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Life Extension Magazine

LE Magazine March 2003

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Medications side effects


References

1. Lazarou, J, Pomeranz, BH, Corey, PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998;279(15):1200-5.

2. Gilman, AG, Rall, TW, Nies, AS, Taylor, P. Goodman and Gilman's The Pharmacological Basis of Therapeutics. New York: Pergammon Press, 1990 and 1996.

3. Melmon, KL, Morrelli, HF, Hoffman, BB, Nierenberg, DW. Melmon and Morrelli's Clinical Pharmacology: Basic Principles in Therapeutics. (3rd Edition). New York: McGraw-Hill, Inc., 1993.

4. American Medical Association. AMA Drug Evaluations, Annual 1994. Chicago: American Medical Association, 1994.

5. Grady, D. Too Much of a Good Thing? Doctor Challenges Drug Manual. New York Times, Oct. 12, 1999:D1-2.

6. Wernicke, JF, Dunlop, SR, Dornseif, BE, Bosomworth, JC, Humbert, M. Low-dose fluoxetine therapy for depression. Psychopharmacology Bulletin 1988; 24(1):183-188.

7. Physicians' Desk Reference, 57th Edition. Montvale, N.J.: Medical Economics Company, 2003.

8. Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. JAMA 2001;285(19):2486-97.

9. Nowrocki, J, Weiss, S, et al. Reduction in LDL Cholesterol by 25% to 60% in Patients with Primary Hypercholesterolemia by Atorvastatin, a New HMG-Co-A Reductase Inhibitor. Arteriosclerosis, Thrombosis, and Vascular Biology 1995;15:678-682.

10. Wolffenbuttel, BH, Mahla, G, Muller, D, et al. Efficacy and safety of a new cholesterol synthesis inhibitor, atorvastatin, in comparison with simvastatin and pravastatin, in subjects with hypercholesterolemia. Netherlands Journal of Medicine 1998;52(4):131-7.

11. Bakker-Arkema, RG, Best, J, Fayyad, R, et al. A brief review paper of the efficacy and safety of atorvastatin in early clinical trials. Atherosclerosis 1997;131(1):17-23.

12. Cilla, DD Jr, Whitfield, LR, Gibson, DM, et al. Multiple-dose pharmacokinetics, pharmacodynamics, and safety of atorvastatin, an inhibitor of HMG-CoA reductase, in healthy subjects. Clinical Pharmacology and Therapeutics 1996;60(6):687-95.

13. Roberts, WC. The rule of 5 and the rule of 7 in lipid-lowering by statin drugs. American Journal of Cardiology 1997;80:106-7.

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16. Nonprescription Mevacor, FDA Advisory Committee Background Information, FDA Website, June 2000:www.fda. gov/ohrms/dockets/ac/00/backgrd/3622b1b.pdf.

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18. Carroll, DN, Roth, MT. Evidence for the cardioprotective effects of omega-3 fatty acids. Annals of Pharmacotherapy 2002;36:1950-1956.

19. GISSI-Prevenzione Investigators: Dietary supplementation with omega-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Lancet 1999;354:447-455.

20. Elliott, WJ, Maddy, R, Toto, R, Bakris, G. Hypertension in Patients with Diabetes. Postgraduate Medicine 2000;107:29-38.

21. Cohen, JS. Adverse drug effects, compliance, and the initial doses of antihypertensive drugs recommended by the Joint National Committee vs. the Physicians' Desk Reference. Archives of Internal Medicine 2001;161:880-85.

22. Wolfe, MM, Lichtenstein, DR, Singh, G. Gastrointestinal toxicity of nonsteroidal anti-inflammatory drugs. New England Journal of Medicine 1999;340(24):1888-99.

23. Chalmers TM. Clinical experience with ibuprofen in the treatment of rheumatoid arthritis. Annals of Rheumatic Diseases 1969;28:513-517.

24. Brooks CD, Schmid FR, Biundo J, et al. Ibuprofen and aspirin in the treatment of rheumatoid arthritis; a cooperative double-blind trial. Rheumatology and Physical Medicine 1970;10(suppl):48-63.

