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FDA: New Boxed Warning on Combining Opioids, Benzodiazepines

      Labeling for prescription opioid pain or cough medicines and benzodiazepines will now carry the strongest available warning regarding serious side effects and death associated with their combined use, according to the Food and Drug Administration.
      The new boxed warnings urge health care professionals to limit prescribing opioid pain medicines with benzodiazepines or other central nervous system depressants only to patients for whom alternative treatment options are inadequate, and to limit dosages and treatment duration to the minimum possible while achieving the desired clinical effect.
      Opioids will include a warning regarding prescribing with benzodiazepines and other central nervous system depressants, including alcohol. Benzodiazepines will include a warning regarding prescribing with opioids.
      The action comes amid ongoing efforts to address an epidemic of opioid addiction across the United States, and in response to a first-of-its-kind “citizen petition” calling for the boxed warnings.
      Sharon Worcester is with the Southeast bureau of Frontline Medical News.

      Editor’s Note

      Most of us should know the potentiation of respiratory depression with concomitant administration of benzodiazepines and opioids. Although the risk of clinically significant respiratory depression with pure opioids (e.g., morphine) has been overblown and is rare in clinical practice, mixing opioids with benzos is known to increase the risk of serious respiratory compromise. The new boxed warning won’t mean we can’t use them together, but we can expect to get the usual communications from our consultant pharmacists when we do. Benzodiazepines —- although most of us still prescribe them at times — are pretty risky and not that effective for many conditions they’re commonly used for, most notably dementia-related agitation. They disinhibit behavior and increase the risk of falls, among other adverse effects. The FDA is taking an appropriate step to remind us not to combine opioids and benzos indiscriminately. As always, let’s keep our individual patients’ situations always at the forefront of decision making.
      —Karl Steinberg, MD, CMD, HMDC
      Editor in Chief