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Upcoming Events in the Pain Community

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FDA Advisory Meeting High Dose Opioids

The U.S. Food and Drug Administration announced  that the agency will be holding a public advisory committee meeting on June 11 and 12 to discuss safety concerns that have been raised concerning the safe prescribing and use of the higher-range doses of opioids. 

The meeting will be held on 

June 11, 2019, from 8 a.m. to 5 p.m. and 

June 12, 2019, from 8 a.m. to 5 p.m.

The FDA meeting will include a discussion about:


  • the specific clinical use of higher product strengths and daily doses and medical situations that may warrant pain management with these medications as well as factors influencing prescribing practices;
  • identifying specific patient populations for whom there may be clear benefits in prescribing these medications at higher doses;
  • the magnitude and frequency of harms associated with opioid analgesics at higher product strengths and daily doses, relative to lower strengths and daily doses, including the role of opioid dose in adverse health outcomes in both patients and in others who may access the drugs – such as those at risk of developing addiction or experiencing a fatal overdose;
  • potential FDA actions that may address these issues, as well as the expected impact any such actions may have on patients and public health more broadly.


The FDA intends to make background material available to the public no later than two business days before the meeting.

Submit Your Comments

Comments received on or before May 28, 2019 will be provided to the committees. Comments received after that date but by June 30, 2019 will be taken into consideration by FDA.



https://www.regulations.gov/document?D=FDA-2019-N-1646-0001

Submit Your Comments