Dennis A ^a   Schmid, Esther F ^a  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

Pharmacology; Primary; Screening; Secondary; Toxicity

Indexed keywords

ALOSETRON; ASTEMIZOLE; BENOXAPROFEN; BROMFENAC; CERIVASTATIN; CISAPRIDE; DEXFENFLURAMINE; DIETHYLSTILBESTROL; DRUG; ENCAINIDE; FENFLURAMINE; FLOSEQUINAN; GREPAFLOXACIN; MIBEFRADIL; NOMIFENSINE; PARACETAMOL; RAPACURONIUM BROMIDE; REMOXIPRIDE; ROFECOXIB; SIMVASTATIN; SUPROFEN; TEMAFLOXACIN; TERFENADINE; THALIDOMIDE; TIENILIC ACID; TOLCAPONE; TROGLITAZONE; TROVAFLOXACIN; UNINDEXED DRUG; ZOMEPIRAC;

ALLERGIC DISEASE; ANGIOGENESIS; BRONCHOSPASM; CARCINOGENICITY; CELL DEATH; CONSTIPATION; DIGESTIVE SYSTEM ULCER; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG MARKETING; DRUG MEGADOSE; DRUG METABOLISM; DRUG STRUCTURE; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; FECES IMPACTION; GASTROINTESTINAL HEMORRHAGE; HEART ARRHYTHMIA; HEART FAILURE; HUMAN; HYPERTENSION; IRRITABLE COLON; ISCHEMIC COLITIS; KIDNEY FAILURE; LIVER TOXICITY; MACROMOLECULE; MORTALITY; MOUSE; MYOPATHY; NONHUMAN; OBESITY; OXIDATIVE STRESS; PULMONARY HYPERTENSION; QT PROLONGATION; REVIEW; RHABDOMYOLYSIS; STABLE ANGINA PECTORIS; STEADY STATE; SYSTEMATIC REVIEW; TERATOGENICITY; TORSADE DES POINTES; VALVULAR HEART DISEASE;

ANIMALS; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; CARBOLINES; COLITIS, ISCHEMIC; DRUG DESIGN; DRUG TOXICITY; FENFLURAMINE; HEART VALVE DISEASES; HUMANS; LIVER DISEASES; PRODUCT SURVEILLANCE, POSTMARKETING; PROPIONIC ACIDS; SEROTONIN AGENTS; SEROTONIN ANTAGONISTS;

EID: 30744431644     PISSN: 13676733     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (41)

