FDA continues to focus on the safe use of benzodiazepines. One critical element of increasing our understanding of their benefits and risks is through collaborations and stakeholder outreach. One of the agency’s initiatives on this important topic was to host a workshop earlier this year with Duke-Margolis Center for Health Policy.
Benzodiazepines are a class of drugs that work to produce drowsiness or a calming effect and are widely used to treat many conditions, including anxiety, insomnia, seizures, social phobia, and panic disorder. Benzodiazepines are also used as premedication before some medical procedures. However, it is important for prescribers to consider the risks of benzodiazepine misuse, abuse, addiction, and physical dependence, and monitor patients on therapy, even when patients take the medication as prescribed.
While 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 pharm_acies, according to a September 2020 FDA Drug Safety Communication (DSC). Further, this DSC noted that patients are often treated for a long time; in 2018, around half of patients who were dispensed oral benzodiazepines received them for two months or longer. This long time period is noteworthy because patients can experience withdrawal symptoms after discontinuation or dose reduction even when the benzodiazepine was prescribed for therapeutic use. Additionally, 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.
FDA’s Actions to Help Ensure Safe Use of Benzodiazepines
FDA is aware of the risks of benzodiazepine misuse, abuse, addiction, physical dependence, and withdrawal, and has taken a multifaceted approach to ensure people use these medications safely. For one, the agency has been monitoring safety concerns related to benzodiazepines through analysis of postmarketing safety data, adverse event reports, and the published literature. Our analyses found 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. Our findings also supported the known risk of serious withdrawal reactions after people suddenly stop the medication or reduce their dosage too quickly, in some cases lasting for many months. Review of FDA Adverse Event Reporting System reports revealed that some health care providers and patients explicitly requested stronger warnings and better education about the risk of benzodiazepine dependence and withdrawal, even at typical therapeutic doses and with short periods of use.
We have also taken regulatory action. In the September 2020 DSC, FDA announced it would require an update to the Boxed Warning, which includes information on a prescription drug’s label designed to call attention to serious or life-threatening risks, for all benzodiazepines to address the serious risks of misuse, abuse, addiction, physical dependence, and withdrawal reactions, along with the need for a gradual taper when discontinuing or reducing the dose.
Outside of monitoring and regulatory activities, FDA works to raise awareness of risks associated with benzodiazepines through scientific meetings, public-private partnerships, and funded research, as well as engaging with clinicians, patients, and other stakeholders to gather on-the-ground perspectives on medication use. As an example, we’ve spoken with prescribers to better understand prescribing practices and real-world use. Through these conversations, we heard their experiences prescribing, tapering, and discontinuing benzodiazepines, and we learned that some clinicians were either unaware or had limited recall of FDA’s most recent benzodiazepine safety labeling change.
Information Sharing Through Scientific Meetings
To continue to explore benzodiazepine safety, FDA and Duke-Margolis hosted a two-day virtual workshopExternal Link Disclaimer this past summer that brought together regulators, academic researchers, cl...
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