The US Food and Drug Administration (FDA) is tightening restrictions on cough syrups in an effort to combat the nation's ongoing opioid epidemic.
A new labeling requirement by the FDA prohibits cough medication from containing codeine or hydrocodone for children under the age of 18, and addresses bigger warnings for anyone over 18.
The FDA says opioids are addictive and can kill, adding their benefits do not outweigh potential risks.
“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children," said FDA Commissioner Scott Gottlieb, MD in a statement. "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 a cough and cold in children comes with serious risks that don’t justify their use in this vulnerable population.”
Cough medication containing codeine will now come with a Boxed Warning – the FDA’s strongest warning. New labels expand pediatric restrictions put in place last year and are consistent with other opioid-containing drug products, adding a warning to adults about the “risks of misuse, abuse, addiction, overdose, and death, and slowed or difficult breathing.”
The requirement comes after the FDA says it conducted an extensive review of data and consulted expert advice, including a roundtable with its Pediatric Advisory Committee.
“It’s critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone,” said Gottlieb.
Medications containing codeine and hydrocodone are not readily available over the counter and, until now, were regulated by the states. Codeine comes in combinations with other medicines, like antihistamines and decongestants, as well as prescription medications to treat certain coughs.
However, the FDA says coughs associated with upper respiratory infections do not require codeine.
Codeine works when the liver converts it to morphine, but people have different interactions with the drug depending on how their body metabolizes it. About one-in-five people are "poor" metabolizers, meaning the drug does not properly metabolize and offers little reprieve from cough and pain symptoms. In contrast, "ultrarapid" metabolizers are able to metabolize codeine to morphine more quickly and completely. For those people, even a normal dose of codeine can result in serious side effects including overdose characterized by sleepiness, confusion, and shallow breathing.
In its 2017 National Drug Threat Assessment, the US Drug Enforcement Agency said the drug landscape in the US has shifted over the last decade and is “reaching epidemic levels”. Drug overdoses are the leading cause of injury death in the US and have risen every year since 2011, outnumbering deaths by firearms, motor vehicle crashes, suicide, and homicide.
The FDA advises parents and caregivers with children currently prescribed medicine containing codeine or hydrocodone to talk with their child’s health care professional about other treatment options