US FDA Requiring Labeling Changes for Benzodiazepines

The U.S. Food and Drug Administration made an announcement during  Drug Safety Communication that the Boxed Warning will require an update and, the agency’s most prominent safety warning, and requiring class-wide labeling changes for benzodiazepines to incorporate the risks of misuse, abuse addiction,  misuse, addiction, physical dependence and withdrawal reactions to ensure safe use.

Benzodiazepines are most used to treat insomnia, panic disorder, seizure, and recommended for use for periods of months or weeks. The dosage, duration, and frequency depend on the patient, the medical condition that the drug is being used, and the duration of the treatment.

Due to misuse and abuse of benzodiazepines together with opioid pain relievers and other medicines, alcohol, and illicit drugs, the FDA is taking measure to ensure new labeling information to 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.

This effort is part of the FDA’s initiative to promote public health by reducing risks associated with inappropriate use of controlled substances while enabling sufficient access to these drugs for medical treatment.
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