Benzodiazepines will be required to have class-wide labeling changes to include warnings about risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions, the FDA announced Wednesday.
The updates will be made to the boxed warning benzodiazepines already carry that cautions about risks associated with using the drugs concurrently with certain opioids.
"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 Hahn, MD, said in a statement. "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."
About 92 million benzodiazepine prescriptions were dispensed from U.S. outpatient pharmacies in 2019, most commonly alprazolam (Xanax) at 38%, clonazepam (Klonopin) at 24%, and lorazepam (Ativan) at 20%, the FDA reported. In 2018, an estimated 50% of patients who had oral benzodiazepines dispensed received them for 2 months or longer.
The drugs are approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder, and are used as premedication before some medical procedures. Dose, frequency, and treatment depend on the patient, the indication, and the specific drug being prescribed, but "most benzodiazepines are recommended for use for periods of weeks or months," the agency wrote.
Physical dependence can occur when benzodiazepines are taken steadily for several days to weeks, the FDA said. Patients using benzodiazepines for weeks or months can have withdrawal symptoms if the drugs are discontinued abruptly or continued in lower doses.
"Stopping benzodiazepines abruptly or reducing the dosage too quickly can result in acute withdrawal reactions, including seizures, which can be life-threatening," the agency warned. "Prior to stopping benzodiazepines, patients should talk to their healthcare provider to develop a plan for slowly tapering the medication."
In addition to the boxed warning update, the FDA is requiring other changes to the warnings and precautions, drug abuse and dependence, and patient counseling information sections of prescribing information for all benzodiazepine products.
The agency is also requiring revisions to existing patient medication guides for these drugs.
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