25. Thompson M, Bell D. Further experience with ibuprofen in the treatment of arthritis. Rheumatology and Physical Medicine 1970;10(suppl):100-103.

26. Hingorani, K. Double-blind crossover trial comparing ibuprofen with flufenamic acid in rheumatoid arthritis. Rheumatology and Physical Medicine 1970;10(suppl):76-82.

27. Durrigl, T, Vitaus, M, Pucar, I, Miko, M. Diclofenac sodium (Voltaren): Results of a multi-centre comparative trial in adult-onset rheumatoid arthritis. Journal of International Medical Research 1975;3:139-144.

28. Mutru O, Penttila M, Pesonen J, Salmela P, Suhonen O, Sonck T. Diclofenac sodium (Voltaren) and indomethacin in the ambulatory treatment of rheumatoid arthritis: A double-blind multicentre study. Scandinavian Journal of Rheumatology 1978;(suppl)22:51-56.

29. Ciccolunghi, SN, Chaudri, HA, Schubiger, BI. The value and results of long-term studies with diclofenac sodium (Voltarol). Rheumatology and Rehabilitation 1979;(suppl2):100-115.

30. Ciccolunghi, SN, Chaudri, HA, Schubiger, BI, Reddrop, R. Report on a long-term tolerability study of up to two years with diclofenac sodium (Voltaren). Scandinavian Journal of Rheumatology 1978;(suppl)22:86-96.

31. Bensen WG, Fiechtner JJ, McMillen JI, et al. Treatment of osteoarthritis with celecoxib: a randomized controlled trial. Mayo Clinic Proceedings 1999;74(11):1095-105.

32. Hall, SS. Claritin and Schering-Plough: a Prescription for Profit. New York Times, Mar. 11, 2001:www.nytimes.com.

33. Azarbal, B, Mirocha, J, Shah, PK, Cercek, B, Kaul, S. Adverse Cardiovascular Events Associated with the Use of Viagra. Journal of the American College of Cardiology 2000;35(SupplA):553A-554A. Abstract.

34. Cohen, JS. Should Patients Be Given a Low Test Dose of sildenafil (Viagra) Initially? Drug Safety 2000;23:1-10.

35. Digitalis: More Is Not Necessarily Better. Journal Of The American College Of Cardiology 1997;29:1206-13.

36. 57 Deaths in Britain associated with Zyban. Reuters Health, Jan. 10, 2002:www.reuters.com.

37. Associated Press. Inhaled steroids for asthma cause bone loss, study finds. San Diego Union-Tribune, Thurs., Sept. 27, 2001:A-14.

38. Recchia, AG, Shear, NH. Organization And Function Of An Adverse Drug Reaction Clinic. Journal Of Clinical Psychiatry, 1994; 34:68-79.

39. Smucker, WD, Kontak, JR. Adverse drug reactions causing hospital admission in an elderly population: experience with a decision algorithm. Journal of the American Board of Family Practice 1990;3(2):105-9.

40. Cheng H, Rogers JD, Sweany AE, et al. Influence of age and gender on the plasma profiles of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitory activity following multiple doses of lovastatin and simvastatin. Pharmaceutical Research 1992;9:1629-1633.

41. Williams, RD. Medications and older adults. FDA Consumer Magazine, Sept.-Oct. 1997.

42. Montamat, SC, Cusack, BJ, Vestal, RE. Management of drug therapy in the elderly. New England Journal of Medicine 1989;321(5):303-9.

43. Writing Group for the Women's Health Initiative. Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women. JAMA 2002;288:321-333.

44. Lacey, JV, Mink, PJ, Lubin, JH, Sherman, ME, Troisi, R, Hartge, P, et al. Menopausal hormone replacement therapy and risk of ovarian cancer. JAMA 2002;288:334-341.

45. Ettinger B. Personal perspective on low-dosage estrogen therapy for postmenopausal women. Menopause, 1999; 6(3):273-6.

46. Weinstein L. Efficacy of a continuous estrogen-progestin regimen in the menopausal patient. Obstetrics and Gynecology 1987;69(6):929-32.

47. Greendale, GA, Reboussin, BA, Hogan, P, et al. Symptom relief and side effects of postmenopausal hormones: results from the Postmenopausal Estrogen/Progestin Interventions Trial. Obstetrics and Gynecology 1998;92(6):982-8.

