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FDA Approves Safety Labeling Changes for Opioid Pain Medicines

The Food and Drug Administration (FDA) has officially granted final approval and implemented mandatory safety labeling updates for opioid analgesic products, marking a crucial step in the ongoing efforts to address the dynamic challenges posed by the opioid crisis. The aim is to encourage healthcare professionals to adopt a more patient-centered approach when prescribing opioid pain medicines.

In April 2023, the FDA issued notifications to holders of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) outlining the required safety labeling updates for both immediate-release (IR) and extended-release/long-acting (ER/LA) opioid analgesics. These updates were initially communicated in an April 2023 Drug Safety Communication, including the addition of specific language to emphasize key points:

  • Risk of Overdose: Highlighting that the risk of overdose increases in tandem with dosage escalation across all opioid pain medicines.
  • Limited Use of IR Opioids: Advising against the extended use of IR opioids unless a patient’s pain remains severe and alternative treatment options remain inadequate.
  • Duration of Treatment for Acute Pain: Emphasizing that many acute pain conditions treated in outpatient settings necessitate no more than a few days of opioid pain medicine.
  • Reserved Use of ER/LA Opioids: Recommending the reservation of ER/LA opioid pain medicines for severe and persistent pain that requires extended treatment with a daily opioid pain medicine when alternative options are insufficient.

The updates also introduce a new warning about opioid-induced hyperalgesia (OIH), a condition in which opioid use leads to an increase in pain (hyperalgesia) or heightened sensitivity to pain (allodynia). This warning includes information to help differentiate OIH symptoms from those associated with opioid tolerance and withdrawal.

Dr. Patrizia Cavazzoni, Director of the Center for Drug Evaluation and Research, emphasized the FDA’s commitment to ensuring that patients and prescribers are fully informed about the benefits and risks of opioid pain medicine treatment. The class-wide labeling updates approved by the FDA align with the agency’s broader vision, as outlined in the FDA Overdose Prevention Framework. The framework focuses on preventing drug overdoses and reducing deaths through primary prevention, harm reduction, evidence-based treatments, and protection from unapproved, diverted, or counterfeit drugs with overdose risks.

This move by the FDA represents a significant stride in promoting the safer use of opioid analgesics and underscores the agency’s dedication to mitigating the risks associated with nonmedical use and overdose.

For further information on the FDA’s efforts in overdose prevention and the broader framework, please visit [FDA’s official website ].


Joan David-Leonhard

Joan David Leonhard is a recent Pharm.D graduate with a strong passion for the pharmaceutical industry and a particular interest in pharmaceutical media and communication. Her brief internship experience includes roles in pharmacy where she built strong patient-pharmacist relationships and a pharmaceutical media internship where she actively contributed to drug information articles, blog posts, social media engagement, and various media projects.
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