Stricter labeling requirements for opioid-based medicines in the USA

14 April 2023

Amid an ongoing epidemic of opioid abuse in the USA, the country’s medicines regulator has announced safety label changes for opioids aimed at ensuring their safe use.

The US Food and Drug Administration is requiring several updates to the prescribing information for both fast-acting and extended-release opioid-based painkillers.

The labeling requirements will ensure that warnings regarding the danger of overdose are properly outlined, including the fact that the risk increases as the dosage increases.

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