1. Pink Sheet

Opioid Labeling Instructions On Naloxone Are Compromise In Co-Prescribing Debate

 
• By Derrick Gingery

US FDA says opioid and opioid use disorder treatment labels should suggest providers discuss naloxone availability with patients and caregivers and consider co-prescribing to patients at high-risk of overdose, but it does not mandate co-prescribing, the most aggressive (and costly) option that had been considered.

An ampoule Opioid next to it is a note written in English Opioid epidemic. All around, many tablets and syringes are scattered.
The FDA Drug Safety Communication also recommends prescribing naloxone to patients with children or other household members at risk of accidental ingestion or overdose. • Source: Shutterstock

US Food and Drug Administration has decided to recommend a discussion of naloxone when prescribing an opioid, stopping short of a potentially costly co-prescribing requirement that had been narrowly recommended by an advisory committee.

The agency will require opioid and opioid use disorder product labels to include language recommending “that as a routine part...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Drug Safety

More from Pink Sheet

New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

UK Pilots Faster Setup Of Early Phase Oncology Trials

 
• By Vibha Sharma

Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.

US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 
• By Bridget Silverman

The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.