Skip to main content

Advertisement

SpringerLink
Log in

Evaluation of the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets-1960 to 1999

  • Published:
Drug information journal : DIJ / Drug Information Association Aims and scope Submit manuscript

Abstract

A descriptive analysis was conducted to evaluate prescription drugs withdrawn from worldwide pharmaceutical markets over the past four decades due to safety reasons. The list of drugs, including indication, the duration of marketing, and reasons for withdrawal were examined. Among the 121 products identified, 42.1% were withdrawn from European markets alone, 5.0% from North America, 3.3% from Asia Pacific, and 49.6% from markets in multiple continents. Distributions of these withdrawals in each decade were: 12.4% from the 1960s, 16.5% from the 1970s, 39.7% from the 1980s, and 31.4% from the 1990s. Unfortunately, since the denominators (number of drug approvals) were not readily available, an accurate rate of withdrawal could not be reliably calculated. The most common categories of drugs withdrawn were: Non-Steroidal Anti-Inflammatory Drugs (13.2%), nonnarcotic analgesics (8.3%), antidepressants (7.4%), and vasodilators (5.8%). The top five safety reasons for withdrawals were: hepatic (26.2%), hematologic (10.5%), cardiovascular (8.7%), dermatologic (6.3%), and carcinogenic (6.3%) issues. Among the 87 products for which the timing of marketing was available, the median time on the market was 5.4 years with about one-third withdrawn within the first two years. It is hoped that the current review will stimulate other future research into this important topic. However, due to the intrinsic limitations of the descriptive analysis design, our observations are subject to the availability of data in the public domain. Readers are cautioned to be objective and careful when approaching data of this nature in order not to misinterpret the results due to potential data gaps.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Wilford BB, Finch J, Czechowicz DJ, Warren D. An overview of prescription drug misuse and abuse: defining the problem and seeking solutions. J Law Med Ethics. 1994;22:197–203.

    CAS  PubMed  Google Scholar 

  2. Charpak Y, Favre I, Bloch J, Jauffret M, Maire A. Dependence, abuse and misuse of drugs: knowledge and attitudes of private physicians in the Ile-de-France. Rev Epidem el Same Publ. 1999;47:239–247.

    CAS  Google Scholar 

  3. Boyle FM. Adverse interaction of herbal medicine with breast cancer treatment. Med J Australia. 1997; 167:286.

    CAS  PubMed  Google Scholar 

  4. Mann RD. Monitoring the Safety of Medicine. In: Luscombe D, Stonier PD, eds. Clinical Research Manual. Haslemere, England: Euromed Communications; 1994:8.1–8.42.

    Google Scholar 

  5. Flectcher AP. Post-Marketing Surveillance. In, Luscombe D, Stonier PD, eds. Clinical Research Manual. Haslemere, England: Euromed Communications; 1998:15.1–15.26.

    Google Scholar 

  6. Faich GA, Dreis M, Tomita D. National adverse drug reaction surveillance. Arch Int Med. 1998; 148: 785–787.

    Google Scholar 

  7. Anello C. Management of ADR reports at the FDA. Drug Inf J. 1985;19:291–294.

    Google Scholar 

  8. Gordon AJ, Petrick RJ. Worldwide regulations for manufacturers on clinical safety surveillance of drugs. Drug Inf J. 1992;26:1–15.

    Google Scholar 

  9. Griffin JP. Survey of spontaneous adverse drug reaction reporting schemes in fifteen countries. Br J Clin Pharm. 1986;22:83S–100S.

    Google Scholar 

  10. Albengres E. Features of the French postmarketing drug surveillance system. Application to cutaneous effects of nonsteroidal antiinflammatory drugs. J Rheumatol. 1988;15:20–23.

    Google Scholar 

  11. Sachs RM, Bortnichak EA. An evaluation of spontaneous adverse drug reaction monitoring systems. Am J Med. 1986;81:49–55.

    CAS  PubMed  Google Scholar 

  12. Fletcher AP. Spontaneous adverse drug reaction reporting vs. event monitoring: a comparison. J Roy Soc Med. 1991;84:341–344.

    CAS  PubMed  Google Scholar 

  13. Mann RD. Managing adverse reaction information. Drug Inf J. 1992;26:583–587.

    Google Scholar 

  14. Dangoumau J, Lagier G, Royer RJ. A drug information-ADR collection network: the French system. Drug Inf J. 1986;20:337–346.

    CAS  PubMed  Google Scholar 

  15. Talbot JCC. Management of ADR data from different sources. Drug Inf J. 1986;20:297–299.

    Google Scholar 

  16. Koch-Weser J. International aspects of spontaneous reporting of adverse drug reactions. Drug Inf J. 1985;19:217–221.

    Google Scholar 

  17. Rawlins MD. Spontaneous reporting of adverse drug reactions I-II: the data and uses. Br J Clin Pharmacol. 1988;26:1–11.

