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.