1. Wysowski DK, Swartz L: Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: The importance of reporting suspected reactions. Arch Intern Med (2005) 165(12):1363-1369. Provides a comprehensive listing of drug withdrawals. Despite their importance no single database is available that captures drugs withdrawn from international markets, with their reasons for withdrawal.
2. Newbold RR: Lessons learned from perinatal exposure to diethylstilbestrol. Toxicol Appl Pharmacol (2004) 199(2):142-150.
3. Hansen JM, Harris C: A novel hypothesis for thalidomide-induced limb teratogenesis: Redox misregulation of the NF-κB pathway. Antiox Redox Signal (2004) 6(1):1-14.
4. Meierhofer C, Dunzendorfer S, Wiedermann C: Theoretical basis for the activity of thalidomide. BioDrugs (2001) 15(10):681-703.
5. Camilleri M: Pharmacology and clinical experience with alosetron. Exp Opin Invest Drugs (2000) 9(1):147-159.
6. Beck IT: Possible mechanisms for ischemic colitis during alosetron therapy. Gastroenterology(2001) 121(1):231-232.
7. Jamal SM, Eisenberg MJ, Christopoulos S: Rhabdomyolysis associated with hydroxymethylglutanyl-coenzyme A reductase inhibitors. Am Heart J (2004) 147(6):956-985.
8. Moe GW, Rouleau JL, Charbonneau L, Prouix G, Arnold MO, Hall C, de Champlain J, Barr A, Sirois P, Packer M: Neurohormonal activation in severe heart failure: Relations to patient death and the effect of treatment with flosequinan. Am Heart J (2000) 139(4):587-595.
9. Falotico R, Haertein BJ, Lakas-Weiss CS, Salata JJ, Tobia AJ: Positive inotropic and hemodynamic properties of flosequinan, a new vasodilator, and a sulfone metabolite. J Cardiovasc Pharmacol (1989) 14(3):412-418.
10. Gristwood RW, Beleta J, Bou J, Cardelus I, Fernandez AG, Llenas J, Berga P: Studies on the cardiac actions of flosequinan in vitro. Br J Pharmacol (1992) 105(4):985-991.
11. Nicholls DP, Droogan A, Carson CA, Taylor IC, Passmore AP, Johnston GD, Kendall M, Dutka D, Morris GK, Underwood LM, Hind ID: Pharmacokinetics of flosequinan in patients with heart failure. Eur J Clin Pharmacokinet (1996) 50(4):289-291.
12. Lazzara R: From first class to third class: Recent upheaval in antiarrythmic therapy - lessons from clinical trials. Am J Cardiol (1996) 78(4A):28-33.
13. Casturi SR, Hegde P, Ramanujam R: Development of COX-2 selective inhibitors - therapeutic perspectives. Curr Med Chem - Immunol Endocrin Metab Agents (2005) 5(3):241-248.
14. 2B receptors in the cardiopathy associated with fenfluramine. Mol Pharmacol (2000) 57(1):75-81.
15. 2B receptors in cardiac valvulopathy associated with fenfluramine and other serotonergic medications. Circulation (2000) 102(23):2836-2841.
16. 3 muscarinic receptors in guinea pig airway smooth muscle. Anesthiology (2005) 102(1):117-124.
17. Jooste E, Klafter F, Hirshman CA, Emala CW: A mechanism for rapacuronium-induced bronchospasm. Anesthiology (2003) 98(4):906-911.
18. Redfern WS, Carlsson L, Davis AS, Lynch WG, MacKenzie I, Palethorpe S, Siegl PK, Strang I, Sullivan AT, Wallis R, Camm AJ et al: Relationship between preclinical electrophysiology, clinical QT interval prolongation and torsade de pointes for a broad range of drugs: Evidence for a provisional safety margin in drug development Cardiovasc Res (2003) 58(1):32-45. Provides a detailed analysis of the scientific understanding of the risk of prolonged QT interval, along with drugs and screening methods to mitigate the risk.
19. Welker HA, Wiltshire H, Bullingham R: Clinical pharmacokinetics of mibefradil. Clin Pharmacokinet (1998) 35(6):405-423.
20. Prueksaritanont T, Ma B, Tang C, Meng Y, Assang C, Lu P, Reider PJ, Lin JH, Baillie TA: Metabolic interactions between mibefradil and HMG-CoA reductase inhibitors: An in vitro investigation with human liver preparations. Br J Clin Pharm (1999) 47(3):291-298.
21. Zolotoy AB, Plouvier BP, Beatch GB, Hayes ES, Wall RA, Walker MJ: Physicochemical determinants for drug-induced blockade of HERG potassium channels: Effect of charge and charge shielding. Curr Med Chem-Cardiovasc Hematol Agents (2003) 1(3):225-241.
22. Wible BA, Hawryluk P, Ficker E, Kuryshev YA, Kirsch G, Brown AM: HERG-Lite: A novel comprehensive high-throughput screen for drug-induced HERG risk. J Pharmacol Toxicol Methods (2005) 52(1):136-145.