    CAS  PubMed  PubMed Central  Google Scholar 

  18. Weisberg E. Contraceptive choices—turning back the clock. Adv Contraception. 1991; 7:115–127.

    CAS  Google Scholar 

  19. Welty TE, Privitera M, Shukla R. Increased seizure frequency associated with felbamate withdrawal in adults. Arch Neurol. 1998;55:641–645.

    CAS  PubMed  Google Scholar 

  20. Ashworth L. Is my antihistamine safe? Home Care Provider. 1997;2:117–120.

    CAS  PubMed  Google Scholar 

  21. Bouvier-Colle MH. Drugs: 10 years of recall from the market. Rev Epidem et Sante Publ. 1994;42: 466–467.

    CAS  Google Scholar 

  22. Lynn NJ, Ellis JM. Pharmacists’ liability into the year 2000. J Am Pharm Assoc. 1998;38:747–752.

    CAS  Google Scholar 

  23. Burkhart GA, Sevka MJ, Temple R, Honig PK. Temporal decline in filling prescriptions for terfena-dine closely in time with those for either ketocona-zole or erythromycin. Clin Pharm Therap. 1997; 61:93–96.

    CAS  PubMed  Google Scholar 

  24. Kleinke JD, Gottlieb S. Is the FDA approving drugs too fast? Probably not—but drug recalls have sparked debate. Br Med J. 1998;317:899.

    CAS  Google Scholar 

  25. Miller HI. When is a drug ‘safe’? Nature. 1990; 344:698.

    CAS  PubMed  Google Scholar 

  26. Jefferys DB, Leakey D, Lewis JA, Payne S, Rawlins MD. New active substances authorized in the United Kingdom between 1972 and 1994. Br J Clin Pharmacol. 1998;45:151–156.

    CAS  PubMed  PubMed Central  Google Scholar 

  27. Bakke OM. Drug withdrawals—circumstances and market impact. In: Cato AE, ed. Clinical Drug Trials and Tribulations. New York & Basle: Marcel Dekker Inc.; 1988:377–395.

    Google Scholar 

  28. McGhan WF, Block LH. An analysis of drug recalls and court actions in the United States Pharmaceutical Industry. Pharm Med. 1986;1:187–193.

    Google Scholar 

  29. Anonymous. 1996 product withdrawals in France. SCRIP World Pharmaceutical News. London, UK: PJB Publications Ltd.; July 25, 1997;2252:1.

    Google Scholar 

  30. Anonymous. Rate of drug recalls rises sharply— FDA ‘fast track’ approval called into question. NBC Internet News. June 24, 1999. http://www.msnbc.com/news.

    Google Scholar 

  31. Steward F, Wibberley G. Drug innovation— what’s slowing it down? Nature. 1980;284:118–120.

    CAS  PubMed  Google Scholar 

  32. Goyan JE. The role of evidence in the approval of pharmaceuticals. Ann NY Acad Sci. 1993;703: 275–277.

    CAS  PubMed  Google Scholar 

  33. Weintraub M, Northington FK. Drugs that wouldn’t die. JAMA. 1986;255:2327–2328.

    CAS  PubMed  Google Scholar 

  34. Spriet-Pourra C, Auriche M. Drug Withdrawal from Sale. 2nd Edition. Scrip Reports. Richmond, UK: PJB Publications Ltd.; 1994.

    Google Scholar 

  35. Bakke OM, Wardel WM, Lasagna L. Drug discontinuation in the United Kingdom and Untied States, 1964 to 1983: issues of safety. Clin Pharm Therap. 1984;35:559–567.

    CAS  PubMed  Google Scholar 

  36. Lindstrom LH. The effect of long-term treatment with clozapine in schizophrenia: in 96 patients treated with clozapine for up to 13 years. Acta Psych Scand. 1988;77:524–529.

    CAS  Google Scholar 

  37. Bourgeois BF. Felbamate. Semin Ped Neurol. 1997; 4:3–8.

    CAS  Google Scholar 

  38. Blum DE. New drugs for persons with epilepsy. Adv Neurol. 1998;76:57–87.

    CAS  PubMed  Google Scholar 

  39. Anonymous. BGA wants molsidomine suspension. SCRIP World Pharmaceutical News. London, UK: PJB Publications Ltd.; Oct. 7, 1985; 1040:2.

    Google Scholar 

  40. Lechat P. Problems raised by the withdrawal from the market of drugs in therapeutic use. Therapie. 1987;42:403–410.

    CAS  PubMed  Google Scholar 

  41. Brown MA, McCowan LM, North RA, Walters BN. Withdrawal of nifedipine capsules: jeopardizing the treatment of acute severe hypertension in pregnancy? Australian Society for the Study of Hypertension in Pregnancy. Med J Australia. 1997;166: 640–643.

