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Prairie State Wire

Sunday, September 14, 2025

FDA requires new warnings on opioid pain medication labels

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Richard C. Anderson, president | Illinois State Medical Society

Richard C. Anderson, president | Illinois State Medical Society

The U.S. Food and Drug Administration (FDA) has announced that it will require new labeling changes for all opioid pain medications. The updated labels will provide more information about the risks linked to long-term use of these drugs.

This decision follows a public advisory committee meeting held in May 2025, where experts reviewed evidence showing significant dangers for patients who take opioids over extended periods. The concerns include misuse, addiction, and both fatal and non-fatal overdoses.

The FDA’s action is based on input from public comments, medical research, and the lack of studies demonstrating the effectiveness of opioids when used long term. These factors led the agency to mandate safety labeling updates so healthcare professionals and patients can make informed choices using current data.

In response to the FDA’s move, the American Medical Association sent a letter expressing support for the new labeling requirements. The association stated: "The American Medical Association emphasized their support of the FDA’s new labeling decision for opioid pain medications that recognizes the importance of ensuring patients have access to all FDA-approved options for pain."

Healthcare providers and others seeking further information can consult resources such as medical legal guidelines and issue briefs related to opioids and substance use disorder. Additionally, six on-demand courses are available that meet state-mandated licensure requirements regarding opioid education.

For questions about these changes or related resources, contact the ISMS Health Policy Research and Advocacy team by email.