FDA Orders Opioid Manufacturers to Update Prescribing Information for Long-Term Use
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.
CDC Proposes Changing Opioid Guidelines
The CDC announced proposed draft updates to the Clinical Practice Guideline for Prescribing Opioids. This draft notice is available to the public and can be commented on until April 11, 2022. The CDC’s opioid guidelines have shaped opioid prescribing policies over the last few years. Changes to these guidelines could impact prescribing behaviors, especially as several states across the country base their treatment guidelines on the CDC’s regulations.
FDA Warns About Dental Problems with Buprenorphine Medicines Dissolved in Mouth
The FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. Dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues. Buprenorphine is used to treat pain as well as to help individuals with opioid use disorder (OUD) reduce opioid use. A new warning for dental problems will be added to drug labels.