    CAS  PubMed  Google Scholar 

  42. Anonymous. Prescribe reviews French 1996 launches. SCRIP World Pharmaceutical News. London, UK: PJB Publications Ltd.; Jan. 14, 1997;2197:1.

    Google Scholar 

  43. Hass AE, Portale DB, Grossman RE. New drugs: their market life and safety. Pharm J. 1985;235–238.

    Google Scholar 

  44. Anonymous. Atpidem Suspended in France. SCRIP World Pharmaceutical News. London, UK: PJB Publications Ltd.; 1993;1870:22.

    Google Scholar 

  45. Anonymous. Amineptine: marketing authorization suspended—drug abuse and dependence, France. The WHO Pharmaceuticals Newsletter—Regulatory Actions. Jan. Feb. 1999;1–2. http://www.who.int/dmp/newsletters.

    Google Scholar 

  46. Ekeberg O, Jacobsen D, Flaaten B, Mack A. Effect of regulatory withdrawal of drugs and prescription recommendations on the pattern of self-poisonings in Oslo. Acta Med Scand. 1987;221:483–487.

    CAS  PubMed  Google Scholar 

  47. Anonymous. J&J antihistamine withdrawn. Hismanal taken off shelves. ABC Internet News. June 21, 1999. http://abcnews.go.com/sections/living/DailyNews.

    Google Scholar 

  48. Anonymous. Maker to Discontinue Allergy Drug Hismanal. Washington Post. Online. Jun. 22, 1999. http://washingtonpost.com/wp-srv/healfh.

    Google Scholar 

  49. Anonymous. Hismanal-worldwide withdrawal. Information for Health Professionals. Malaysia Adverse Drug Reaction Advisory Committee Website. July 1999. http://www3.jaring.my/mad.

    Google Scholar 

  50. Anonymous. Astemizole prescription only in UK. SCRIP World Pharmaceutical News. London, UK: PJB Publications Ltd.; July 8, 1998;2350:21.

    Google Scholar 

  51. Bakke OM, Manocchia M, de Abajo F, Kaitin KI, Lasagna L. Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: a regulatory perspective. Clin Pharmacol Then 1995;58:108–117.

    CAS  Google Scholar 

  52. Fenner H. Evaluation of the efficacy and safety of NSAIDs. A new methodological approach. Scand J Rheum. 1989;80(suppl):32–39.

    CAS  Google Scholar 

  53. 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;281:1728–1734.

    CAS  PubMed  Google Scholar 

  54. Williams P, Williams P, Currie WJ, VandenBurg MJ. A double-blind comparison of ‘Osmosin’, be-noxaprofen and placebo in the treatment of osteoarthritis. CurrMedRes Opin. 1983;8(Suppl 2):90–98.

    Google Scholar 

  55. Anonymous. Bromfenac sodium capsules (DURACT®) withdrawn from the market. Dear Doctor Letter. Philadelphia, PA: Wyeth Ayerst Company; 1998.

    Google Scholar 

  56. Anonymous. Bromfenac (DuractR) withdrawn from the market—severe liver failure. The WHO Information Exchange System. Alert No. 71, Jun. 26, 1998. http://www.who.int/dmp/Alerts.

    Google Scholar 

  57. Anonymous. Bromfenac withdrawn—hepatotoxicity, Saudi Arabia. The WHO Pharmaceuticals Newsletter—Regulatory Actions. May & June 1999;5&6. http://www.who.int/dmp/newsletters.

    Google Scholar 

  58. Anonymous. EC chlormezanone withdrawal confirmed. SCRIP World Pharmaceutical News. London, UK: PJB Publications Ltd.; Oct. 10, 1997;2276:5.

    Google Scholar 

  59. Anonymous. Chlormezanone withdrawn because of cutaneous toxicity—update. The WHO Pharmaceuticals Newsletter—Regulatory Actions. Jan. & Feb. 1997; 1&2. http://www.who.int/dmp/newsletters.

    Google Scholar 

  60. Anonymous. Chlormezanone marketing authorization withdrawn, Germany. The WHO Pharmaceuticals Newsletter—Regulatory Actions. Nov. & Dec. 1997;11&12. http://www.who.int/dmp/newsletters.

    Google Scholar 

  61. Anonymous. Chlormezanone withdrawn, United Arab Emirates. The WHO Pharmaceuticals News-letter—Regulatory Actions. Mar. & Apr. 1998;3& 4. http://www.who.int/dmp/newsletters.

    Google Scholar 

  62. Anonymous. Chlormezanone withdrawn, Zim-babwe. The WHO Pharmaceuticals Newsletter—Regulatory Actions. Sept. & Oct. 1998;9&10. http://www.who.int/dmp/newsletters.

    Google Scholar 

  63. Anonymous. Chlormezanone withdrawn, Saudi Arabia. The WHO Pharmaceuticals Newsletter—Regulatory Actions. May & Jun. 1999;5&6. http://www.who.int/dmp/newsletters.

