Warnings for Combined Use: Opioids and Benzodiazepines Can Be Fatal

The European Committee for Medicinal Products (CMDh) has decided to update and harmonize product information for medicines containing benzodiazepines and Z-substances. These updates concern warnings related to the concurrent use of these drugs with opioids.

The changes also apply to the product information for opioid-containing medicines. The combined use of these drug classes can lead to significant central nervous system depressant effects, including respiratory depression, coma, and death.

The CMDh's decision follows a similar move by the U.S. Food and Drug Administration (FDA) in August 2016. The FDA had previously mandated similar warnings for prescription opioids and benzodiazepines.

The new warnings require that product information be updated with guidance: concurrent use should be avoided unless no alternative treatments exist. If combination is deemed necessary, the lowest effective dose should be used, and treatment duration should be as short as possible. Patients should be closely monitored for signs of respiratory depression and sedation.