FDA strengthens warnings on opioids, benzodiazepines
- The Food and Drug Administration this week announced it would require boxed warnings on all opioids and benzodiazepines, cautioning against the risk of combining the two classes of drugs. The changes are part of the regulator's efforts to combat the widening opioid abuse epidemic in the U.S.
- Opioids are highly effective painkillers, and are sometimes used in prescription cough meds. Mixing these drugs with benzodiazepines, typically used for anxiety, can increase the risk of death from overdose.
- Between 2004 and 2011, the rate of emergency room visits resulting from non-medical use of the two classes increased significantly and the number of overdose deaths nearly tripled, according to the FDA.
Abuse of prescription meds, particularly opioid analgesics, has been growing in the U.S. over the last two decades, rapidly becoming a major health concern. Between 1999 and 2014, there were over 165,000 deaths in the U.S. from overdoses linked with prescription opioids, according to the CDC. There were over 14,000 deaths in 2014 alone.
A study in the American Journal of Public Health showed the numbers of benzodiazepine prescriptions have grown in the U.S., from 4.1% of adults filling a benzodiazepines prescription in 1996 to 5.6% in 2013.
At the same time, the researchers saw a jump in the number of overdose death rates, from 0.58 per 100,000 adults to 3.07 per 100,000 adults — a roughly five-fold increase in less than 20 years. Deaths have risen faster than prescription volume, according to one of the study authors in an interview with Stat.
Deaths from overdoses of benzodiazepines and opioids are related to each other, as well. A 2015 study in the BMJ looking at U.S. veterans taking opioid analgesics found around a quarter of the group were also taking benzodiazepines. About half of the deaths from overdoses, however, were among veterans taking both classes of drugs, and higher doses of benzodiazepines were linked with a higher risk of death.
In light of this scientific evidence, the FDA has created an Opioids Action Plan, which has strengthened regulatory oversight of the drugs. Advisory committee meetings are now required before approval of any opioid without abuse deterrence properties, warnings and safety labels have been improved, along with stronger postmarketing requirements and easier access to naloxone to reverse opioid overdose.
“It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together,” said FDA Commissioner Robert Califf in a statement on the new drug guidelines.
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