Impact of a drug safety communication on the severity of benzonatate exposures reported to poison centers.

Abstract

Identify if publication of the 2010 drug safety communication (DSC) regarding benzonatate was associated with a decrease in the incidence of severe benzonatate poisonings reported to United States poison centers. This retrospective database study utilized the National Poison Data System to compare the incidence of severe benzonatate poisonings before and after the publication of a drug safety communication. We utilized interrupted time series analysis to compare 2000-2010 (pre-DSC) to 2012-2019 (post-DSC). There were 18 619 benzonatate exposures reported to US poison centers during the time period covered and 11 554 exposures were included. There was an increase in exposures throughout the time period. There was no difference in the incidence of severe outcomes in the two time periods. In the pre-DSC era, rates of severe outcomes increased by 0.4% per year followed by an immediate non-significant drop of 2.9% in incidence of severe outcomes (P = .15). Finally, the slope of severe outcomes in the post-DSC era showed an increase of 0.3% per year, which was not significantly different from the pre-DSC era (P = .78). Publication of a Drug Safety Communication regarding the risks of benzonatate did not result in a decrease in the proportion of severe benzonatate poisoning reported to US poison centers. Deaths and other severe outcomes continued to occur at a similar rate after the publication.