    Google Scholar 

  64. Anonymous. Cardiac valvulopafhy associated with exposure to fenfluramine or dexfenfluramine: U.S. Department of Health and Human Services interim public health recommendations, Nov. 1997. MMWR. 1997;46:1061–1066.

    Google Scholar 

  65. Anonymous. Warning not to use products containing fenfluramine (Ponderal, Ponderax) or dexfenfluramine (Redux). Health Canada Web site. Sept. 15, 1997. http://www.hc-sc.gc.ca.

    Google Scholar 

  66. Anonymous. Withdrawal of fenfluramine (Ponderax) and dexfenfluramine (Adifax). The Medicines Control Agency Web site, http://www.open.gov.uk/mca.

  67. Anonymous. Fenfluramine and dexfenfluramine. The European Agency for the Evaluation of Medicinal Products Press Release. The EMEA Web site. Sept. 9, 1999. http://www.eudra.org/emea.html.

    Google Scholar 

  68. Anonymous. Fenfluramine and dexfenfluramine. Information for Health Professionals. Malaysia Adverse Drug Reaction Advisory Committee Web site. http://www3.jaring.my/mad.

  69. Anonymous. Fenfluramine and dexfenfluramine withdrawn—cardiotoxicity (USA). The WHO Information Exchange System. Alert No. 63, Sept. 16, 1997. http://www.who.int/dmp/Alerts.

    Google Scholar 

  70. Anonymous. Fenfluramine and dexfenfluramine withdrawn, India. The WHO Pharmaceuticals Newsletter—Regulatory Actions. May & Jun. 1998; 5&6. http://www.who.int/dmp/newsletters.

    Google Scholar 

  71. Anonymous. Fenfluramine and dexfenfluramine: withdrawn: Saudi Arabia. The WHO Pharmaceuticals Newsletter—Regulatory Actions. May & Jun. 1999;5&6. http://www.who.int/dmp/newsletters.

    Google Scholar 

  72. Anonymous. Diet drugs pulled off the market. The Wall Street Journal Internet News. Sept. 15, 1997. http://interactive.wsj.com/dailyedition.

    Google Scholar 

  73. Anonymous. Withdrawal of oxyphenisatin acetate, diacetoxydiphenolisatin and triacetyldiphenolisatin from the Australian market. Med J Australia. 1972; 1:1051–1053.

    Google Scholar 

  74. Mihajlovic G. Recall of metamizole from the market in countries with modern pharmacotherapy. Srpski Arhiv Za Celokupno Lekarstvo. 1996;124: 44–46.

    CAS  PubMed  Google Scholar 

  75. Anonymous. Metamizole sodium—prohibited, Nepal. The WHO Pharmaceuticals Newsletter—Regulatory Actions. Nov. & Dec. 1997;11&12. http://www.who.int/dmp/newsletters.

    Google Scholar 

  76. Anonymous. Metamizole sodium—withdrawn due to agranulocytosis, Zimbabwe. The WHO Pharmaceuticals Newsletter—Regulatory Actions. Sept. & Oct. 1998;9&10. http://www.who.int/dmp/newsletters.

    Google Scholar 

  77. Anonymous. Metamizole sodium—withdrawn due to agranulocytosis, Yemen. The WHO Pharmaceuticals Newsletter—Regulatory Actions. Jan. & Feb. 1999; 1 &2. http://www.who.int/dmp/newsletters.

    Google Scholar 

  78. Anonymous. Metamizole sodium—marketing authorization suspended, Sweden. The WHO Pharma-ceuticals Newsletter—Regulatory Actions. May & Jun. 1999;5&6. http://www.who.int/dmp/newsletters.

    Google Scholar 

  79. Anonymous. Withdrawal of medicinal products containing ebrotidine—liver toxicity. The WHO Information Exchange System. Alert No. 72, Jul. 29, 1998. http://www.who.int/dmp/Alerts.

    Google Scholar 

  80. Anonymous. Bristol-Myers Squibb (BMS) Enkaid withdrawn in US. SCRIP World Pharmaceutical News. London, UK: PJB Publications Ltd.; Sep. 25, 1991;1654:20.

    Google Scholar 

  81. Anonymous. Fenfluramine—withdrawn. The WHO Pharmaceuticals Newsletter—Regulatory Actions. Mar. & Apr. 1998;3&4. http://www.who.int/dmp/newsletters.

    Google Scholar 

  82. Beasley R, Pearce N, Crane J, Burgess C. With-drawal of fenoterol and the end of the New Zealand asthma mortality epidemic. IntArch Allerg Immun. 1995;107:325–327.

    CAS  Google Scholar 

  83. Crane J, Pearce N, Flatt A, et al. Prescribed fenoterol and death from asthma in New Zealand, 1981 — 83: case-control study. Lancet. 1989;1:917–922.

