FDA Requires Labeling Update on Opioid-Containing Medicines to Treat Cough and Cold for Children and Adults – APhA submits compounding comments to FDA. – (866) 348-2889
Food and Drug Administration (FDA) 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 because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. In addition, labeling for the medications will be updated with additional safety information for adult use. As noted in a news release, this update will include an expanded Boxed Warning notifying consumers about the risks of misuse, abuse, addiction, overdose, and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.