FDA orders changes to opioid labels amid new safety concerns

WASHINGTON, D.C. — The U.S. Food and Drug Administration will require major safety updates to all opioid pain medication labels, a move the agency says will better warn patients and doctors of the risks tied to long-term use.

The change, announced Thursday, follows years of criticism over the handling of the opioid epidemic, which has claimed nearly one million American lives. The new labeling will emphasize the dangers of misuse, addiction and fatal overdoses, while removing language that could be interpreted as endorsing indefinite opioid use, the FDA said.

FDA Commissioner Marty Makary called the decision a “long-overdue” step toward restoring trust in the system.

“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” Makary said in the announcement. “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 updated labels will now feature:

• Clearer data on addiction and overdose risk
• Stronger dosing warnings for high or prolonged use
• Guidance for safe discontinuation to prevent harm from sudden withdrawal
• New details on drug interactions and overdose complications, including rare brain and digestive issues

The FDA said it has also ordered an additional randomized, controlled clinical trial to directly examine the benefits and risks of long-term opioid therapy, with the agency pledging close oversight of the study’s timeline.

“Ohio is considered to be one of the states where the opioid crisis hit hardest, but that crisis came to a head years ago now,” said Courtney Astolfi, an editor at cleveland.com and The Plain Dealer. “Still, any new requirements aimed at reigning in the ill effects of overuse or addiction would likely be seen by the public as a positive step forward.”

The labeling overhaul comes amid the ongoing opioid epidemic, which began in the late 1990s when drugmakers aggressively promoted prescription opioids as low-risk treatments for chronic pain. Prescriptions surged in the 2000s, driving widespread misuse and addiction, according to the Centers for Disease Control and Prevention.

By the early 2010s, tighter prescribing rules pushed many users toward heroin, and the crisis entered a deadlier phase after 2013 with the rise of illicit fentanyl and synthetic opioids, the National Institute on Drug Abuse said. The drugs are far more potent and often mixed with other substances, fueling a sharp increase in overdoses. Nearly one million Americans have died from opioid overdoses since 1999, and more than 80,000 deaths occurred in 2022 alone, with fentanyl involved in roughly two-thirds of cases, the institute said.

According to the FDA, the federal responses have included stricter prescribing limits, expanded access to naloxone and other overdose-reversal drugs, and new requirements for clinical trials and post market safety studies. The FDA said Thursday it is also mandating a randomized clinical trial to evaluate the benefits and risks of long-term opioid use.