    CAS  PubMed  Google Scholar 

  84. Anonymous. Glaxo pulls antibiotic on safety fears. Reuters Internet News. Oct. 27, 1999. http://www.reuters.com/news.

    Google Scholar 

  85. Henry JA, Martin AJ. The risk-benefit assessment of antidepressant drugs. Med Toxic Ad Drug Experience. 1987;2:445–462.

    CAS  Google Scholar 

  86. Anonymous. Ketorolac withdrawn in France. SCRIP World Pharmaceutical News. London, UK: PJB Publications Ltd.: Jan. 7th/l 1th, 1994;1886/87: 27.

    Google Scholar 

  87. Anonymous. Ketorolac post marketing surveillance (PMS) study published. SCRIP World Pharmaceutical News. London, UK: PJB Publications Ltd.; Feb. 16, 1996;2103:1.

    Google Scholar 

  88. Anonymous. Ketorolac—extension of suspension. The WHO Pharmaceuticals Newsletter—Regulatory Actions. Jan. & Feb. 1997;1&2. http://www.who.int/dmp/newsletters.

    Google Scholar 

  89. Garcia C. Mianserin agranulocytosis followed by oxitriptan eosinophilia. Nervenarzt. 1992;63:303–307.

    CAS  PubMed  Google Scholar 

  90. Anonymous. Posicor. Irish Medicines Board Press Release. June 8. 1998. http://www.imb.ie/news.

    Google Scholar 

  91. Anonymous. Mibefradil (Posicor). Information for Health Professionals. Malaysia Adverse Drug Reaction Advisory Committee Web site. http://www3.jaring.my/mad.

  92. Anonymous. Mibefradil (Posicor)—withdrawn from the market: potential harmful interactions. The WHO Information Exchange System. Alert No. 70, Jun. 15, 1998. http://www.who.int/dmp/Alerts.

    Google Scholar 

  93. Anonymous. Roche withdraws hypertension drug from the market. The Wall Street Journal Internet News. Jun. 8, 1998. http://interactive.wsj.com/dailyedition

    Google Scholar 

  94. Anonymous. Mebefradil—suspended, Germany. The WHO Pharmaceuticals Newsletter—Regulatory Actions. Sept. & Oct. 1998;9&10. http://www.who.int/dmp/newsletters.

    Google Scholar 

  95. Anonymous. Muzolimine withdrawn in Europe. SCRIP World Pharmaceutical News. London, UK: PJB Publications Ltd.; Jul. 17, 1987;1223:22.

    Google Scholar 

  96. Anonymous. Ciba-Geigy implements Coramine withdrawal. SCRIP World Pharmaceutical News. London, UK: PJB Publications Ltd.; Oct. 4, 1989; 1452:11.

    Google Scholar 

  97. Anonymous. CSM Update. Withdrawal of Nomifensine. Br Med J. 1986;293:41.

    Google Scholar 

  98. Martlew VJ. Immune haemolytic anemia and nomifensine treatment in north west England 1984-85: report of six cases. J Clin Path. 1986;39:1147–1150.

    CAS  PubMed  Google Scholar 

  99. Delchier JC, Metreau JM, Levy VG, Opolon P, Dhumeaux D. Oxyphenisatin, a laxative responsible for chronic hepatitis and cirrhosis, still marketed in France. Nouvelle Presse Medicate. 1979;8:2955–2958.

    CAS  Google Scholar 

  100. Anonymous. Liver complications result in withdrawal of attention deficit hyperactivity disorder drug cylert. Health Canada Web site. Sept. 22, 1999. http://www.hc-sc.gc.ca.

    Google Scholar 

  101. Anonymous. Volital (pemoline) has been with-drawn. The Medicines Control Agency Web site. http://www.open.gov.uk/mca.

  102. Anonymous. Pemoline withdrawn—hepatotoxicity, UK. The WHO Pharmaceuticals Newsletter—Regulatory Actions. Nov. &Dec. 1997;11&12. http://www.who.int/dmp/newsletters.

    Google Scholar 

  103. Brunner FP, Selwood NH. End-stage renal failure due to analgesic nephropathy, its changing pattern and cardiovascular mortality. EDTA-ERA Registry Committee. Nephrol Dial Transplant. 1994;9: 1371–1376.

    CAS  PubMed  Google Scholar 

  104. Pommer W, Glaeske G, Molzahn M. The analgesic problem in the Federal Republic of Germany: analgesic consumption, frequency of analgesic nephropathy and regional differences. Clin Nephrol. 1986; 26:273–278.

    CAS  PubMed  Google Scholar 

  105. McGuinness ME, Talbert RL. Phenformin-induced lactic acidosis: a forgotten adverse drug reaction. Ann Pharmaco. 1993;27:1183–1187.

    CAS  Google Scholar 

  106. Anonymous. Malaysia withdraws prenylamine registrations. SCRIP World Pharmaceutical News. London, UK: PJB Publications Ltd.; Nov. 9, 1988; 1359:19.

