FDA Announces Approval of Opioid Pain Medication Safety Labeling Changes

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This announcement may be considered further progress in the implementation of the FDA Overdose Prevention Framework designed to prevent overdoses and reduce mortality.

The US Food and Drug Administration (FDA) announced that it has approved of newly-required measures related to safety labels for opioid pain medicines, part of a move to support patients’ ability to make better-informed decisions about opioid use.1

Announced December 15, 2023, the FDA’s decision is considered to be part of the agency’s Overdose Prevention Framework. The framework outlines the FDA’s commitment to taking actions to prevent overdoses and decrease drug-related fatalities.

“While FDA understands the importance of ensuring patients continue to have access to opioid analgesics in their pain management regimens, we believe it is equally important to ensure that patients and prescribers are fully aware of all the benefits and risks of treatment with opioid pain medicines,” Patrizia Cavazzoni, MD, director of the Center for Drug Evaluation and Research, said in a statement.

In April 2023, the FDA had informed holders of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) about required updates to safety labeling for immediate-release (IR) and for extended-release/long-acting (ER/LA) opioid analgesics.

These new additions were included in an outline in an April 2023 Drug Safety Communication. The mandatory requirements entailed the addition of language that is designed to emphasize the risk of overdoses rising as opioid dosage rises.

Furthermore, the outline cautions against patients using IR opioids for prolonged periods of time unless they find that persistent severe pain is occurring and alternative treatments are shown to be inadequate.

The FDA recommends limits on outpatient implementation of opioid pain medicine for the purposes of acute pain conditions, further advising the reserving ER/LA opioids for patients with severe and persistent pain when daily treatment with these drugs is found to be necessary and alternative options are shown to be insufficient.

The new mandatory safety updates also introduced a new warning regarding opioid-induced hyperalgesia (OIH), with the warning also clarifying symptoms and distinctions from opioid tolerance and drug withdrawal.

“Approving these class-wide labeling updates facilitates safer use of these medicines and furthers our goal to reduce the risks of nonmedical use and overdose,” Cavazzoni said in the same statement.

The new guidelines, as part of the Overdose Prevention Framework, were designed to emphasize the addressing of all elements of substance use and misuse. They maintain 4 distinct priorities, the first of which involves eliminating the exposure to unnecessary initial prescription drugs, inappropriate prolonged prescribing by clinicians.

The other priorities included the promotion of harm reduction through use of innovation/education and the advancement of evidence-based treatments for substance use disorders. Lastly, the priorities included safeguarding those in the public from diverted, unapproved, or counterfeit drugs that could lead to risk of overdose.


  1. FDA approves safety labeling changes for opioid pain medicines. The U.S. Food and Drug Administration. December 15, 2023. Accessed December 15, 2023.