Cough medications that contain opioids like codeine should never be given by kids, and the medicines will now need to be labeled to make that clear, the Food and Drug Administration said Thursday.
They’ll also carry bigger warnings about their dangers to adults, the FDA said.
"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.
Most coughs don’t need any treatment, anyhow, and groups such as the American Academy of Pediatrics have long said honey is better and safer for treating common coughs.
The American College of Chest Physicians recommends against using any cough syrup.
And opioid drugs such as codeine and hydrocodone can not only be addictive — they can kill, too.
“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children,” FDA Commissioner Dr. Scott Gottlieb said in a statement.
“We know that any exposure to opioid drugs can lead to future addiction," he said. "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.”
Codeine is not easily available over the counter in the United States. It's regulated by states, not the FDA, but is a controlled substance that usually must be prescribed. Some products such as Tylenol 3 contain codeine.
Pediatricians have mixed feelings about cough and cold remedies for kids in general. The FDA advises against giving any over-the-counter cold, flu and cough remedies to children under 2, and the Infectious Diseases Society of America says don’t give them to children under 4. The FDA persuaded drug companies to voluntarily take over-the-counter cough and cold drugs for infants off the market in 2007.
Codeine can be especially dangerous for children.
In 2013, the FDA warned doctors not to give codeine to children after having their tonsils out. Codeine converts to morphine in the body and can dangerously slow breathing, especially in the 1 percent to 7 percent of the population whose bodies process codeine especially efficiently.
The FDA will remind parents that most coughs and colds don’t need any treatment at all. Most upper respiratory infections are caused by viruses, and with the exception of influenza, there aren’t any drugs that work against viral respiratory infections.
“It is important for parents and caregivers to understand that a cough due to a common cold often does not need medicines for treatment. If a cough medicine is prescribed, ask your child’s health care professional or a pharmacist if it contains an opioid such as codeine or hydrocodone,” the FDA said.
The American Academy of Pediatrics has been warning about codeine since 1997. The World Health Organization has ditched the drug from its recommended list of painkillers for kids and health agencies in Europe and Canada have restricted codeine use to people older than 12.