FDA mandates better labels for opioid medications

The Food and Drug Administration is attempting to put a spotlight on the potential risks associated with prolonged use of opioid pain medications by mandating changes to the way those products are labeled.

Following a public advisory committee meeting in May that reviewed data showing serious risks – such as misuse, addiction, and both fatal and non-fatal overdoses – the FDA initiated an additional prospective, randomized, controlled clinical trial to directly examine the benefits and risks of long-term opioid use. That trial is still ongoing.

In the meantime, the FDA is requiring labels featuring clearer risk information, warnings on dosing and drug interactions, clarified use limits, impacts to digestive health and treatment guidance.

WHAT’S THE IMPACT

The new labels will display a summary of study results showing the estimated risks of addiction, misuse and overdose during long-term use. They will also feature stronger warnings that higher doses come with greater risks, and that those risks remain over time.

The labels will remove language that could be misinterpreted to support using opioid pain medications over an indefinitely long period, and they’ll reinforce that long-acting or extended-release opioids should only be considered when other treatments – including shorter-acting opioids – are inadequate. 

Each label will feature a reminder not to stop opioids suddenly in patients who may be physically dependent, as it can cause serious harm. They’ll also feature additional information on medicines that can reverse an opioid overdose. 

To combat drug interactions, the labels will feature “enhanced” warning about combining opioids with other drugs that slow down the nervous system – now including gabapentinoids. 

They’ll also contain new information about toxic leukoencephalopathy – a serious brain condition that may occur after an overdose – and updates about opioid-related problems with the esophagus.  

The FDA sent letters to the relevant applicants outlining the required changes. The companies will have 30 days to submit their labeling updates to the FDA for review.

THE LARGER TREND

According to a 2023 report from the Department of Health and Human Services, Medicare beneficiaries aren't getting the treatments they need for opioid use disorder, and many are dying due to fentanyl, with fewer than one in five enrollees receiving medication to treat their disorder.

The department's Office of the Inspector General found that at least 52,000 Medicare enrollees experienced an opioid overdose in 2022, though the exact number is likely higher, since many beneficiaries didn't receive the medical care that was billed to Medicare.

Opioid-related overdose deaths remain near all-time highs. In 2022, there were an estimated 83,827 opioid-related overdose deaths in the U.S., according to OIG's internal data. Most of these deaths involved synthetic opioids such as illicit fentanyl.