FDA Issues Warnings For Prescription Opioids and Benzodiaz

By: Samantha Dente

As part of the agency’s Opioids Action Plan, the FDA issued its strongest warning, a required boxed warning, as well as class-wide changes to drug labeling after significant scientific evidence showed the serious risks associated with combining opioid medications with benzodiazepines.[1]

The Opioids Action Plan is an initiative to revise policies to address the prescription opioid abuse epidemic.[2] Benzodiazepines are a class of central nervous system (CNS) depressant drugs.[3] There are about 400 of them currently on the market.[4] Research found that if used at the same time as opioids for pain management, risks include extreme sleepiness, respiratory depression, coma, and death.[5]

The data review found that physicians were increasingly prescribing opioids and benzodiazepines together.[6] The FDA Commissioner has dubbed these findings as a “public health crisis.”[7] Both are widely used drug classes, and when used together have a lethal effect.[8] However, the resulting drug overdoses and deaths are avoidable and preventable, and the FDA’s warning marks a step in the right direction.  The FDA’s actions are consistent with the Affordable Care Act’s public health approach focused on prevention, treatment, and intervention.