FDA Announces New Safety Label Changes for Opioid Pain Medicines

While we have seen a decrease in the use of opioids over the past few years, they are still an important treatment option when prescribed responsibly and appropriately. However, they also have serious risks, including misuse and abuse, addiction, overdose, and death.

To help reduce these serious risks, the FDA has developed a vision to undertake impactful, creative actions, one of which was just announced this week. The FDA is requiring several updates to the prescribing information for immediate-release (IR) and extended-release/long acting (ER/LA) opioid analgesics.

While none of these published changes are new or radical from the evolving medical treatment guidelines being discussed over the past few years, having the FDA formalize these tenets brings a higher level of structured guidance. Using the power of the United States government helps drive more consistent levels of compliance throughout the drug supply chain from manufacturers to consumers.

For all immediate-release opioids
The updates state that these products should not be used for an extended period unless the pain remains severe enough to require them, and that alternative treatments continue to be inadequate and that many acute pain conditions treated in an outpatient setting require no more than a few days of opioid pain medicines. These include both surgeries and musculoskeletal injuries.

For all extended-release/long acting opioids
The FDA is recommending that they be reserved for severe and persistent pain that requires an extended treatment period with daily opioid pain medicines and for which alternative treatment options are inadequate.

Information in the Boxed Warning, FDA’s most prominent warning, for all IR and ER/LA opioid pain medicines will be updated to elevate the importance of warnings concerning life-threatening respiratory depression and risks associated with concomitant use of benzodiazepines.

In addition, one of the other most recent actions taken by the FDA was to approve an inhaled nasal spray version of naloxone to be sold over-the-counter without a prescription.

What does this mean for all Workers’ Compensation stakeholders?
This continued formalization by the FDA in the form of treatment guidance allows all Workers’ Compensation stakeholders involved in delivering the most appropriate, restorative care to injured workers, to experience easier identification of patients when a request for appropriate documentation is their responsibility.

The use of opioid pain medicines is at an all-time low but there is a need to remain vigilant and to ensure those patients in need of pain management are not deprived of treatment but are encouraged to obtain an optimum combination of medications and other proven alternative options.