Time to Act on Drug Safety

作者: Thomas J Moore , Bruce M Psaty , Curt D Furberg

DOI: 10.1001/JAMA.279.19.1571

关键词:

摘要: 1While the FDA acted within days of receiving heart valve data, fenfluramine had been approved 24 years earlier. 2 In December 1997, popular nonsedating antihistamine terfenadine was withdrawn because a safer alternative existed without terfenadine’s risk potentially lethal cardiac arrhythmia. 3 Terfenadine on market for 12 years. Discovering new dangers drugs after marketing is common. Overall, 51% have serious adverse effects not detected prior to approval. 4 Merely discovering by itself sufficient protect public. Each year prescription injure 1.5 million people so severely they require hospitalization and 100 000 die, making leading cause death in United States. 5

参考文章(10)
S B Soumerai, J Avorn, S Gortmaker, S Hawley, Effect of government and commercial warnings on reducing prescription misuse: the case of propoxyphene. American Journal of Public Health. ,vol. 77, pp. 1518- 1523 ,(1987) , 10.2105/AJPH.77.12.1518
David A. Kessler, Introducing MEDWatch JAMA. ,vol. 269, pp. 2765- 2768 ,(1993) , 10.1001/JAMA.1993.03500210065033
James A. Reiffel, James R. Cook, Physician attitudes toward the use of type IC antiarrhythmics after the cardiac arrhythmia suppression trial (CAST) American Journal of Cardiology. ,vol. 66, pp. 1262- 1264 ,(1990) , 10.1016/0002-9149(90)91115-M
Tillement Jp, Gauthier F, Albengres E, Current French system of post-marketing drug surveillance. International journal of clinical pharmacology, therapy, and toxicology. ,vol. 28, pp. 312- 314 ,(1990)
Jason Lazarou, Bruce H. Pomeranz, Paul N. Corey, Incidence of Adverse Drug Reactions in Hospitalized Patients: A Meta-analysis of Prospective Studies JAMA. ,vol. 279, pp. 1200- 1205 ,(1998) , 10.1001/JAMA.279.15.1200
Louis K. Hine, B. Burt Gerstman, Robert P. Wise, Yi Tsong, Mortality resulting from blood dyscrasias in the United States, 1984 The American Journal of Medicine. ,vol. 88, pp. 151- 153 ,(1990) , 10.1016/0002-9343(90)90465-P
Hershel Jick, The Discovery of Drug-Induced Illness New England Journal of Medicine. ,vol. 296, pp. 481- 485 ,(1977) , 10.1056/NEJM197703032960904
Brian L Strom, Jeffrey L Carson, Rita Schinnar, Ellen Sim Snyder, Michele Shaw, Descriptive Epidemiology of Agranulocytosis Archives of Internal Medicine. ,vol. 152, pp. 1475- 1480 ,(1992) , 10.1001/ARCHINTE.1992.00400190095018