The US Food and Drug Administration (FDA) has ordered changes to the labeling for benzodiazepines, requiring them to include information on the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions.
The FDA is mandating an update to the Boxed Warning already used for benzodiazepines, along with changes to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections of the prescribing information and revisions to existing patient Medication Guides.
“While benzodiazepines are important therapies for many Americans, they are also commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol and illicit drugs,” FDA Commissioner Stephen M. Hahn, MD, said. “We are taking measures and requiring new labeling information to help health care professionals and patients better understand that while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction and dependence.”
Benzodiazepines are FDA-approved for treatment of indications such as generalized anxiety disorder, insomnia, social phobia, and panic disorder. According to the agency, patients may become physically dependent on benzodiazepines if they take them steadily for several days to weeks. In 2018, the FDA reported, about half of patients prescribed oral benzodiazepines received them for at least 2 months.
“Patients who have been taking a benzodiazepine for weeks or months can have withdrawal signs and symptoms when the medicine is discontinued abruptly or continued in lower doses to avoid withdrawal,” the agency said in a press release. “Stopping benzodiazepines abruptly or reducing the dosage too quickly can result in acute withdrawal reactions, including seizures, which can be life-threatening.”
Researchers this year reported that the rate of benzodiazepine exposures and overdoses among adolescents has grown significantly, and medical outcomes have become more severe. Exposures among youth aged 12 to 18 years increased by 54% from 2000 to 2015, and almost half of all exposures reported in 2015 were categorized as intentional abuse, misuse, or attempted suicide.
In 2019, about 92 million benzodiazepine prescriptions were dispensed from US outpatient pharmacies, with alprazolam (38%), clonazepam (24%), and lorazepam (20%) the most common.