How many deaths occur annually from adverse drug reactions in the United States?
OBJECTIVE
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.


CONCLUSIONS
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.
Chyka
P A
PA
Department of Pharmacy Practice and Pharmacoeconomics, University of Tennessee, and Southern Poison Center, Memphis, Tennessee, USA.
D016907:Adverse Drug Reaction Reporting Systems; D000367:Age Factors; D002423:Cause of Death; D016009:Chi-Square Distribution; D002965:Classification; D019992:Databases as Topic; D003644:Death Certificates; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006291:Health Policy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009026:Mortality; D004364:Pharmaceutical Preparations / Q000145:classification; D011358:Product Surveillance, Postmarketing; D012449:Safety; D012737:Sex Factors; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations