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PSYCHOPHARMACOLOGY
FDA Requiring Stronger Warning Label For Benzodiazepines
September 25, 2020   

The US Food and Drug Administration (FDA) has ordered changes to the labeling for benzodiazepines, requiring them to include information on the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions. Benzodiazepines are widely used to treat many conditions, including anxiety, insomnia, and seizures. All benzodiazepine products, which include well-known drugs such as alprazolam, clonazepam, diazepam, and lorazepam (Figure 1), must have warning labels that spell out the risks. In addition to the warning label, the FDA is also requiring changes to prescribing information on all products and existing patient Medication Guides.

Figure.

Reference:

  >> FDA Press Announcement

  >> FDA Drug Safety Communication


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