The FDA said in a news release that after safety labeling changes are made, opioid contatining 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.

The newly updated Boxed Warning on these medicines will also warn adult users "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 agency added.

Given the epidemic of opioid addiction, resaearchers are concerned about unnecessary exposure to opioids, especially in young children. They know that any exposure to opioid drugs can lead to future addiction.  

It has 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.

"It is critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone," Dr. Scott Gottlieb added. "At the same time we're taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products."

The move comes after a 2017 decision by the FDA to add its strongest warning—a "contraindication"—to labeling for prescription products containing codeine. That labeling restricted use to children aged 12 and over "due to a specific risk of ultra-rapid metabolism in certain patients," the FDA explained.

The new rules announced were "based on an extensive review of available data and expert advice," the agency said. They go much further than the 2017 labeling rules—restricting use of codeine-containing products to everyone under the age of 18, and including cough-and-cold products that contain a second drug, the opioid oxycodone.

"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," the agency said. "Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits."

"The opioid epidemic has many origins, but can begin with exposure to [opioids] at young ages," he said. "We know that some children and teens may, in fact, develop a predilection for the 'high' the prescription cough syrups deliver, and subsequently attempt to deceive parents and health care providers regarding the severity of their symptoms to obtain such a prescription."

"Caregivers should also read labels on non-prescription cough and cold products," the FDA said, because "some products sold over-the-counter in a few states may contain codeine or may not be appropriate for young children."