48. McNagny, SE. Prescribing Hormone Replacement Therapy for Menopausal Symptoms. Annals of Internal Medicine, 1999;131:605-16.

49. Snider S. The Pill: 30 Years of Safety Concerns. U.S. Food and Drug Administration, Dec. 1990;www.fda.gov/bbs/topics/CONSUMER/CON00027.html. Checked: Mar. 9, 2002.

50. Marks L. "Not just a statistic": The history of USA and UK policy over thrombotic disease and the oral contraceptive pill, 1960s-1970s. Social Science and Medicine 1999;49:1139-1155.

51. Vessey MP, Inman WH. Speculations about mortality trends from venous thromboembolic disease in England and Wales and their relation to the pattern of oral contraceptive usage. Obstetrics and Gynecology in the British Commonwealth 1973;80:562-566.

52. Bottiger LE, Boman G, Eklund G, Westerholm B. Oral contraceptives and thromboembolic disease: effects of lowering oestrogen content. Lancet 1980;1:1097-1101.

53. Shapiro, SS, Diem, K. The effects of ibuprofen in the treatment of dysmenorrhea. Current Therapeutic Research 1981;30(3):327-334.

54. Wierzbicki AS, Lumb PJ, Chik G, Crook MA. High-density lipoprotein cholesterol and triglyceride response with simvastatin versus atorvastatin in familial hypercholesterolemia. American Journal of Cardiology 2000;86:547-549.

55. Ose L, Luurila O, Eriksson J, Olsson A, Lithell H, Widgren B. Efficacy and safety of cerivastatin, 0.2 mg and 0.4 mg, in patients with primary hypercholesterolaemia: A multinational, randomised, double-blind study. Cerivastatin Study Group. Current Medical Research and Opinion 1999,15:228-240.

56. Peters TK, Muratti EN, Mehra M. Efficacy and safety of fluvastatin in women with primary hypercholesterolaemia. Drugs. 1994;47(Suppl2):64-72.

57. Leitersdorf E. Gender-related response to fluvastatin in patients with heterozygous familial hypercholesterolaemia. Drugs. 1994;47(Suppl 2):54-58.

58. Lewis CE. Characteristics and treatment of hypertension in women: a review of the literature. American Journal of the Medical Sciences 1996;311(4):193-9.

59. Israili, ZH, Hall, WD. Cough and angioneurotic edema associated with angiotensin-converting enzyme inhibitor therapy. A review of the literature and pathophysiology. Annals of Internal Medicine 1992;117(3):234-42.

60. Women Sufficiently Represented in New Drug Testing, but FDA Oversight Needs Improvement. Report to Congressional Requesters. US General Accounting Office, GAO-01-754, July 6, 2001:www.fda.gov/womens/informat.html.

61. Exploring the Biological Contributions to Human Health: Does Sex Matter? Wizemann, TM, Pardue, ML, Editors, Committee on Understanding the Biology of Sex and Gender Differences, Board on Health Sciences Policy, Institute of Medicine, National Academy of Sciences, National Academy Press, 2001.

62. Kritz, FL. Mars and Venus and Drugs: Sex Differences Create Extra Risks for Women. Washington Post, Feb. 20, 2001:T7.

63. Bowman, L. 51% Of U.S. Adults Take 2 Pills or More a Day, Survey Reports (Scripps Howard News Service). San Diego Union-Tribune, Jan. 17, 2001:A8.

64. Zuger, A. Caution: That dose may be too high. New York Times, September 17, 2002:nytimes.com.

65. Dorothy L. Smith, DTC Perspectives, Jan.-Feb. 2002.

66. Reuters Health. Medical Journals Act to Limit Drug Firms' Influence. Reuters, Sept. 10, 2001:www.reuters.com.

67. Davidoff, F, DeAngelis, CD, Drazen, JM, Hoey, J, Hojgaard, L, Horton, R, et al. Sponsorship, Authorship, and Accountability. New England Journal of Medicine, Sept. 13, 2001;345(11):825-27.

