FDA to meet with opioid manufacturers to request REMS on associated risks

The US Food and Drug Administration is to meet with manufacturers of the high-strength opioid drugs fentanyl, hydromorphone, methadone, morphine,  oxycodone, and oxymorphone, to request that the firms provide a risk  evaluation and mitigation strategy that shows that the benefits of the  drugs outweigh the risks.

The agency stresses that opioid drugs have benefit when used properly  and are a necessary component of pain management for certain patients,  but that they also have serious risks when used incorrectly. The FDA  believes that establishing a REMS for opioids will reduce these risks,  while still ensuring that patients with legitimate need for these drugs  will continue to have access to them.

Debate on opioids to be opened to the public