Male/female differences in pharmacology: Safety issues with QT-prolonging drugs

Journal of Women's Health

Volumn 14, Issue 1, 2005, Pages 47-52

  Anthony, Marietta ^a,b  

^a UNIVERSITY OF ARIZONA   (United States)

^b UNIVERSITY OF ARIZONA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ALOSETRON; AMIODARONE; ANTIARRHYTHMIC AGENT; ANTIBIOTIC AGENT; ANTIHISTAMINIC AGENT; ASTEMIZOLE; BEPRIDIL; CISAPRIDE; CORTICOSTEROID; CYCLOSPORIN; DEXFENFLURAMINE; DIETHYLSTILBESTROL; DISOPYRAMIDE; DROPERIDOL; ERYTHROMYCIN; FENFLURAMINE; GREPAFLOXACIN; IBUPROFEN; IBUTILIDE; NEUROLEPTIC AGENT; PROBUCOL; QUINIDINE; SERTINDOLE; SOTALOL; TERFENADINE; THALIDOMIDE; TROGLITAZONE; UNINDEXED DRUG; VERAPAMIL;

DRUG CLEARANCE; DRUG EFFICACY; DRUG INDUCED DISEASE; DRUG SAFETY; EMBRYOPATHY; ETHNIC DIFFERENCE; FEMALE; HEART ARRHYTHMIA; HUMAN; IN VITRO STUDY; IN VIVO STUDY; LONG QT SYNDROME; MALE; PAIN; PHARMACODYNAMICS; PREDICTION; PRIORITY JOURNAL; RACE DIFFERENCE; REVIEW; SEX DIFFERENCE; STROKE; TORSADE DES POINTES; VAGINA CARCINOMA;

EID: 14644390358     PISSN: 15409996     EISSN: None     Source Type: Journal    
DOI: 10.1089/jwh.2005.14.47     Document Type: Review

References (59)

