The Food and Drug Administration announced on Thursday significant labeling changes that will affect all opioid pain medications, including clear information about the risk of addiction, misuse, and overdose in the long term. 

The change comes following two recent observational studies finding a high risk of serious adverse outcomes for patients prescribed opioid pain medications long-term, adding quantitative data to the decades of lived experience of the opioid epidemic across the United States. 

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“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. “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.”

The agency is requiring that opioid prescriptions remove any indications that there is sufficient safety data for long-term use, as well as emphasize that higher doses are associated with increased risk of serious harm.

Opioid prescription labels will also be required to provide information about overdose reversal agents, such as Naloxone. 

Drug companies have 30 days to send their updated labeling information to the FDA for review. 

The press release announcing the changes specifically highlighted that OxyContin “was initially approved without study data supporting its long term use to treat pain.” 

The agency is now requiring “an additional prospective, randomized, controlled clinical trial to directly examine the benefits and risks of long-term opioid use” and “ will be closely monitoring the progress of this clinical trial to ensure its timely completion,” according to the agency’s press release. 

According to the National Institute on Drug Abuse, drug overdose deaths involving prescription opioids rose from 3,442 in 1999 to over 17,000 at their peak in 2017. The figure declined to roughly 13,000 in 2023. 

Overdose deaths involving any opioid reached 79,358 in 2023. 

Health and Human Services Secretary Robert F. Kennedy Jr., a recovered heroin addict, said in a press statement that he has seen “firsthand how devastating addiction is—not just for individuals, but for entire families and communities.”

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“Today’s FDA action is a long-overdue step toward restoring honesty, accountability, and transparency to a system that betrayed the American people.”