    Google Scholar 

  107. Anonymous. Proxibarbal: voluntary withdrawal. The WHO Pharmaceuticals Newsletter—Regulatory Actions. May & Jun. 1998;5&6. http://www.who.int/dmp/newsletters.

    Google Scholar 

  108. Anonymous. UK suspends Lundbeck’s antipsychotic treatment. Health News Daily. Dec. 7, 1998. http://www.medicalnetinc.com/reuters.

    Google Scholar 

  109. Anonymous. Notification of suspension of Serdolect (sertindole). Irish Medicines Board. Dear Doctor Letter. Nov. 23, 1998. http://www.imb.ie/news.

    Google Scholar 

  110. Anonymous. Suspension of availability of sertindole. The Medicines Control Agency Web site. http://www.open.gov.uk/mca.

  111. Anonymous. Sertindole (Serdolect) suspended—cardiac arrhythmias and sudden cardiac death. The WHO Information Exchange System. Alert No. 78, Dec. 4, 1998. http://www.who.int/dmp/Alerts.

    Google Scholar 

  112. Anonymous. Sorivudine & nevirapine on FDA panel. SCRIP World Pharmaceutical News. London, UK: PJB Publications Ltd.; May 21, 1996; 2130:1.

    Google Scholar 

  113. Davey P, McDonald T. Postmarketing surveillance of quinolones, 1990 to 1992. Drugs. 1993;45 (Suppl 3):46–53.

    PubMed  Google Scholar 

  114. Anonymous. Temafloxacin-anatomy of a with-drawal. SCRIP World Pharmaceutical News. London, UK: PJB Publications Ltd.; 1992;1737:20–21.

    Google Scholar 

  115. Anonymous. Hoechst Marion Roussel (HMR) withdraws Seldane in US. SCRIP World Pharmaceutical News. London, UK: PJB Publications Ltd.; Feb. 1998;2298:1.

    Google Scholar 

  116. Anonymous. Terfenadine suspension & restricted use. The WHO Pharmaceuticals Newsletter—Regulatory Actions. Mar. &Apr. 1997;3&4. http://www.who.int/dmp/newsletters.

    Google Scholar 

  117. Anonymous. Terfenadine prohibited. The WHO Pharmaceuticals Newsletter—Regulatory Actions. May & Jun. 1998;5&6. http://www.who.int/dmp/newsletters.

    Google Scholar 

  118. Anonymous. Terfenadine withdrawn—cardiotoxicity, Saudi Arabia. The WHO Pharmaceuticals Newsletter—Regulatory Actions. May & Jun. 1999; 5&6. http://www.who.int/dmp/newsletters.

    Google Scholar 

  119. van der Klauw MM, van Rey FJ, Strieker BH. Polymorph ventricular tachycardia with torsades de pointes caused by administration of terodiline (Mictrol). Nederlands Tijdschrift voor Geneeskunde. 1992;136:91–93.

    PubMed  Google Scholar 

  120. Edwards RI, Lindquist M, Wiholm BE, Napke E. Quality criteria for early signals of possible adverse drug reactions. Lancet. 1990;336:156–158.

    CAS  PubMed  Google Scholar 

  121. Haberle DA, Davis JM, Kawabata M, Metz C, Wapler P, Stachl M. Renal and single-nephron function is comparable in thiobutabarbitone- and thio-pentone-anaesthetised rats. Pflugers Archive—Eur J Physiol. 1993;424:224–230.

    CAS  Google Scholar 

  122. Barclay WR. Ticrynafen’s withdrawal from the market. JAMA. 1980;243:771.

    CAS  PubMed  Google Scholar 

  123. Finkle MJ. Anatomy of drug withdrawals in the United States. In: Cato AE, ed. Clinical Drug Trials and Tribulations. New York & Basle: Marcel Dekker Inc.; 1988:363–375.

    Google Scholar 

  124. Marcus CJ, Griffin JP. New chemical entities 1972-1982: licensing and subsequent adverse reactions. A UK/US comparison. Pharm Int. 1984;5:146–149.

    Google Scholar 

  125. Anonymous. Liver complications reported with anti-Parkinson’s drug Tasmar. Health Canada Web site. Nov. 23, 1998. http://www.hc-sc.gc.ca.

    Google Scholar 

  126. Anonymous. Notification of withdrawal of Tasmar. Irish Medicines Board. Dear Doctor Letter. Nov. 23, 1998. http://www.imb.ie/news.

    Google Scholar 

  127. Anonymous. Withdrawal of Tasmar (tolcapone) from the market. The Medicines Control Agency Website, http://www.open.gov.uk/mca.

  128. Anonymous. Recommendation for the suspension of the marketing authorization for Tasmar. The European Agency for the Evaluation of Medicinal Products Press Release. The EMEA Web site. Nov. 17, 1998. http://www.eudra.org/emea.html.