1. Institute of Medicine (U.S.). Committee on Understanding the Biology of Sex and Gender Differences. Exploring the biological contributions to human health: Does sex matter? Washington, DC: National Academy Press, 2001.
2. Anthony M, Berg MJ. Biologic and molecular mechanisms for sex differences in pharmacokinetics, pharmacodynamics, and pharmacogenetics: Part II. J Wom Health Gender-Based Med 2002;117:617.
3. Food and Drug Administration. Guideline for the format and content of the clinical and statistical sections of new drug applications. Federal Register. Rockville, MD: FDA, 1988, FR 39524.
4. Chen ML, Lee SC, Ng MJ, Schuirmann DJ, Lesko LJ, Williams RL. Pharmacokinetic analysis of bioequivalence trials: Implications for sex-related issues in clinical pharmacology and biopharmaceutics. Clin Pharmacol Ther 2001;68:510.
5. Lenz W, Knapp K. Die Thalidomid-Embryopathie. Dtsch Med Wochenschr 1962;87:1232.
6. Larsen A, Hole LW, Mackenzie B. Congenital deformities associated with the use of thalidomide during pregnancy, British Columbia, 1961-62. Can J Public Health 1963;54:505.
7. Kelsey FO. Thalidomide update: Regulatory aspects. Teratology 1988;38:221.
8. Herbst AL, Green TH Jr. Ulfelder H. Primary carcinoma of the vagina. An analysis of 68 cases. Am J Obstet Gynecol 1970;106:210.
9. Herbst AL, Ulfelder H, Poskanzer DC. Adenocarcinoma of the vagina. Association of maternal stilbestrol therapy with tumor appearance in young women. N Engl J Med 1971;284:878.
10. Ulfelder H, Poskanzer D, Herbst AL. Stilbestroladenosis-carcinoma syndrome: Geographic distribution. N Engl J Med 1971;285:691.
11. Food and Drug Administration. General considerations for the clinical evaluation of drugs. Washington, DC: FDA, 1977. Publication No. HEW (FDA) 77-3040.
12. Food and Drug Administration. Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs: Notice. Federal Register. Rockville, MD: FDA, 1993. Docket No. 93D-0236: 39406-39416.
13. Merkatz R, Temple R, Sobel S, Feiden K, Kessler DA. Women in clinical trials of new drugs: A change in Food and Drug Administration policy. N Engl J Med 1993;329:292.
14. U.S. General Accounting Office. Women's health. Women sufficiently represented in new drug testing, but FDA oversight needs improvement. Washington, DC: GAO, 2001. GAO-01-754.
15. Evelyn B, Toigo T, Banks D. Women's participation in clinical trials and gender-related labeling: A review of new molecular entities approved 1995-1999. Washington, DC: U.S. Food and Drug Administration, Office of Special Health Issues, Office of International and Constituent Relations, office of the Commissioner, 2001. Available from www.fda.gov/cder/reports/womens_health/women_clin_trials.htm.
16. Gruber M. Participation of females in clinical trials and gender analysis of data in biologic product applications. Available from www.fda.gov/cber/clinical/femclin.htm.
17. Harris RZ, Benet LZ, Schwartz JB. Gender effects in pharmacokinetics and pharmacodynamics. Drugs 1995; 50:222.
18. Schwartz JB. The influence of sex on pharmacokinetics. Clin Pharmacokinet 2003;42:107.
19. Huang S-M, Miller M, Toigo T, et al. Evaluation of drugs in women: Regulatory perspective In: Legato MJ, ed. Principles of gender-specific medicine. San Diego, CA: Elsevier Academic Press, 2004:848.
20. Hardman JG, Limbird LE, Molinoff PB, Ruddon RW, Gilman AG, eds. Goodman and Gilman's pharmacologial basis of therapeutics, 10th ed. New York: McGraw-Hill, 2001.
21. Spranger M, Aspey BS, Harrison MJ. Sex differences in antithrombotic effect of aspirin. Stroke 1989;20:34.
22. Hulst LK, Fleishaker JC, Peters GR, Harry JD, Wright DM, Ward P. Effect of age and gender on tirilazad pharmacokinetics in humans. Clin Pharmacol Ther 1994;55:378.
23. Walker J, Carmody JJ. Experimental pain in healthy human subjects: Gender differences in nociception and a response to ibuprofen. Anesth Analg 1998;86: 1257.
24. Lew KH, Ludwig EA, Milad MA, et al. Gender-based effects on methylprednisolone pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther 1993;54: 402.
25. U.S. General Accounting Office. Drug safety: Most drugs withdrawn in recent years had greater health risks for women. Washington, DC: GAO, 2001. GAO-01-286R Drugs withdrawn from market.
26. Makkar RR, Fromm BS, Steinman RT, Meissner MD, Lehmann MH. Female gender as a risk factor for torsades de pointes associated with cardiovascular drugs. JAMA 1993;270:2590.
27. Woosley RL. Drugs that prolong the QT interval and/or induce torsades de pointes. Tucson, AZ: University of Arizona, 2000. Available from: qtdrugs.org.
28. Roden DM. Drug therapy: Drug-induced prolongation of the QT interval. N Engl J Med 2004;350:1013.
29. Drici MD, Knollmann BC, Wang WX, Woosley RL. Cardiac actions of erythromycin: Influence of female sex. JAMA 1998;280:1774.
30. Wesche DL, Schuster BG, Wang WX, Woosley RL. Mechanism of cardiotoxicity of halofantrine. Clin Pharmacol Ther 2000;67:521.
31. Woosley RL, Chen Y, Freiman JP, Gillis RA. Mechanism of the cardiotoxic actions of terfenadine. JAMA 1993;269:1532.
