FDA Updates Labeling for Opioid-Containing Medications to Limit Use in Children

Officials with the FDA have announced labeling changes to prescription opioid cough and cold medications that contain codeine or hydrocodone.¹

According to a statement from the agency, the safety labeling changes are intended to limit the use of these medications in children younger than 18 years old, as these products could be associated with risks. After the labeling changes are made, these products will no longer be indicated for use to treat cough in children and will be labeled for use only in adults aged 18 years and older.

Additionally, labels will also include updated safety information for use in adults, including an expanded boxed warning notifying about the risks of misuse, abuse, addiction, overdose, death, and slow or difficult breathing that can result from exposure. The new label’s safety warnings will be consistent with the labeling of other opioid-containing drug products, such as immediate-release opioid analgesics and extended-release and long-acting opioid analgesics.

The new requirements build on previous restrictions enacted by the agency last year, when the FDA required the addition of a contraindication warning to the labeling, to warn against use in children younger than 12 years old due to risk of ultra-rapid metabolism in certain patients.

Listed contraindications also warned mothers against breastfeeding when taking codeine or tramadol medicines, and recommended against use in adolescents between 12 and 18 years old who are obese and have conditions such as obstructive sleep apnea or severe lung disease.

Based on available data and advice reviewed at an expert roundtable and Pediatric Advisory Committee meeting, the FDA determined that the risks of using prescription opioid cough products in children of all ages outweigh the potential benefits. Experts noted that most pediatric cough symptoms that are caused by a cold or upper respiratory do not typically require treatment with these products.

The FDA recommends OTC products, such as dextromethorphan, as well as prescription benzonatate products when cough treatment is necessary.²

Reference

1. FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592109.htm?utm_campaign=01112018_PR_FDA%20acts%20to%20protect%20kids%20from%20serious%20risks%20of%20opioid%20ingredients&utm_medium=email&utm_source=Eloqua. Accessed January 11, 2018.

2. FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older [safety announcement]. FDA’s website. https://www.fda.gov/Drugs/DrugSafety/ucm590435.htm. Accessed January 11, 2018.