FDA Orders Label Changes for Opioid Cough and Cold Medications

The U.S. Food and Drug Administration will order changes to labeling information for opioid cough and cold medications to limit their use to adults aged 18 years and older. It will also require that new safety information be added to highlight the risk for addiction, abuse, overdose, and other dangerous potential side effects for all patients. Codeine-containing products like Tuxarin ER and Tuzistra ER, as well as products that contain hydrocodone (eg, Flowtuss, Rezira) will no longer be indicated for use in any pediatric population. The FDA says it’s taking this action on the advice of a special panel it convened to investigate ways to curb rampant opioid misuse in the U.S. The agency also recommended that providers counsel patients seeking medication that cough due to a cold or upper respiratory tract infection is self-limited and generally does not need to be treated.