The FDA announced in a safety warning today (here) that it was adding a Black Box Warning on all opioid and benzodiazepine products due to continued concern relative to potential fatal interactions and severe adverse events. The warning notes that the “FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths. Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, insomnia, and seizures.”
Firms should expect further communication for the Agency and expect that medication guides will also be revised to describe the new warnings.
