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Opioid Manufacturers Required to Strengthen Safety, Warning Information on all Labels


Manufacturers of opioid analgesics will be required to update warning labels and safety information for both immediate release (IR) and extended release/long acting (ER/LA) opioid formulations.

The requirements were detailed in a US Food and Drug Administration (FDA) Drug Safety Communication published April 13, 2023, and also provide additional guidance to help reduce unnecessary opioid prescribing.

©Stock Footage, Inc/Adobe Stock
©Stock Footage, Inc/Adobe Stock

While the Agency notes a substantial decrease in the number of dispensed prescriptions for opioids, there has been no corresponding change in overdose deaths involving the powerful pain relievers. The 18-page mandate continues the FDA's ongoing efforts to adress the nation's opioid crisis, according to the Communication.

"These changes to the prescribing information are designed to inform about appropriate prescribing of opioid pain medicines while also recognizing that they remain an important treatment option in appropriate situations and that undertreatment of pain (including abrupt discontinuations and forced tapering) carries its own risks, including other morbidities and even the risk of illicit substance use for self-treatment," the agency states in an updated FAQ on the new requirements.

The FDA also published examples of the label changes, which will include:

  • Stating that the risk of opioid overdose increases as dosage increases.
  • Stating that IR medications should not be used for extended periods of time; that many acute pain conditions treated in outpatient settings require no more than a few days of an opioid pain medicine.
  • Noting that ER/LA opioids be reserved for severe and persistent pain that requires extended treatment with a daily opioid pain medicine for which alternative options are not adequate.
  • A warning added to both ER/LA and IR medications about opioid-induced hyperalgesia, a condition after prolonged opioid use that increases the severity of pain as well as sensitivity to pain.
  • Updating/reordering information in the Boxed Warning to elevate the importance of cautions regarding life-threatening respiratory depression, and risks associated with concomitant use with benzodiazepines and other CNS suppressants.

Several other sections of the approved label will also require revisions, including Indications and Usage, Dosage and Administration, and Warnings and Precautions sections.

In addition to revised labeling, manufacturers must also update medication guides written for patients and caregivers to include additional information on the risks associated with using opioid analgesics for pain.

The FDA recommends healthcare providers continue to educate patients about the risks, encourage them to read all medication guides and labels thoroughly and continuously reassess the need for opioid prescription and use to reduce risks for addiction.

Reference: FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use. News release. Food and Drug Administration. April 13, 2023. 

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