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

Friday, 12 Jan, 2018

The label changes, which will pertain to medicines containing codeine or hydrocodone, will also include safety information for adult use.

The FDA took more steps Thursday to keep opioids out of children's medications, announcing changes to labels for nine types of prescription cough and cold medications containing codeine or hydrocodone, indicating that they should not be given to patients younger than 18. "Both of these determined the risks of slowed or hard breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18", FDA said.

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

The move is in response to the opioid addiction epidemic. The contraindication - FDA's strongest warning - alerted patients that codeine should not be used to treat pain or cough in children younger than 12 years old, due to ultra-rapid metabolism being reported in patients.

Then, last year, the agency warned that the opioids codeine and tramadol could cause life-threatening breathing problems in children and strengthened drug labeling to restrict their use in children younger than 12.

Today's announcement follows an extensive review conducted by the FDA's Pediatric Advisory Committee on the benefits and risks associated with opioid antitussive use in pediatric patients. The administration advises parents children prescribed codeine or hydrocodone to talk their health care professional about alternate treatment options.

The affected products are sold by certain generic drug makers.