We have done a number of posts on the FDA’s activities with regard to assuring the safe use of benzodiazepines (here, here, and here, where we discuss issues regarding increased warnings and potential REMs, and even the specter of abuse-deterrent formulations being applied to benzodiazepines (here)).

While no one knows where this will end up, the FDA keeps taking steps towards what will likely lead to some type of further incremental FDA action.  As the Agency states in its October 28, 2021 notice regarding its views, actions, and continued concern regarding the safe use of these products (here), “[W]hile benzodiazepine prescribing has been trending down since 2016, treatment with benzodiazepines is still widespread; in 2019, an estimated 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient retail and mail-order pharmacies, according to a September 2020 FDA Drug Safety Communication (DSC).”  According to the FDA, “[A]dditionally, every year, almost 5 million people report using benzodiazepines in a manner other than as directed by a physician, with alprazolam being the benzodiazepine most frequently misused.”  The Agency also discusses the fact that many patients use these products for two months or longer, which also raises potential for abuse, addiction, physical dependence, and withdrawal symptoms if patients are not appropriately weaned off of their medication.

Agency research also finds “that abuse, and misuse of benzodiazepines are commonly combined with the use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes.”  The FDA offers a download of the workshop on benzodiazepines held earlier this year with Duke-Margolis Center for Health Policy and presents some additional recommendations provided by the speakers as the Agency continues to march towards better education of practitioners and patients, and (hopefully) continues to improve appropriate prescription and use of these products.  The complete FDA discussion of the workshop can be found here.

We are likely to see more on this topic and, as noted above, additional FDA action to improve and promote the safe use of benzodiazepines.  Stay tuned to see when the next shoe will drop.