FDA requires benzodiazepine labels to include addiction risks
The FDA announced that manufacturers of benzodiazepines will be required to update their boxed warning to list the risks for abuse, addiction, misuse, physical dependence and withdrawal reactions associated with the drugs.
“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 in a press release.
Benzodiazepines are an important treatment for patients with generalized anxiety disorder, insomnia, seizures, social phobia and panic disorders, and are also a premedication for certain medical procedures, the agency noted.
According to the FDA, approximately 92 million prescriptions for benzodiazepines were dispensed in 2019. In 2018, 50% of patients who were prescribed oral benzodiazepines took them for 2 months or longer; most benzodiazepines are only recommended to use for a period of weeks or months.
The FDA noted that taking these drugs steadily over multiple days or weeks can lead to physical dependence, and those who take them for longer periods of weeks or months can experience signs and symptoms of withdrawal when the medications are abruptly discontinued or the patients are switched to a lower dose. The FDA added that stopping these medications or reducing dosages too quickly can cause acute withdrawal reactions, including seizures.
The agency said patients should talk to their health care providers before stopping benzodiazepines to develop a plan to taper the medication.
In addition to the boxed warning, the FDA is requiring changes to prescribing information on all benzodiazepine products in the warning and precautions, drug abuse and dependence, and patient counseling information sections, along with revisions to existing patient medication guides.
“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,” Hahn said.