The agency’s ruling also added an additional Boxed Warning.
The FDA will no longer allow opioid-containing cough and cold medicines to be prescribed for children younger than 18 years.
The agency 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.
After safety labeling changes are made, the 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.
“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.
At the same time, the FDA is taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products, Gottlieb added.
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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 - the FDA’s most prominent warning - notifying about the risks of misuse, abuse, addiction, overdose, 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.
Last year, the FDA required the addition of 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.
The FDA also held an expert roundtable and convened a meeting of its Pediatric Advisory Committee to look at all the risks associated with the use of codeine- or hydrocodone-containing cough and cold products in children and adolescents younger than 18 years old.
“Experts indicated that although some pediatric cough symptoms do require treatment, cough due to a cold or upper respiratory infection typically does not require treatment. Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits,” FDA said.