FDA is taking its toughest stance yet on opioid-containing cough and cold medications for children.
After requiring stricter labeling last year, the agency now says it will no longer allow opioid-containing cough and cold medicines to be prescribed for children younger than aged 18 years.
FDA is ordering the safety labeling changes in cough and cold medicines containing codeine or hydrocodone “because the serious risks of these medicines outweigh their potential benefits in this population,” the agency said in a statement.
Last year, FDA required the addition of the FDA’s strongest warning—a contraindication—to the labeling of prescription codeine products alerting that codeine should not be used to treat pain or cough in children younger than 12 years, due to a specific risk of ultra-rapid metabolism in certain patients.
After the new safety labeling changes are made, the products will be labeled for use only in adults aged 18 years and older.
“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children. We know that any exposure to opioid drugs can lead to future addiction. It’s become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don’t justify their use in this vulnerable population,” said FDA Commissioner Scott Gottlieb, MD, in the statement.
Labeling for the medications is also being updated with additional safety information for adult use. The cough and cold drugs will now include an expanded Boxed Warning—FDA’s most prominent warning—notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.
“The new labeling will provide safety warnings on these products that are consistent with the labeling of other opioid-containing drug products, including immediate-release opioid analgesics and extended-release and long-acting opioid analgesics,” FDA said.