1. Pink Sheet
  2. >>Drug Safety

FDA's Latest Opioid Move Aims To 'Reset The Conversation' On Benzodiazepine Combo

 
• By Brenda Sandburg

Agency says it now has enough scientific data to act on a citizen petition noting increase in overdose deaths from concomitant prescribing of two drug classes.

FDA once again held a press briefing to note a new development in its efforts to tackle opioid problems. The agency announced on Aug. 31 that it is requiring manufacturers to elevate to a black box warning the existing label warning about the risks of concomitant use of certain opioid medications and benzodiazepines.

The risks, which include extreme sleepiness, respiratory depression, coma and death, have long been known, but agency officials said recent...

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

Most Favored Nation Pricing: Trump Ups Pressure On Voluntary Action, Clarifies Demands

 
• By Sarah Karlin-Smith

The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.

340B Rebate Model Gets HRSA Endorsement; Pilot Program Limited To Medicare Negotiated Drugs

 
• By Cathy Kelly

Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.

Sanofi Secures EU Fast-Track Status For ‘Game-Changing’ Sleeping Sickness Drug

 
• By Neena Brizmohun

If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.