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Preventable Adverse Drug Reactions:
A Focus on Drug Interactions - References


Celebrex. Physicians’ Desk Reference. Montvale, NJ: Medical Economics Company, Inc.; 2001:2482–2485.

Prilosec. Physicians’ Desk Reference. Montvale, NJ: Medical Economics Company, Inc.; 2001:587–591.

Aklillu E, Persson I, Bertilsson L, Johansson I, Rodrigues F, Ingelman-Sundberg M. Frequent distribution of ultrarapid metabolizers of debrisoquine in an ethiopian population carrying duplicated and multiduplicated functional CYP2D6 alleles. J Pharmacol Exp Ther 1996; 278(1):441–446.

American Society of Health Systems Pharmacists. ASHP Patient Concerns National Survey Research Report. 1999. Bethesda, MD.

Atiba JO, Blaschke TF, Wilkinson GR. Effects of ketoconazole on the polymorphic 4-hydroxylations of S-mephenytoin and debrisoquine. Br J Clin Pharmacol 1989; 28(2):161–165.

Bailey DG, Spence JD, Munoz C, Arnold JM. Interaction of citrus juices with felodipine and nifedipine. Lancet 1991;337(8736):268–269.

Bates DW, Leape LL, Cullen DJ, Laird N, Petersen LA, Teich JM, et al. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA 1998;280(15):1311–1316.

Bergstrom RF, Peyton AL, Lemberger L. Quantification and mechanism of the fluoxetine and tricyclic antidepressant interaction. Clin Pharmacol Ther 1992;51(3):239–248.

Black DJ, Kunze KL, Wienkers LC, Gidal BE, Seaton TL, McDonnell ND, et al. Warfarin-fluconazole. II. A metabolically based drug interaction: in vivo studies. Drug Metab Dispos 1996;24(4):422–428.

Branch RA, Adedoyin A, Frye RF, Wilson JW, Romkes M. In vivo modulation of CYP enzymes by quinidine and rifampin. Clin Pharmacol Ther 2000;68(4):401–411.

Breidenbach T, Hoffmann MW, Becker T, Schlitt H, Klempnauer J. Drug interaction of St John’s wort with cyclosporin. Lancet 2000; 355(9218):1912.

Brouwer KLR, Dukes GE, Powell JR. Influence of liver function on drug disposition. In: Evans WE, Schentag JJ, Jusko WJ, editors. Applied Pharmacokinetics: Principles of Therapeutic Drug Monitoring. Vancouver, WA: Applied Therapeutics, Inc.; 1992:6-1–6-59.

Cadle RM, Zenon GJ, III, Rodriguez-Barradas MC, Hamill RJ. Fluconazole-induced symptomatic phenytoin toxicity. Ann Pharmacother 1994;28(2):191–195.

Caraco Y, Sheller J, Wood AJ. Pharmacogenetic determination of the effects of codeine and prediction of drug interactions. J Pharmacol Exp Ther 1996;278(3):1165–1174.

Cavuto NJ, Woosley RL, Sale M. Pharmacies and prevention of potentially fatal drug interactions. JAMA 1996;275:1086–1087.

Chyka PA, McCommon SW. Reporting of adverse drug reactions by poison control centres in the US. Drug Saf 2000;23(1):87–93.

Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA 1997; 277(4):301–306.

Committee on Quality of Health Care in America: Institute of Medicine. To err is human: building a safer health system. Washington, D.C.: National Academy Press;

Desta Z, Soukhova NV, Flockhart DA. Inhibition of cytochrome P450 (CYP450) isoforms by isoniazid: potent inhibition of CYP2C19 and CYP3A. Antimicrob Agents Chemother 2001;45(2):382–392.

Dresser GK, Bailey DG, Carruthers SG. Grapefruit juice–felodipine interaction in the elderly. Clin Pharmacol Ther 2000;68(1):28–34.

Eland IA, Belton KJ, van Grootheest AC, Meiners AP, Rawlins MD, Stricker BH. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999;48(4):623–627.

Evans RS, Pestotnik SL Classen DC, Horn SD, Bass SB, Burke JP. Preventing adverse drug events in hospitalized patients. Ann Pharmacother 1994;28(4):523–527.

Figueiras A, Tato F, Fontainas J, Gestal-Otero JJ. Influence of physicians’ attitudes on reporting adverse drug events: a case-control study. Med Care 1999;37(8):809–814.