68. Schulman, KA, Seils, DM, Timbie, JW, Sugarman, J, et al. A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. New England Journal of Medicine 2002;347:1335-41.

69. Bodenheimer, T. Uneasy Alliance -- Clinical Investigators and the Pharmaceutical Industry. New England Journal of Medicine 2000;342:1539-44.

70. Herxheimer A. How much drug in the tablet? Lancet 1991;337:346-8.

71. Zuger, A. Caution: That dose may be too high. New York Times, September 17, 2002:nytimes.com.

72. Herxheimer, A. Dosage needs systematic and critical review. BMJ 2001;323.

73. Moore, TJ, Psaty, BM, Furberg, CD. Time to act on drug safety. JAMA 1998;279(19):1571-3.

74. Lasser, KE, Alan, PD, Woolhandler, SJ, Himmelstein, DU, Wolfe, SM, Bor, DH. Timing of New Black Box Warnings and Withdrawals for Prescription Medications. JAMA 2002;287:2215-2220.

75. Gaist, D, Jeppesen, U, Andersen, M, et al. Statins and the risk of polyneuropathy: a case-control study. Neurology 2002;58:1333-1337.

76. Avorn, J. The prescription as final common pathway. International Journal of Technology Assessment in Health Care 1995:11(3):384-90).

77. Wood, AJJ, Stein, CM, Woosley, R. Making Medicines Safer: the Need for An Independent Drug Safety Board. New England Journal of Medicine 1998;339:1851-54.

78. Young, SA. Is Academic Medicine for Sale? New England Journal of Medicine 2000;343:508.

79. Vollmann, J. Gifts to physicians from the pharmaceutical industry. JAMA 2000;283:2656-8.

80. Angell, M. Is Academic Medicine for Sale? New England Journal of Medicine 2000;342:1516-18:

81. Hensley, S. When doctors go to class, industry often foots the bill. Wall Street Journal, Dec. 4, 2002:A1.

82. Cimons, M. Scientists Study Gender Gap in Drug Responses. Los Angeles Times, Sun. June 6, 1999: A-1,8-9.

83. Angell, M, Relman, AS. Prescription for Profit. The Washington Post, June 20, 2001:A27.
84. Cohen, JS. The One-Size Dose Does Not Fit All: Look beyond the guidelines of drug manufacturers. Newsweek, Dec. 6, 1999:92.

85. American Medical Association Council on Ethical and Judicial Affairs. Code of Medical Ethics. 1998-1999 Edition. American Medical Association, Chicago, IL.

86. Top 10 Drugs of 2001. Pharmacy Times, Apr. 2002;68(4):10-15.


References for Table 1:

1. Clark, WG, Brater, DC, Johnson, AR. Goth's Medical Pharmacology. 13th Edition. St. Louis: The C.V. Mosby Company, 1992.

2. Gilman, AG, Rall, TW, Nies, AS, Taylor, P. Goodman and Gilman's The Pharmacological Basis of Therapeutics. New York: Pergammon Press, 1990 and 1996.

3. Martin, E.W. Hazards of Medication: A Manual on Drug Interactions, Contraindications, and Adverse Reactions with Other Prescribing and Drug Information. 2nd edition. Philadelphia: J.B. Lippincott Company, 1978.

4. American Medical Association. AMA Drug Evaluations, Annual 1994. Chicago: American Medical Association, 1994.

5. Herxheimer, A. Dosage needs systematic and critical review. BMJ 2001;323.

6. Heerdink, ER, Urquhart, J, Leufkens, HG. Changes in prescribed drug doses after market introduction. Pharmacoepidemiology and Drug Safety 2002;11:447-453.

7. Rowland, M, Sheiner, L, Steimer, J. Variability In Drug Therapy: Description, Estimation, And Control. A Sandoz Workshop. New York: Raven Press, New York, 1985.


References for Table 2:

1. Schatzberg AF, Dessain E, O'Neil P, Katz DL, Cole JO. Recent studies on selective serotonergic antidepressants: trazodone, fluoxetine, and fluvoxamine. Journal of Clinical Psychopharmacology 1987;7(6):44S-49S.

