FDA Revises Labeling to Limit Pediatric Use of Opioid Cough and Cold Medicines

Today, the FDA announced that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old. Once the labeling changes are made, these products will not be indicated to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Additional safety information for adult use will be added, including risks of misuse, abuse, addiction, overdose and death as well as other side effects from codeine or hydrocodone exposure — slowed or difficult breathing.

The safety labeling changes are based on an extensive review of data and expert advice regarding the pediatric use of opioid containing cough and cold products.