The U.S. FDA is now requiring opioid pain medications to feature labeling that better expresses the risks of long-term usage.
These labeling requirements are the result of a public advisory committee meeting in May that considered data from two large observational studies looking at the risks of taking opioids for an extended time. The studies revealed risks including misuse, addiction, and overdose, including almost one million deaths in the U.S. alone during the opioid epidemic. The meeting also took public comments and medical research into account as well as the fact that there have been no adequate studies on the long-term effectiveness of opioids.
Companies who need to include the new labeling on their products will receive a letter from the FDA describing the necessary changes. They will have 30 days to send their proposed labeling to the FDA for review.
In addition to these labeling requirements, the FDA will be closely monitoring a randomized, controlled clinical trial on the benefits and risks of long-term opioid use.