FDA to require new safety warnings for opioids

The US Food and Drug Administration (FDA) last week announced new labeling updates and safety warnings for immediate-release (IR) and extended-released/long acting (ER/LA) opioids stemming from reports about patients’ increased sensitivity to pain or greater pain with use of these medications.

The reports indicated that a new warning was needed for opioid-induced hyperalgesia (OIH), which is when an opioid that is prescribed for pain causes an increase in pain, called hyperalgesia, or an increased sensitivity to pain, called allodynia.

“Extended-release/long-acting (ER/LA) opioid pain medicines have unique risks and should be used only for those with severe and persistent pain,” FDA announced.

FDA stated that “although OIH can occur at any dosage, these may occur more frequently with higher doses and longer-term use. This condition can be difficult to recognize and may result in increased dosages that could worsen symptoms and increase the risk of respiratory depression.”

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research (CDER) said “these labeling updates are an outcome of our comprehensive work to review the labeling of opioid analgesics and make modifications that will support safer use of these medicines, as well as shared decision-making between health care providers and patients regarding balanced pain management.”

The new labeling will go in the “boxed warning” section of all IR and ER/LA opioid pain medicines to “elevate the importance of warnings concerning life threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS).”

Manufactures must state on the labeling that the risk of overdose increases as the dosage increases for all opioid pain medicines, and that 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.

The labeling must also note that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine. It also recommends reserving ER/LA opioid pain medicines for severe and persistent pain that requires an extended treatment period.

This action is part of the agency’s implementation of the FDA Overdose Prevention Framework which aims to prevent drug overdoses and reduce deaths through substance misuse. (RELATED: FDA targets illegal online opioid retailers in new overdose prevention framework, Regulatory Focus 30 August 2022)

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FDA to require new safety warnings for opioids

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