2. Wernicke, JF, Dunlop, SR, Dornseif, BE, Bosomworth, JC, Humbert, M. Low-dose fluoxetine therapy for depression. Psychopharmacology Bulletin 1988; 24(1):183-188.

3. Salzman C. Practical considerations in the pharmacologic treatment of depression in the elderly. Journal of Clinical Psychiatry 1990;59(1 Suppl):40-43.

4. Schatzberg AF. Dosing strategies for antidepressant agents. Journal of Clinical Psychiatry 1991:52(5suppl):14-20.

5. Cain, JW. Poor response to fluoxetine: underlying depression, serotonergic overstimulation, or a "therapeutic window"? Journal of Clinical Psychiatry 1992;53(8):272-277.

6. Louie, AK, Lewis, TB, Lannon, MD. Use of low-dose fluoxetine in major depression and panic disorder. Journal of Clinical Psychiatry 1993;54(1):435-438.

7. Rakel, RE. Conn's Current Therapy. Philadelphia: W.B. Saunders Company, 1993.

8. Gram, LF. Fluoxetine-review article. New England Journal of Medicine 1994;331:1354-61.


References for Table 5:

1. Tinkelman D, Falliers M, Bronsky E, et al. Efficacy and safety of fexofenadine in fall seasonal allergic rhinitis. Journal of Allergy and Clinical Immunology, 1996;97(1):1009.

2. Merlotti L, Roehrs T, Koshorek G, Zorick F, Lamphere J, Roth T. The dose effects of zolpidem on the sleep of healthy normals. Journal of Clinical Psychopharmacology 1989;9:9-14.

3. Cloud, ML, Offen, WW, Matsumoto, C. Healing and subsequent recurrence of duodenal ulcer in a clinical trial comparing nizatidine 300-mg and 100-mg evening doses and placebo in the treatment of active duodenal ulcer. Current Therapeutics and Research, Clinical Experience 1989;45(3):359-367.

4. Cohen MM, Clark L, Armstrong L, D'Souza J. Reduction of aspirin-induced fecal blood loss with low-dose misoprostol tablets in man. Digestive Diseases and Sciences, 1985;30(7):605-11.

5. Salkind MR, Silverstone T. A clinical and psychometric evaluation of flurazepam. British Journal of Clinical Pharmacology 1975;2:223-226.

6. Schatzberg AF, Dessain E, O'Neil P, Katz DL, Cole JO. Recent studies on selective serotonergic antidepressants: trazodone, fluoxetine, and fluvoxamine. Journal of Clinical Psychopharmacology 1987;7:44S-49S.

7. Mendels J, Johnston R, Mattes J, Riesenberg R. Efficacy and safety of b.i.d. doses of venlafaxine in a dose-response study. Psychopharmacology Bulletin 1993;29:169-174.

8. Roy, D, Dawling, S. Application of an individually predicted dosage of amitriptyline to the treatment of depression. International Clinical Psychopharmacology 1987;2:307-315.

9. Ettinger, B. Personal perspective on low-dosage estrogen therapy for postmenopausal women. Menopause, 1999; 6(3):273-6.

10. De Aloysio, D, Rovati, LC, Giacovelli, G, Setnikar, I, Bottiglioni, F. Efficacy on climacteric symptoms and safety of low dose estradiol transdermal matrix patches. Arzneimittel-Forschung 2000;50(3):293-300.

11. American Society of Hospital Pharmacists. American Hospital Formulary Service, Drug Information 1999. Gerald K. McEvoy, Editor. Bethesda: 1999.

12. Schatzberg AF. Dosing strategies for antidepressant agents. Journal of Clinical Psychiatry. 1991:52(Suppl5):14-20. Sjoqvist F, Bertilsson L. Clinical pharmacology of antidepressant drugs: Pharmacogenetics. Advances in Biochemistry and Psychopharmacology 1984,39:359-372.

13. Savarino, V, Mela, GS, Zentilin, P, Bonifacino, G, Moretti, M, et al. Low bedtime doses of H2-receptor antagonists for acute treatment of duodenal ulcers. Digestive Diseases and Sciences 1989;34(7):1043-46.

