1. Pink Sheet

New Opioid Labeling Further Constrains Use, Urges Prescribing Only By Docs ‘Knowledgeable’ About Risks

 
• By Derrick Gingery

US FDA’s mandated labeling changes come after the agency required manufacturers to provide mail-back envelopes for opioid disposal.

opioids
The REMS changes mandating mail-back disposal envelopes are expected to be approved in 2024. • Source: Shutterstock

The latest opioid labeling changes by the US Food and Drug Administration aim to further constrain use, as well as add to the products’ potential risks.

Agency officials ordered several edits to the immediate- and extended-release/long-acting opioid prescribing information on 13 April. Some of the labeling...

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