The FDA announced that all opioid pain medications must update their safety labeling information to better emphasize the risks associated with long-term use. These changes are intended to help health care professionals and patients better understand the benefit-risk profile of opioid pain medicines and make more informed decisions. The updated labeling change reflects robust data from two large FDA-required observational studies, along with public comments, medical research and recognizing the absence of adequate and well-controlled studies on long-term opioid effectiveness. The labeling changes will include updates for clearer risk information, dosing warnings, clarified use limits, treatment guidance, safe discontinuation, risks of overdose, and more.
