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  1. Drug Safety and Availability

FDA approves safety labeling changes for opioid pain medicines

[12/15/2023] Today, FDA is announcing final approval and implementation of required labeling updates to continue efforts to address the evolving opioid crisis, and to urge health care professionals to take a more patient-centered approach when prescribing opioid analgesic products.

In April 2023, FDA notified application holders of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) of required safety labeling updates needed for immediate-release (IR) and extended-release/long-acting (ER/LA) opioid analgesics. The required safety labeling updates, originally listed in an April 2023 Drug Safety Communication, include the addition of language stating:

  • the risk of overdose increases as the dosage increases for all opioid pain medicines;
  • IR opioids should not be used for an extended period of time unless a patient’s pain remains severe enough to require them and alternative treatment options continue to be inadequate;
  • many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine; and
  • it is recommended to reserve ER/LA opioid pain medicines for severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine and for which alternative treatment options are inadequate.

The required updates also include a new warning about opioid-induced hyperalgesia (OIH), a condition in which opioid use causes an increase in pain (hyperalgesia) or an increased sensitivity to pain (allodynia). The warning also includes information on differentiating OIH symptoms from those of opioid tolerance and withdrawal.

“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,” said Patrizia Cavazzoni, M.D., Director of the Center for Drug Evaluation and Research. “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.”

FDA’s approval of these labeling updates is a testament to the agency’s continuing progress towards implementing the FDA Overdose Prevention Framework, which provides our vision to undertake impactful, creative actions to prevent drug overdoses and reduce deaths. As we move forward in executing that vision, we remain focused on responding to all facets of substance use, misuse, overdose, and death through the four priorities of the framework, including: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.

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