As part of the federal government’s efforts to address the opioid abuse epidemic, the U.S. Food and Drug Administration (“FDA”) issued a safety announcement on August 31, 2016, advising against the mixture of opioid medications and benzodiazepines. Specifically, a FDA review found that combining opioid medicines with benzodiazepines or other drugs that depress the central nervous system has resulted in serious side effects, including slowed or difficult breathing and deaths.

Opioids are a class of powerful narcotic medicines that are used to treat severe pain. Opioids such as codeine and hydrocodone also are approved in combination with other medicines to reduce coughing. They also have serious risks including misuse and abuse, addiction, overdose, and death. Benzodiazepines are a class of medicines that are widely used to treat conditions including anxiety, insomnia, and seizures (for example, Xanax, Valium, Ativan and Klonopin).  The FDA conducted and reviewed several studies showing that serious health risks are associated with the combined use of opioids and benzodiazepines, as well as other drugs that depress the central nervous system or alcohol.

In an effort to decrease the use of opioids and benzodiazepines, or opioids and other central nervous system depressants together, the FDA is adding Boxed Warnings – its strongest warnings — to the drug labeling of prescription opioid pain medications, prescription opioid cough medicines, and benzodiazepines (nearly 400 products in total).  This type of warning is intended to call attention to serious or life-threatening risks.  The specific risks include extreme sleepiness, respiratory depression, coma and death. Additional changes include revisions to the Warnings and Precautions, Drug Interactions, and Patient Counseling Information sections of the labeling.

The FDA’s data review showed that physicians have been increasingly prescribing opioids and benzodiazepines together, and this has been associated with adverse outcomes. Among the data reviewed by the FDA, the agency concluded that from 2004 to 2011, the rate of emergency department visits involving non-medical use of both drug classes increased significantly, with overdose deaths (from taking prescribed or greater than prescribed doses) involving both drug classes nearly tripling during that period. Additionally, the number of patients who were prescribed both an opioid analgesic and a benzodiazepine increased by 41 percent between 2002 and 2014, which translates to an increase of more than 2.5 million opioid analgesic patients receiving benzodiazepines.