"The U.S. Food and Drug Administration is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18", it said in a statement.
The labeling is also being revised with an expanded Boxed Warning about the risks of misuse, abuse, addiction, overdose and death and slowed/difficult breathing that can result from exposure to the opioids in adult patients.
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. Common side effects of opioids include headache, dizziness and vomiting. "If the medicine prescribed for your child contains an opioid, talk to your child's health care professional about a different, non-opioid medicine", it said.
"We know that any exposure to opioid drugs can lead to future addiction", Gottlieb said.
Products covered by Thursday's announcement included four with codeine, in combination with other agents such as chorpheniramine and promethazine, and five with hydrocodone along with other ingredients.
The move comes after a 2017 decision by the FDA to add its strongest warning - a "contraindication" - to labeling for prescription products containing codeine. Experts noted that most pediatric cough symptoms that are caused by a cold or upper respiratory do not typically require treatment with these products.
It's always important to read medicine labeling, too - even if it's not obtained by prescription.