Friedman MA, Woodcock J, Lumpkin MM, Shuren JE, Hass AE, Thompson LJ. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA 1999;281(18):1728–1734.

Furuta T, Ohashi K, Kamata T, Takashima M, Kosuge K, Kawasaki T et al. Effect of genetic differences in omeprazole metabolism on cure rates for Helicobacter pylori infection and peptic ulcer. Ann Intern Med 1998; 129(12):1027–1030.

Furuta T, Shirai N, Takashima M, Xiao F, Hanai H, Sugimura H et al. Effect of genotypic differences in CYP2C19 on cure rates for Helicobacter pylori infection by triple therapy with a proton pump inhibitor, amoxicillin,and clarithromycin. Clin Pharmacol Ther 2001; 69(3):158–168.

Gebhart F. VA facility slashes drug errors via bar-coding. Drug Topics 1999;1:44.

Ghoneim MM, Korttila K, Chiang CK, Jacobs L, Schoenwald RD, Mewaldt SP et al. Diazepam effects and kinetics in Caucasians and Orientals. Clin Pharmacol Ther 1981;29(6):749–756.

Grasela TH, Jr, Dreis MW. An evaluation of the quinolone-theophylline interaction using the Food and Drug Administration spontaneous reporting system. Arch Intern Med 1992;152(3):617–621.

Gurwitz JH, Field TS, Avorn J, McCormick D, Jain S, Eckler M et al. Incidence and preventability of adverse drug events in nursing homes. Am J Med 2000;109(2):87–94.

Ishizaki T, Chiba K, Manabe K, Koyama E, Hayashi M, Yasuda S, et al. Comparison of the interaction potential of a new proton pump inhibitor,E3810,versus omeprazole with diazepam in extensive and poor metabolizers of S-mephenytoin 4’-hydroxylation. Clin Pharmacol Ther 1995;58(2):155–164.

Jacubeit T, Drisch D, Weber E. Risk factors as reflected by an intensive drug monitoring system. Agents Actions 1990;29:117–125.

Johne A, Brockmoller J, Bauer S, Maurer A, Langheinrich M, Roots I. Pharmacokinetic interaction of digoxin with an herbal extract from St John’s wort (Hypericum perforatum). Clin Pharmacol Ther 1999;66(4):338–345.

Johnson JA, Bootman JL. Drug-related morbidity and mortality. A cost-of-illness model. Arch Intern Med 1995;155(18):1949–1956.

Kane GC, Lipsky JJ. Drug-grapefruit juice interactions. Mayo Clin Proc 2000;75(9): 933–942.

Kessler DA. Introducing MedWatch. A new approach to reporting medication and device adverse effects and product problems. JAMA 1993;269(21):2765–2768.

Ko JW, Sukhova N, Thacker D, Chen P, Flockhart DA. Evaluation of omeprazole and lansoprazole as inhibitors of cytochrome P450 isoforms. Drug Metab Dispos 1997;25(7): 853–862.

Lam YW, Banerji S, Hatfield C, Talbert RL. Principles of drug administration in renal insufficiency. Clin Pharmacokinet 1997; 32(1):30–57.

Lazarou J, Pomeranz B, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA 1998; 279(15):1200–1205.

Leape LL, Bates DW, Cullen DJ, Cooper J, Demonaco HJ, Gallivan T et al. Systems analysis of adverse drug events. ADE Prevention Study Group. JAMA 1995;274(1):35–43.

Leape LL, Brennan TA, Laird N, Lawthers AG, Localio AR, Barnes BA et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med 1991;324(6):377–384.

Leucht S, Hackl HJ, Steimer W, Angersbach D, Zimmer R. Effect of adjunctive paroxetine on serum levels and side-effects of tricyclic antidepressants in depressive inpatients. Psychopharmacology (Berl) 2000;147(4):378–383.

Lown KS, Bailey DG, Fontana RJ, Janardan SK, Adair CH, Fortlage LA et al. Grapefruit juice increases felodipine oral availability in humans by decreasing intestinal CYP3A protein expression. J Clin Invest 1997;99(10):2545–2553.

Monahan BP, Ferguson CL, Killeavy ES, Lloyd BK, Troy J, Cantilena LR. Torsade de pointes occurring in association with terfenadine use. JAMA 1990;264:2788–2790.

National Association of Chain Drug Stores. 2000 community pharmacy results. 2001. Alexandria, VA.

