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

Abstract

Purpose 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. Methods 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). Results 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). Conclusion 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.

Trend changes of national zolpidem users and exposure cases after FDA drug safety communications

“…In this situation, NPDS may be more sensitive than claims data for looking at clinical outcomes of interest. Because specially trained CSPIs code each case with a product-specific substance code and capture detailed exposure information whenever possible, 11,24 specific dose categories for each drug were available. NPDS also captures drug exposures resulting from a family member's prescription.…”

“…Few studies reported the dosage information using the NPDS data. 24,25 Some drugs/products may have had a higher missing rate of dose information than other products. Another limitation is using national drug utilization as denominators for children, assuming who experience side effects that in NPDS are the patients for whom the medication was prescribed.…”

A description of the clinical course of severe benzonatate poisonings reported in the literature and to NPDS: A systematic review supplemented with NPDS cases

“…Although we included all fatalities, we did not include any "major" outcome cases as the limited information from just the coded data may not be as useful and studies utilizing coded data have already been performed. 2,24 This exclusion of major or moderate cases biases the outcomes toward fatality. There is a risk of duplicating cases from the published literature and the NPDS fatality module.…”

“…1 Calls to poison centers about benzonatate exposures have risen drastically (doubling since the 2012 FDA warning) with a concomitant increase in the number of severe poisonings from approximately 120 in 2012 to 240 in 2019. 2 Sporadic cases of severe benzonatate poisoning are reported in the literature. [3][4][5] This was a descriptive study using the National Poison Data System (NPDS) fatalities module in combination with a systematic review to describe the S40 Human and Experimental Toxicology 40(12S) course of severe poisoning and deaths from benzonatate.…”

“…1 Calls to poison centers about benzonatate exposures have risen drastically (doubling since the 2012 FDA warning) with a concomitant increase in the number of severe poisonings from approximately 120 in 2012 to 240 in 2019. 2 Sporadic cases of severe benzonatate poisoning are reported in the literature. 3–5…”