Evaluation of the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets-1960
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Evaluation of the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets-1960 to 1999* Man Fung, Anna Thornton, Kathy Mybeck, Jasmanda Hsiao-hui Wu, Ken Hornbuckle and Edmundo Muniz Drug Information Journal 2001 35: 293 DOI: 10.1177/009286150103500134 The online version of this article can be found at: http://dij.sagepub.com/content/35/1/293
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Drug Information Journal. Vol. 35, pp. 293-317, 2001
0092-8615/2001 Copyright 0 2001 Drug Information Association Inc.
Printed in the USA. All rights reserved.
EVALUATION OF THE CHARACTERISTICS OF SAFETY WITHDRAWAL OF PRESCRIPTION DRUGS FROM WORLDWIDE PHARMACEUTICAL MARKETS-1960 TO 1999* MANFUNG,MD, MBA, FACP Worldwide Pharmacovigilance and Epidemiology, Lilly Research Laboratories, Indianapolis, Indiana, and Eli Lilly Taiwan, Taipei, Taiwan
ANNATHORNTON, FHARMD Worldwide Pharmacovigilance and Epidemiology, Lilly Research Laboratories, Indianapolis, Indiana
KATHYMYBECK,PHARMD Global Medical Information, Lilly Research Laboratories, Indianapolis, Indiana
JASMANDA HSIAO-HUI Wu, MS, MPH Worldwide Pharmacovigilance and Epidemiology, Lilly Research Laboratories, Indianapolis, Indiana
KEN HORNBUCKLE, MPH, DVM, PHD Worldwide Pharmacovigilance and Epidemiology, Lilly Research Laboratories, Indianapolis, Indiana
EDMUNDO MUNIZ,MD, PHD Worldwide Pharmacovigilance and Epidemiology, Lilly Research Laboratories, Indianapolis, Indiana
A descriptive analysis was conducted to evaluate prescription drugs withdrawn from worldwide pharmaceutical markets over the past four decades due to safety reasons.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 identifed, 42.1 % were withdrawnfrom 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 The most common categories of drugs withdrawn were: Non-Steroidal Anti-inflammatory Drugs (13.2%), nonnarcotic analgesics (8.3%),antidepressants (7.4%), and vasodilators (5.8%).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 jive safety reasons for withdrawals were: hepatic (26.2%), hematologic
*An abstract of this paper was presented at the 15th
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