23. Lim HK, Duczak N Jr, Brougham L, Elliot M, Patel K, Chan K: Automated screening with confirmation of mechanism-based inactivation of CYP3A4, CYP2C9, CYP206 and CYP1A2 in pooled human liver microsomes. Drug Metab Dispos (2005) 33(8):1211-1219.
24. Smith DA, Obach RS: Seeing through the MIST: Abundance versus percentage. Commentary on metabolites in safety testing. Drug Metab Dispos (2005) 33(10):1409-1417. Provides a scientific rationale for investigating metabolites based on concentration and mass rather than percentage
25. Abraham PA, Halstenson CE, Opsahl JA, Matzke GR, Keane WF: Suprofen-induced uricosuria. A potential mechanism for acute nephropathy and flank pain. Am J Nephrol (1988) 8(2):90-95.
26. Li AP: A review of the common properties of drugs with idiosyncratic hepatotoxicity and the "multiple determinant hypothesis" for the manifestation of idiosyncratic drug toxicity. Chem-Biol Interact (2002) 142(1-2):7-23.
27. Kalgutkar AS, Gardner I, Obach RS, Shatter CL, Callegari E, Henne KR, Mutlib AE, Dalvie DK, Lee JS, Nakai Y, O'Donnell JP et al: A comprehensive listing of bioactivation pathways of organic functional groups. Curr Drug Metab (2005) 6(3):161-225. Comprehensive review of the chemistry behind the formation of reactive metabolites and the susceptibility of key chemical groupings.
28. Nelson SD: Structure toxicity relationships - how useful are they in predicting toxicities of new drugs? Adv Exp Med Biol (2001) 500:33-43.
29. Uetrecht J: Screening for the potential of a drug candidate to cause idiosyncratic drug reactions. Drug Disc Today (2003) 8(18):832-837.
30. Castro-Perez J, Plumb R, Liang L, Yang E: A high-throughput liquid chromatography/tandem mass spectrometry method for screening glutathione conjugates using exact mass neutral loss acquisition. Rapid Commun Mass Spectrum (2005) 19(6):798-804.
31. Evans CA, Fries HE, Ward KW: In vitro metabolic fate of a novel structural class: Evidence for the formation of a reactive intermediate on a benzothiophene moiety. Chem-Biol Interact (2005) 152(1):25-36.
32. Spahn-Langguth H, Dahms M, Hermening A: Acyl glucuronides. Covalent binding and its potential relevance. Adv Exp Med Biol (1996) 387:313-328.
33. Bolze S, Bromet N, Gay-Feutry C, Massiere F, Boulieu R, Hulot T: Development of an in vitro screening model for the biosynthesis of acyl glucuronide metabolites and the assessment of their reactivity toward human serum albumin. Drug Metab Dispos (2002) 30(4):404-413.
34. Dong JQ, Liu J, Smith PC: Role of benoxaprofen and flunoxaprofen acyl glucuronides in covalent binding to rat plasma and liver proteins in vivo. Biochem Pharmacol (2005) 70(6):937-948.
35. Williams DP, Garcia-Allan C, Hanton G, LeNet JL, Provost JP, Brain P, Welsh R, Johnston GI, Smith DA, Park BK: Time course toxicogenomic profiles in CD-1 mice after non-toxic and non lethal paracetamol administration. Chem Res Toxicol (2004) 17(12):1551-1561.
36. Liguori MJ, Anderson LM, Bukofzer S, McKim J, Pregenzer JF, Retief J, Spear BB, Waring JF: Microarray analysis in human hepatocytes suggests a mechanism for hepatotoxicity Induced by trovafloxacin. Hepatology (2005) 41(1):177-186.
37. Inayat-Hussain SH, McGuinness SM, Johansson R, Lundstrom J, Ross D: Caspase-dependent and -independent mechanisms in apoptosis induced by hydroquinone and catechol metabolites of remoxipride in HL-60 cells. Chem-Biol Interact (2000) 128(1):51-63.
38. Erve JC, Svensson MA, von Euler-Chelpin H, Klasson-Wehler E: Characterization of glutathione conjugates of the remoxipride hydroquinone metabolite NCQ-344 formed in vitro and detection following oxidation by human neutrophils. Chem Res Toxicol (2004) 17(4):564-571.
39. Nilsson LB: High sensitivity determination of the remoxipride hydroquinone metabolite NCQ-344 in plasma by coupled column reversed-phase liquid chromatography and electrochemical detection. Biomed Chromatogr(1998) 12(2):65-68.
40. McGuinness SM, Johansson R, Lundstrom J, Ross D: Induction of apoptosis by remoxipride metabolites in HL60 and CD34+/CD19-human bone marrow progenitor cells: Potential relevance to remoxipride-induced aplastic anemia. Chem-Biol Interact (1999) 121(3):253-265.
41. O'Donnell JP, Dalvie DK, Kalgutkar AS, Obach RS: Mechanism-based inactivation of human recombinant P450 2C9 by the nonsteroidal anti-inflammatory drug suprofen. Drug Metab Dispos (2003) 31(11):1369-1377.