14. Lauritsen, K, Andersen, BN, Laursen, LS, Hansen, J, Havelund, T, Eriksen, J, et al. Omeprazole 20 mg three days a week and 10 mg daily in prevention of duodenal ulcer relapse; double-blind comparative trial. Gastroenterology 1991;100(3):663-9.

15. Rainer, MK, Masching, AJ, Ertl, MG, Kraxberger, E, Haushofer, M. Effect of risperidone on behavioral and psychological symptoms and cognitive function in dementia. Journal of Clinical Psychiatry 2001;62:894-900.

16. Elliott RL, Shillcutt SD. Using newer antidepressants in the medically ill: An update. Primary Psychiatry. 1996;3:42-56.

17. Rickels K, Schweizer E, Clary C, Fox I, Weise C. Nefazodone and imipramine in major depression: A placebo-controlled trial. British Journal of Psychiatry. 1994;164:802-805.

18. McCue R. Using tricyclic antidepressants in the elderly. Clinical Geriatric Medicine 1992;8:323-334.

19. Preskorn S. Pharmacokinetics of antidepressants: Why and how they are relevant to treatment. Journal of Clinical Psychiatry. 1993;54(suppl 9):14-34.

20. The Fifth Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Archives of Internal Medicine 1993;153:154-183.

21. Kirksey DF, Harto-Truax N. Private practice evaluation of the safety and efficacy of bupropion in depressed outpatients. Journal of Clinical Psychiatry. 1983;44:143-147.

22. Rossner S; Sjostrom L; Noack R; Meinders AE; Noseda G. Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years treatment with orlistat for obesity. European Orlistat Obesity Study Group. Obesity Research 2000;8:49-61.52.

23. Dobrilla, G, Barbara, L, Bianchi-Porro, G, Felder, M, Mazzacca, G, et al. Placebo Controlled Studies with Ranitidine in Duodenal Ulcer. Scandinavian Journal of Gastroenterology 1981;69(suppl):103-4.

24. Steinhagen-Thiessen E. Comparative efficacy and tolerability of 5 and 10 mg simvastatin and 10 mg pravastatin in moderate primary hypercholesterolemia. Simvastatin Pravastatin European Study Group. Cardiology, 1994, 85(3-4):244-54.

25. Tuomilehto J; Guimaraes AC; Kettner H; Lithell H; Pitkanen M; et al. Dose-response of simvastatin in primary hypercholesterolemia. Journal of Cardiovascular Pharmacology, 1994; 24(6):941-9.

26. Beck TM, Ciociola AA, Jones SE, et al. Efficacy of oral ondansetron in the prevention of emesis in outpatients receiving cyclophosphamide-based chemotherapy. Annals of Internal Medicine 1993;118:407-413.


References for Table 6:

1. Rochon, PA, Anderson, GM, Tu, JV, et al. Age- and gender-related use of low-dose drug therapy: the need to manufacture low-dose therapy and evaluate the minimum effective dose. Journal of the American Geriatrics Society, 1999 47(8):954-9.

2. Clark, WG, Brater, DC, Johnson, AR. Goth's Medical Pharmacology. 13th Edition. St. Louis: The C.V. Mosby Company, 1992.

3. Wolfe, SM, Hope, RE. Worst Pills, Best Pills II: The Older Adult's Guide to Avoiding Drug-Induced Death or Illness. Washington, D.C.: Public Citizen's Health Research Group, 1993.

4. Brawn, LA, Castleden, CM. Adverse drug reactions. An overview of special considerations in the management of the elderly patient. Drug Safety 1990;5(6):421-35.

5. Williams, RD. Medications and older adults. FDA Consumer Magazine, Sept.-Oct. 1997.

6. Everitt, DE, Avorn, J. Drug prescribing for the elderly. Archives of Internal Medicine 1986;146(12):2393-6.

7. Rochon, PA, Gurwitz, JH. Optimising drug treatment for elderly people: the prescribing cascade. BMJ 1997;315(7115):1096-9.

8. United States Pharmacopeia, Drug Information (USP DI): Drug Information for the Health Care Professional. Taunton, MA: Rand McNally, 1994.

9. Gibian T. Rational drug therapy in the elderly, or, how not to poison your elderly patients. Australian Family Physician 1992;21(12):1755-60.

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