FDA Orders New Safety Labels for All Opioids, Seeks Schedule 1 Ban on 7-OH Kratom

The FDA announced that new safety labels are required for all opioid pain medications to “better emphasize and explain the risks associated with their long-term use.” The FDA held a public advisory committee meeting in May reviewing serious risks, which include misuse, addiction, fatal, and non-fatal overdoses.

Of the 105,000 drug overdoses in 2023, about 76% (80,000) were from opioid drugs. The number of deaths from opioid overdoses is 10 times higher than it was in 1999, and that is with a 4% decline from 2022 to 2023.

The new safety labels will be required to include:

-“A summary of study results showing the estimated risks of addiction, misuse, and overdose during long-term use.

– Dosage warnings

– Removing language which could be misinterpreted to support using opioid pain medications for indefinite duration

-Labels will reinforce that long-acting or extended-release opioids should only be considered when other treatments, including shorter-acting opioids, are inadequate.

-A reminder not to stop opioids suddenly in patients who may be physically dependent, as it can cause serious harm.

-Additional information on medicines that can reverse an opioid overdose.

-Enhanced warning about combining opioids with other drugs that slow down the nervous system—now including gabapentinoids.

-New information about toxic leukoencephalopathy—a serious brain condition that may occur after an overdose.

-Updates about opioid-related problems with the esophagus.”

Purdue Pharma and the Sackler family reached a $7.4 billion settlement for their role in the opioid epidemic that began in the mid-90s with increased prescriptions of OxyContin for long-term use. The story of OxyContin and Purdue Pharma is the subject of multiple non-fiction drama miniseries, including Dopesick on Netflix.

“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This long-overdue labeling change is only part of what needs to be done — we also need to modernize our approval processes and post-market monitoring so that nothing like this ever happens again.”

The FDA based the new safety labels upon data from a prospective, observational cohort study that examined the risks of addiction, misuse, and abuse in patients using opioid drugs long-term. Over the course of 12 months and two cohorts, about 9% of patients met the criteria for prescription opioid abuse, which is to use the medication for a nontherapeutic purpose. 22% met the criteria for opioid misuse, which is using the medication for a therapeutic purpose but not following the directions on the label. Having a history of substance abuse was the strongest and most consistent risk factor.

A retrospective, observational cohort study was also conducted to estimate the risk of opioid-involved overdose or opioid overdose-related death (OOD). The researchers concluded, “The five-year cumulative incidence estimates for OOD ranged from approximately 1.5-4% across study sites. Approximately 17% of first opioid overdoses observed over the entire study period (5-11 years, depending on the study site) were fatal.” A higher baseline dosage of opioid medication was associated with a higher likelihood of OOD.

“I know firsthand how devastating addiction is—not just for individuals, but for entire families and communities,” said HHS Secretary Robert F. Kennedy, Jr. “Today’s FDA action is a long-overdue step toward restoring honesty, accountability, and transparency to a system that betrayed the American people.”

About 480,000 worldwide deaths in 2019 are related to opioid use, with about 125,000 dying from opioid overdose. 2.1 million people in the United States have opioid use disorder (OUD), which is about one out of 122 adults in the country. Fentanyl is the most common opioid that leads to overdoses.

12.7 million adults (6.4%) between the ages of 18 and 64 filled at least one opioid prescription in 2020-2021. 3.6 million (1.8%) refilled opioid prescriptions at least four times over the year during the same time period. Women were more likely than men to fill opioid prescriptions.

59.2 people out of 100 were prescribed opioids in Maricopa County, Arizona, in 2017, which shows heavier use of these drugs in certain regions.

Secretary Kennedy and Commissioner Makary have also announced they intend to crack down on 7-OH Kratom, a type of opioid that Kennedy said has been marketed to children with gummies and ice cream cones.

“I became an addict because it was so available, but I still had to go to Harlem, or I had to go to the South Bronx, or I had to go to the Lower East Side….and now you can go to ANY gas station,” Kennedy said. “They’re around military reservations in our country. They’re putting them around schools, they’re putting them in our poorest neighborhoods, and now they’re putting them in every gas station. And they’re marketed for children. They’re gummy bears, they’re bright colors, they’re candy flavored. This is really a sinister, sinister industry.”

The FDA has asked the Department of Justice to reclassify 7-OH Kratom as an illicit schedule 1 controlled substance.

“Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught flat-footed again,” said FDA Commissioner Marty Makary, M.D., M.P.H. “7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic.”