The "black box" warns of known dangers linked to combined use of the products and will appear on labels of more than 400 products.
“We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate ... whether the benefits of using opioids and benzodiazepines ... together outweigh these serious risks.” -- FDA Commissioner Robert Califf, MD.
FDA black box warning states: "Concomitant use of the drugs may result in profound sedation, respiratory depression, coma, and death."
Labeling decision appears based in part on citizens' petition to FDA signed by state, municipal public health officials and other health care professionals. (2)
Citizens' petition states, in part: "...concurrent benzodiazepine use in opioid users is not associated with improved symptoms; instead daily benzodiazepine users have reported higher pain severity and less coping."
Current opioid guidelines: All discourage concomitant therapy with benzodiazepines. Consider non-pharmacologic therapies, ie physical therapy, CBT
No new information offered in petition or boxed warning; physicians have known about these concerns for years.
Long standing problem.Widespread co-prescribing evident 25 years ago; primary reason was as sleep aide; most patients had used them for extended periods.
There is no documented evidence for efficacy of benzodiazepines in treating symptoms associated with chronic pain.
The serotonin-norepinephrine reuptake inhibitors (SNRIs) also have analgesic effect; may bolster opioid analgesia-benzodiazepines do neither.
Neither the citizens’ petition nor FDA warning addresses the well-known fact that benzodiazepines actually interfere with the analgesic effects of opioids.(4)
As part of an ehanced effort to quell rising death rates linked to use of both opioids and benzodiazepines, the FDA requires new class labeling for both groups that warns against prescribing them together. More than 400 products, including opioid-containing cough suppressants, are affected.Pain specialist Steven King, MD, points out that co-prescribing of these drugs is far from a novel practice and has reservations about the ultimate impact of the added guidance.Click through his overview above. And, please, tell us what you're thinking, below.Â Â Â
1. USFDA. Safety Labeling Change Notification. www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM518615.pdf
3. King SA, Strain JJ. Benzodiazepines use by chronic pain patients. Clin J Pain. 1990;6;143-147.
4. Gear RW, Miaskowski C, Heller PH, et al. Benzodiazepine mediated antagonism of opioid analgesia.Pain. 1997;71:25-29.
5. FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use [press release]. Silver Spring: US Food and Drug Administration; September 19, 2016.