| Am J Med 2000 Aug 1;109(2):122-30 | Related Articles, Links |
Comment in:
How many deaths occur annually from adverse drug reactions
in the United States?
Chyka PA.
Department of Pharmacy Practice and Pharmacoeconomics, University of
Tennessee, and Southern Poison Center, Memphis, Tennessee, USA.
PURPOSE: The numbers of deaths attributed to adverse drug reactions by death
certificates and by the Food and Drug Administration's (FDA) spontaneous
postmarketing surveillance system (MedWatch) were compared in order to
characterize national mortality statistics. METHODS: Mortality statistics
related to adverse drug reactions were obtained from national public-use
databases of death certificates based on appropriate International
Classification of Disease (ICD-9) codes and from MedWatch during 1995. The
number of deaths, frequency distributions of sex and age groups, and rankings
of drug categories associated with adverse reactions were compared.RESULTS:
During 1995, 206 deaths were attributed to adverse drug reactions on death
certificates in the United States, whereas MedWatch tabulated 6,894
fatalities. The proportions of men and women were similar, and the majority of
deaths involved persons 60 years of age and older, in both data sets. The
rankings of drug categories associated with adverse drug reactions differed in
the two data sets.CONCLUSION: The numbers of deaths reported in these data
sets varied 34-fold and were up to several 100-fold less than values based on
extrapolations of surveillance programs. These differences indicate that
better and more comprehensive data are needed to develop appropriate health
care policies to improve drug safety.
PMID: 10967153 [PubMed - indexed for MEDLINE]