32. Drici MD, Wang WX, Liu XK, Woosley RL, Flockhart DA. Prolongation of QT interval in isolated feline hearts by antipsychotic drugs. J Clin Psychopharmacol 1997;18:477.
33. Benton RE, Sale M, Flockhart DA, Woosley RL. Greater quinidine-induced QTc interval prolongation in women. Clin Pharmacol Ther 2000;67:413.
34. Hossein S, Nguyen M, Shenasa M. Proarrhythmic effect of ibutilide: A two center report. Supplement to Circulation 1997;96:I-383 (Abstract 2146).
35. Reinoehl J, Frankovich D, Machado C, et al. Probucol-associated tachyarrhythmic events and QT prolongation: Importance of gender. Am Heart J 1996; 131:1184.
36. Lehmann MH, Hardy S, Archibald D, Quart B, MacNeil DJ. Sex difference in risk of torsade de pointes With D,L-Sotalol. Circulation 1996;94:2535.
37. Stramba-Badiale M, Locati EH, Marinelli A, Courville J, Schwartz PJ. Gender and the relationship between ventricular repolarization and cardiac cycle length during 24-h Holter recordings. Eur Heart J 1997;18: 1000.
38. Food and Drug Administration Center for Drug Evaluation and Research. Safety pharmacology studies for assessing the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals. Available from www.fda.gov/cder/guidance /4970dft.htm.
39. Haverkamp W, Eckardt L, Monnig G, et al. Clinical aspects of ventricular arrhythmias associated with QT prolongation. Eur Heart J Supplements 2001;3:K81.
40. The University of Arizona Center for Education and Research on Therapeutics. Drugs that prolong the QT interval and/or induce torsades de pointes ventricular arrhythmia [updated 2004 July 6]. Available from www.azcert.org/medical-pros/drug-lists /drug-lists.htm.
41. Monahan BP, Ferguson CL, Killeavy ES, Lloyd BK, Troy J, Cantilena LR Jr. Torsades de pointes occurring in association with terfenadine use. JAMA 1990;264: 2788.
42. Sanguinetti MC, Jiang C, Curran ME, Keating MT. A mechanistic link between an inherited and an acquired cardiac arrhythmia: HERG encodes the I(kr) potassium channel. Cell 1995;81:299.
43. Zhang S, Zhou Z, Gong Q, Makielski JC, January CT. Mechanism of block and identification of the verapamil binding domain to HERG potassium channels. Circ Res 1999;84:989.
44. Yang T, Snyders D, Roden DM. Drug block of I(kr): Model systems and relevance to human arrhythmias. J Cardiovasc Pharmacol 2001;38:737.
45. Ebert SN, Liu XK, Woosley RL. Female gender as a risk factor for drug-induced cardiac arrhythmias: Evaluation of clinical and experimental evidence. J Wom Health 1998;7:547.
46. Lehmann MH, Hardy S, Archibald D, MacNeil DJ. JTc prolongation with D,L-sotalol in women versus men. Am J Cardiol 1999;83:354.
47. Pham TV, Sosunov EA, Gainullin RZ, Danilo P. Jr, Rosen MR. Impact of sex and gonadal steroids on prolongation of ventricular repolarization and arrhythmias induced by Ik-blocking drugs. Circulation 2001; 103:2207.
48. Houltz B, Darpo B, Edvardsson N, et al. Electrocardiographic and clinical predictors of torsades de pointes induced by almokalant infusion in patients with chronic atrial fibrillation or flutter: A prospective study. Pacing Clin Electrophysiol 1998;21:1044.
49. Napolitano C, Schwartz PJ, Brown AM, et al. Evidence for a cardiac ion channel mutation underlying drug-induced QT prolongation and life-threatening arrhythmias. J Cardiovasc Electrophysiol 2000;11:691.
50. Kay GN, Plumb VJ, Arciniegas JF, Henthorn RW, Waldo AL. Torsades de pointes: The long-short initiating sequence and other clinical features: Observations in 32 patients. J Am Coll Cardiol 1983;2:806.
51. Roden DM, Woosley RL, Primm RK. Incidence and clinical features of the quinidine-associated long QT syndrome: Implications for patient care. Am Heart J 1986;111:1088.
52. Choy AMJ, Darbar D, Dell'Orto S, Roden DM. Exaggerated QT prolongation and cardioversion of atrial fibrillation. J Am Coll Cardiol 1999;34:396.
53. Torp-Pedersen C, Moller M, Bloch-Thomsen PE, et al. Dofetilide in patients with congestive heart failure and left ventricular dysfunction. N Engl J Med 1999; 341:857.
54. Carlsson L, Abrahamsson C, Andersson B, Duker G, Schiller-Linhardt G. Proarrhythmic effects of the class III agent almokalant: Importance of infusion rate, QT dispersion, and early afterdepolarisations. Cardiovasc Res 1993;27:2186.
55. Sesti F, Abbott GW, Wei J, et al. A common polymorphism associated with antibiotic-induced cardiac arrhythmia. Proc Natl Acad Sci USA 2000;97: 10613.
56. Wei J, Yang Ic-H, Tapper AR, et al. KCNE1 polymorphism confers risk of drug-induced long QT syndrome by altering kinetic properties of I(ks)) potassium channels. Circulation 1999;100(Suppl I):I-495 (Abstract).
57. Szarfman A, Machado SG, O'Neill RT. Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the U.S. FDA's Spontaneous Reports Database. Drug Safety 2002;25:381.
58. Krantz MJ, Lewkowiez L, Hays H, Woodroffe MA, Robertson AD, Mehler PS. Torsade de pointes associated with very high-dose methadone. Ann Intern Med 2002;137:501.
59. Martell BA, Arnsten JH, Ray B, Gourevitch MN. The impact of methadone induction on cardiac conduction in opiate users. Ann Intern Med 2003;139:154.