    Google Scholar 

  129. Anonymous. Tolcapone (Tamar)—liver failure: suspension & warnings. The WHO Information Exchange System. Alert No. 75, Nov. 21, 1998. http://www.who.int/dmp/Alerts.

    Google Scholar 

  130. Anonymous. Tolcapone withdrawn—hepatotoxicity, Australia. The WHO Pharmaceuticals Newsletter—Regulatory Actions. May & Jun. 1999;5&6. http://www.who.int/dmp/newsletters.

    Google Scholar 

  131. Anonymous. Tolrestat withdrawn—hepatic necrosis. The WHO Pharmaceuticals Newsletter—Regulatory Actions. Mar. &Apr. 1997;3&4. http://www.who.int/dmp/newsletters.

    Google Scholar 

  132. Meyboom RH. The Halcion affair in 1979, a false alarm? Nederlands Tijdschrift voor Geneeskunde. 1989;133:2185–2190.

    CAS  PubMed  Google Scholar 

  133. Meyboom RH. Secondary effects of drugs. The 1979 Halcion experience in the Netherlands, a false alarm? Therapie. 1991;46:373–377.

    CAS  PubMed  Google Scholar 

  134. Nazareth I, Ashworth M, Hammond J, King M. Withdrawal of triazolam’s product licence: effect on patients 18 months later. Addiction. 1995;90: 927–934.

    CAS  PubMed  Google Scholar 

  135. Brahams D. Medicine and the law. Triazolam suspended. Lancet. 1991;338:938.

    CAS  PubMed  Google Scholar 

  136. Anonymous. Trovafloxacin & alatrofloxacin—suspension and warnings: hepatotoxicity. The WHO Information Exchange System. Alert No. 86, Jun. 18, 1999. http://www.who.int/dmp/Alerts.

    Google Scholar 

  137. Anonymous. Trovafloxacin & alatrofloxacin—suspension and warnings. Information for Health Professionals. Malaysia Adverse Drug Reaction Advisory Committee Web site. July 1999. http://www3.jaring.my/madrac.

    Google Scholar 

  138. Anonymous. Diabetes drug spurs worries about safety. The Wall Street Journal Internet News. Dec. 1, 1997. http://interactive.wsj.com/dailyedition.

    Google Scholar 

  139. Anonymous. Troglitazone (Romozin) withdrawn. The Medicines Control Agency Website, http://www.open.gov.uk/mca.

  140. Goyan JE. Withdrawal of a drug from the market. What should the prescriber do? JAMA. 1993; 270: 1976–1977.

    CAS  PubMed  Google Scholar 

  141. Levy DB, Vasilomanolakis EC. Anaphylactic reaction due to zomepirac. Drug Intel Clin Pharm. 1984;18:983–984.

    CAS  Google Scholar 

  142. Speirs CJ. Comparison of the safety of several nonsteroidal anti-inflammatory drugs currently or formerly marketed in the United Kingdom. J Clin Pharmacol. 1988;28:S8–S12.

    CAS  PubMed  Google Scholar 

  143. Patton WN, Duffull SB. Idiosyncratic drug-induced haematological abnormalities. Incidence, pathogenesis, management and avoidance. Drug Safety. 1994;11:445–462.

    CAS  PubMed  Google Scholar 

  144. Heimpel H. When should the clinician suspect a drug-induced blood dyscrasia, and how should he proceed? Eur J Haematol. 1996;60 (supl):11–15.

    CAS  Google Scholar 

  145. Knapp DE, Robinson JI, Britt AL. Annual adverse drug experience report: 1995. The FDA Website. http://www.fda.gov/cder/aers/index.htm.

    Google Scholar 

  146. Touw DJ. Clinical implications of genetic polymorphisms and drug interactions mediated by cytochrome P-450 enzymes. Drug Met Drug Int. 1997; 14:55–82.

    CAS  Google Scholar 

  147. Jefferson JW. Drug and diet interactions: avoiding therapeutic paralysis. J Clin Psych. 1998;59(Suppl 16):31–39.

    CAS  Google Scholar 

  148. Stirling D, Sherman M, Strauss S. Thalidomide: A surprising recovery. J Am Pharm Assoc. 1997;37: 306–313.

    Google Scholar 

  149. Schuler U, Ehninger G. Thalidomide: rationale for renewed use in immunological disorders. Drug Safety. 1995;12:364–369.

    CAS  PubMed  Google Scholar 

  150. Tseng S, Pak G, Washenik K, Pomeranz MK, Shu-pack JL. Rediscovering thalidomide: a review of its mechanism of action, side effects, and potential uses. J Am Acad Derm. 1996;35:969–979.

    CAS  PubMed  Google Scholar 

  151. Koren G, Pastuszak A. How to ensure fetal safety when mothers use isotretinoin (Accutane). Can Fam Phy. 1997:43:216–219.

