.....to include additional information related to the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions associated with this drug class.
Benzodiazepines are widely used to treat a variety of conditions including anxiety disorders, seizure disorders and insomnia.
In a statement, the FDA noted that the “current prescribing information for benzodiazepines does not provide adequate warnings about [the] serious risks and harms associated with these medicines so they may be prescribed and used inappropriately.”
The Boxed Warning update was prompted by the results of an FDA review of postmarketing databases and published literature on the use of benzodiazepines and these associated risks. The review evaluated 104 cases from the FDA Adverse Event Reporting System (FAERS) database from January 1, 1968 through June 30, 2019, which represented a small subset of FAER cases but identified the most descriptive reports of dependence or withdrawal.
About 80% of these cases described benzodiazepine withdrawal, which occurred even when the drug was prescribed for a therapeutic use; most of these cases reported use of the agents for months to years. After starting the benzodiazepine, the time to dependence was reported to range from days to weeks, while withdrawal symptoms were found to last from weeks to years. Abrupt discontinuation, rather than dose tapering, was described in some of these cases and likely led to withdrawal symptoms.
To mitigate the potential for benzodiazepine-related adverse events, the Agency recommends the following:
“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,” said FDA Commissioner Stephen M. Hahn, MD.
“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.”
Source: