1. Pink Sheet
  2. >>Drug Safety

Twilight Of The Opioids? Label Updates, Review Changes May Have Less Impact Than Shrinking Pipeline

 
• By Derrick Gingery

Many prescribers don’t read drug labels, meaning they may not see the new warnings and recommendations in the immediate- and extended-release opioid labels, says Brandeis’ Kolodny. Meanwhile, as the Senate advances a bill that would allow comparative review of opioids, they make up a smaller amount of the drug development landscape.

opioid bottles
Many of the pain medications in development are not opioids. • Source: Shutterstock

The US Food and Drug Administration continues to lean on providers to change their prescribing habits with newly implemented opioid labeling changes, but whether the message will reach them remains uncertain.

Language added to the immediate-release opioid label states that the product “should be prescribed only by health care professionals who...

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

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

 
• By Cathy Kelly

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

International Group Aims To Shape The Inevitable Future Of AI In Pharmacovigilance

 
• By Urtė Fultinavičiūtė

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

More from Pink Sheet

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

Respiratory Treatments Hit Hardest By HTA Terminations In England

 
• By Leela Barham

Exclusive analysis by the Pink Sheet explores how non-submissions by pharmaceutical companies to England’s health technology appraisal body are impacting the availability of medicines on the National Health Service.

New Era Begins In Korea: Policy Predictions For Biopharma

 
• By Jung Won Shin

As South Korea's new president immediately gets to work on setting initial policies, essential drug supplies, R&D incentives and AI-driven digital healthcare are among the key topics in focus.