    CAS  Google Scholar 

  152. Montero D, Moore N, Coulson R, et al. Electronic transmission of rapid alerts in pharmacovigilance: a pilot EC experiment. Pharmacoepi Drug Safety. 1994;3:163–167.

    Google Scholar 

  153. Kessler DA, Hass AE, Feiden KL, Lumpkin M, Temple R. Approval of new drugs in the United States. Comparison with the United Kingdom, Germany, and Japan. JAMA. 1996;276:1826–1831.

    CAS  PubMed  Google Scholar 

  154. Weber JCP. Limitations of a voluntary reporting system. In: Hawkins DF, ed. Drugs and Pregnancy; Human Teratogenesis and Related Problems. Edinburgh: Churchill Livingstone; 1983:31–40.

    Google Scholar 

  155. Clark JA, Klincewicz SL, Turner ME, Arellano FM. Spontaneous reporting sequences and the Weber effect: a new look at an old phenomenon. Phar-macoepidem Drug Safety. 1999;8:S95.

    Google Scholar 

  156. Fung M, Kwong K, Mockbee C, Hornbuckle K, Muniz E. Analysis of the occurrence of Weber effect in spontaneous adverse event reporting. Pharmacoepidem Drug Safety. 1999;8:S106.

    Google Scholar 

  157. Coppinger PL, Peck CC, Temple RJ. Understanding comparisons of drug introductions between the United States and the United Kingdom. Clin Pharmacol Ther. 1989;46:139–145.

    CAS  PubMed  Google Scholar 

  158. Hayes AH Jr. Safety considerations in product development. Drug Safety. 1990;5(Suppl 1):24–26.

    PubMed  Google Scholar 

  159. Anonymous. FDA panel recommends continued use of controversial diabetes drug. CNN Interactive News. Mar. 26, 1999. http://cnn.com/HEALTH.

    Google Scholar 

  160. Anonymous. FDA places stricter controls on diabetes drug. CAW Interactive News. June 17, 1999. http://cnn.com/HEALTH.

    Google Scholar 

  161. Anonymous. New concerns about side effects of AIDS—fighting protease inhibitors. CNN Interactive News. June 30,1998. http://cnn.com/HEALTH.

    Google Scholar 

  162. Anonymous. HIV protease inhibitors—hyperglycemia. The WHO Pharmaceuticals Newsletter—Regulatory Actions. Nov. & Dec. 1997;11&12. http://www.who.int/dmp/newsletters.

    Google Scholar 

  163. Anonymous. HIV protease inhibitors revised data sheet-increased blood sugar. The WHO Pharmaceuticals Newsletter—Regulatory Actions. July & Aug. 1998;7&8. http://www.who.int/dmp/newsletters.

    Google Scholar 

  164. Anonymous. HIV protease inhibitors: lipodystrophy, hyperglycaemia, and nephrolithiasis. The WHO Pharmaceuticals Newsletter—Drug Surveillance. July & Aug. 1998;7&8. http://www.who.int/dmp/newsletters.

    Google Scholar 

  165. Ross-Degnan D, Soumerai SB, Fortess EE, Gurwitz JH. Examining product risk in context. Market withdrawal of zomepirac as a case study. JAMA. 1993;270:1937–1942.

    CAS  PubMed  Google Scholar 

Download references

Author information

Author notes

  1. Man Fung MD, MBA, FACP

    Present address: Worldwide Pharmacovigilance and Epidemiology, DC-1778, Lilly Research Laboratories, Indianapolis, Indiana, 46285, USA

Authors and Affiliations

  1. Worldwide Pharmacovigilance and Epidemiology, DC-1778, Lilly Research Laboratories, Indianapolis, Indiana, 46285, USA

    Anna Thornton PharmD, Jasmanda Hsiao-Hui Wu MS, MPH, Ken Hornbuckle MPH, DVM, PHD & Edmundo Muniz MD, PHD

  2. Eli Lilly Taiwan, Taipei, Taiwan

    Man Fung MD, MBA, FACP

  3. Global Medical Information, Lilly Research Laboratories, Indianapolis, Indiana, USA

    Kathy Mybeck PharmD

Authors
  1. Man Fung MD, MBA, FACP
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Anna Thornton PharmD
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Kathy Mybeck PharmD
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Jasmanda Hsiao-Hui Wu MS, MPH
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Ken Hornbuckle MPH, DVM, PHD
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Edmundo Muniz MD, PHD
    View author publications

    You can also search for this author in PubMed Google Scholar

Additional information

An abstract of this paper was presented at the 15th International Conference on PharmacoEpidemiology, August 26–29, 1999, Boston, Massachusetts.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Fung, M., Thornton, A., Mybeck, K. et al. Evaluation of the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets-1960 to 1999. Ther Innov Regul Sci 35, 293–317 (2001). https://doi.org/10.1177/009286150103500134

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1177/009286150103500134

Key Words

Search

Navigation