Pieper JA, Johnson KE. Lidocaine. In: Evans WE, Schentag JJ, Jusko WJ, editors. Applied Pharmacokinetics: Principles of Therapeutic Drug Monitoring. Vancouver, WA: Applied Therapeutics, Inc.; 1992:21-1–21-37.

Piscitelli SC, Burstein AH, Chaitt D, Alfaro RM, Falloon J. Indinavir concentrations and St John’s wort. Lancet 2000;355(9203):547–548.

Pokrajac M, Simic D, Varagic VM. Pharmacokinetics of theophylline in hyperthyroid and hypothyroid patients with chronic obstructive pulmonary disease. Eur J Clin Pharmacol 1987;33(5):483–486.

Prichard PJ, Walt RP, Kitchingman GK, Somerville KW, Langman MJ, Williams J, et al. Oral phenytoin pharmacokinetics during omeprazole therapy. Br J Clin Pharmacol 1987;24(4):543–545.

Raaska K, Neuvonen PJ. Ciprofloxacin increases serum clozapine and N-desmethyl-clozapine:a study in patients with schizophrenia. Eur J Clin Pharmacol 2000;56(8):585–589.

Raschetti R, Morgutti M, Menniti-Ippolito F, Belisari A, Rossignoli A, Longhini P, et al. Suspected adverse drug events requiring emergency department visits or hospital admissions. Eur J Clin Pharmacol 1999;54(12):959–963.

Rosenblat R, Tang SW. Do Oriental psychiatric patients receive different dosages of psychotropic medication when compared with occidentals. Can J Psychiatry 1987;32(4):270–274.

Ruschitzka F, Meier PJ, Turina M, Luscher TF, Noll G. Acute heart transplant rejection due to Saint John’s wort. Lancet 2000; 355(9203):548–549.

Schappert SM. Ambulatory care visits to physician offices, hospital outpatient departments,and emergency departments: United States, 1997. 13(143). 1999. National Center for Health Statistics. Vital Health Stat. 1999; 13(143).

Shammas FV, Dickstein K. Clinical pharmacokinetics in heart failure. An updated review.  Clin Pharmacokinet 1988;15(2):94–113.

Shimada T, Yamazaki H, Mimura M, Inui Y, Guengerich FP. Interindividual variations in human liver cytochrome P-450 enzymes involved in the oxidation of drugs, carcinogens and toxic chemicals: studies with liver microsomes of 30 Japanese and 30 Caucasians.  J Pharmacol Exp Ther 1994;270(1):414–423.

Shin JG, Kane K, Flockhart DA. Potent inhibition of CYP2D6 by haloperidol metabolites: stereoselective inhibition by reduced haloperidol. Br J Clin Pharmacol 2001;51(1):45–52.

Shin JG, Soukhova N, Flockhart DA. Effect of antipsychotic drugs on human liver cytochrome P-450 (CYP) isoforms in vitro: preferential inhibition of CYP2D6. Drug Metab Dispos 1999;27(9):1078–1084.

Smalley W, Shatin D, Wysowski DK, Gurwitz J, Andrade SE, Goodman M, et al. Contraindicated use of cisapride: impact of food and drug administration regulatory action. JAMA 2000;284(23):3036–3039.

Stephens MA, Self TH, Lancaster D, Nash T. Hypothyroidism: effect on warfarin anticoagulation. South Med J 1989;82(12):1585–1586.

Thummel KE, Wilkinson GR. In vitro and in vivo drug interactions involving human CYP3A. Annu Rev Pharmacol Toxicol 1998; 38:389–430.

Touchette MA, Chandrasekar PH, Milad MA, Edwards DJ. Contrasting effects of fluconazole and ketoconazole on phenytoin and testosterone disposition in man. Br J Clin Pharmacol 1992;34(1):75–78.

Williams L, Davis JA, Lowenthal DT. The influence of food on the absorption and metabolism of drugs. Med Clin N Am 1993; 77(4):815–829.

Woosley RL, Chen Y, Freiman JP, Gillis RA. Mechanism of the cardiotoxic actions of terfenadine. JAMA 1993;269(12):1532–1536.

Yamaguchi A, Tateishi T, Okano Y, Matuda T, Akimoto Y, Miyoshi T, et al. Higher incidence of elevated body temperature or increased C-reactive protein level in asthmatic children showing transient reduction of theophylline metabolism. J Clin Pharmacol 2000; 40(3):284–289.

Zevin S, Benowitz NL. Drug interactions with tobacco smoking. An update. Clin Pharmacokinet 1999;36(6):425–438.


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