Image of FDA Commissioner Stephen M. Hahn, M.D.

The Food and Drug Administration is requiring benzodiazepine drug labels to display its most serious “boxed warning” following growing reports of sedative abuse, the agency announced Thursday. 

All classes of the drug, which include brand names Xanax and Valium, also must carry new prescribing information detailing the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions. Existing patient medication guides must be updated as well, the agency said. 

“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, M.D., said in a statement. The new labeling and guidance information will help healthcare professionals and patients better understand the increased risk, he added.

People who take benzodiazepines for several days to weeks can become physically dependent, the agency warns. Steady use for weeks or months can produce withdrawal symptoms when the medicine is discontinued abruptly or the dose is lowered. Acute withdrawal reactions can include seizures. 

Healthcare providers should help patients develop a plan for tapering off the medications slowly, the FDA advises.