FDA warns against combining opioids, benzodiazepines

Labeling for prescription opioid pain or cough medicine 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.

“First, the FDA is requiring companies to update their product labeling for ... benzodiazepines and opioids to include possible harms when they are used together. Second, we are requiring new or updates medication guides for these drugs reflecting those same warnings,” said the deputy director of FDA’s Center for Drug Evaluation and Research.

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.

In addition, the FDA has issued a safety communication to warn the public about the serious risk of taking these products together to help make doctors more cautious and patients better informed.

The action comes amid ongoing efforts to address an epidemic of opioid addiction across the United Stated, and in response to a first -of -its -kind “citizen petition” calling for the boxed warnings.

A coalition of health officials from multiple cities, states, and US territories initiated that petition in February, and thousands of concerned community members started an additional online petition. Those petitions were in response to both the increasing combined use of opioids and benzodiazepines and a concomitant increase in the risk of serious side effects and deaths associated with their combined use, according to Baltimore City Health.

As an emergency physician that has seen firsthand alarming trends, one in three unintentional overdose deaths from prescribes opioids also involves benzodiazepines.

In state of Maryland in 2014, benzodiazepines were associated with 19 percent of prescription opioids deaths and 59 percent of benzodiazepine-associated deaths involved prescription opioids. It also noted the growing biological evidence that combining these medications caused sleepiness and slowed breathing, increasing the likelihood of fatal overdose.

It further noted that emergency department visits and deaths involving patients prescribed both opioids and bebzodiazepines have increased significantly over time. From 2004-2011, the rate of nonmedical use-related emergency department visits increased significantly each year, and overdose deaths involving both drug classes during that period nearly tripled on an annual basis.

“Communities have been seeing this trend for some time, but ultimately needed data in order to act today,” FDA Commissioner said.

The current action is just one part of a larger effort to address this epidemic.

Remain focused and deeply committed to contributing to the comprehensive effort to address the opioids epidemic. The FDA "will continue to monitor these products and carefully and take additional actions as needed, and will share updates with the public as necessary as work to address this public health crisis.

The current actions is part of the FDA’s Opioids Action Plan, which is importantly not meant just to cover illicit or abusive use of opioids.