FDA strengthens warning over opioid painkillers and benzodiazepines

Food and Drug Administration

The US Food and Drug Administration (FDA) is adding a boxed warning to prescription opioid painkillers and cough medicines, and benzodiazepines following evidence the two drug classes are increasingly being prescribed together. 

The FDA carried out research and found the number of patients being prescribed an opioid and benzodiazepine at the same time increased by 41% between 2002 and 2014, equating to an additional 2.5 million people per year receiving both drug classes together. 

In addition, an analysis of hospital emergency department visits between 2004 and 2011 showed a significant increase in admissions involving the concurrent use of both drug classes, from 11 per 100,000 people to 34 per 100,000 people. Deaths caused by overdose associated with the combination also tripled from 0.6 to 1.7 per 100,000 people. 

Both opioids and benzodiazepines are central nervous system (CNS) depressants and, when used together, carry an increased risk of sedation, respiratory depression and death. Another study, published in 2013, also showed that benzodiazepines were involved in 30% of opioid-related deaths in 2010.

In the United States, the medicines currently carry cautions against combining the two, but both will now feature the FDA’s strongest “black box” warning. 

The wording of the warning will also mention the risks of using the drugs alongside other CNS depressants, such as barbiturates, antiepileptic drugs and muscle relaxants, as well as alcohol, as these have also been implicated in opioid-related deaths. 

The FDA says that healthcare professionals should only prescribe a combination of opioid painkillers and benzodiazepines in patients for whom other options are inadequate. In these cases, the duration and dosage should be minimised.

It also advises that opioid cough medicines should be avoided in patients using other CNS depressants, including benzodiazepines and alcohol.

Last updated
The Pharmaceutical Journal, PJ, September 2016, Vol 297, No 7893;297(7893):DOI:10.1211/PJ.2016.20201656

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