Black Box Warning by the United States Food and Drug Administration: The Impact on the Dispensing Rate of Benzodiazepines

Background/objectives: In 9/2020, the United States Food and Drug Administration )FDA( posted a black box warning for all benzodiazepines, addressing their association with serious risks of abuse, addiction, physical dependence, and withdrawal reactions. We evaluated changes in benzodiazepine dispensing rate trends after this warning. Methods: The dataset of Clalit Health Services (Israel’s largest insurer, with 5 million members) was used to identify and collect benzodiazepine dispensing data for all patients who were dispensed these drugs at least once during the study period (1/2017–12/2021). The dispensing rate (number of patients who were dispensed benzodiazepines per month divided by the number of patients alive during that month) was calculated for each month in the study period. Linear regression and change point regression were used to review the change in trend before and after the black box warning. New users of benzodiazepines after the black box warning were analyzed by age. Results: A total of 639,515 patients using benzodiazepines were reviewed. The mean benzodiazepine dispensing rate per month was 0.21 and ranged from 0.17 (in 2/2017) to 0.24 (in 3/2020). No significant change in trend was observed before vs. after the black box warning (slopes of 0.00675 percentage points per month and 0.00001 percentage points per month, respectively; p = 0.38). The change point regression analysis identified a change point in 4/2019, which is prior to the black box warning. New users were younger after the black box warning compared to before this warning. Conclusions: The FDA black box warning did not affect the dispensing rate of benzodiazepines.