The Food and Drug Administration says children under 12 should not be given prescription medicines that contain codeine or another narcotic, tramadol, and that such drugs can also be dangerous to youth between 12 and 18.
On Thursday, the FDA said it will require that prescription drugs containing codeine or tramadol carry a warning on the label against using them in children under 12 or in women who are breast-feeding. The agency cited evidence that the drugs could cause dangerously slowed breathing in some children, which could lead to death.
Multiple prescription drugs contain codeine or tramadol. For example, the painkiller Tylenol 3 contains acetaminophen and codeine. Drugs containing codeine already carry a black-box warning against using it to treat pain in children who have their tonsils removed.
"This is something we've been watching for several years," says Douglas Throckmorton, the deputy director for regulatory programs at the FDA's Center for Drug Evaluation and Research. "They are powerful, effective medicines when used right [but] they can cause a lot of harm when they're not."
The agency also warned against using the drugs in young people between 12 and 18 who are obese or have breathing problems such as sleep apnea or lung disease.
The new warnings did not further restrict over-the-counter medicines that contain codeine, such as popular types of cough syrup and medication marketed for cold and flu symptoms. The FDA recommends that parents talk to a doctor before giving their children such drugs and notes that colds and coughs in kids "are generally mild and go away in a few days, so they may not need to take any medicine."
Thursday's announcement was a partial acceptance of 2015 recommendations by an independent advisory committee that recommended the agency restrict prescription of codeine-containing drugs for children and also voted overwhelmingly against over-the-counter sale of codeine-containing cough syrup for children.
At the time, pharmacist Maria Pruchnicki, an associate professor at the Ohio State University College of Pharmacy, told NPR's Rob Stein, "My concern, were I to be prescribing codeine in children, would be that I would, frankly, kill them."
As Stein reported, the FDA is not required to follow the committee's 2015 advice, although the agency generally acts in line with advisory committee recommendations.
In this case, the agency did act on prescription drugs but did not act on the over-the-counter recommendation.
It was unclear why more than a year passed between the committee recommendations and their partial adoption by the agency. In a press briefing, Throckmorton said the agency had received "additional information."
Diana Zuckerman, president of the consumer group National Center for Health Research, called the move a "long-overdue step to protect our children":
"The science is clear, so why did it take almost 18 months since the FDA's public meeting on the exact same issue? FDA needs to do more to warn patients about the known risks of medical products as soon as data are available. A change in the label is important, but unfortunately many doctors and patients don't read these labels. We need a public education campaign to warn parents and nursing women about these risks."
In 2015, the FDA acknowledged that although tramadol is not approved for use in children, it is used off-label to treat pain in kids. In that warning, the agency noted that some people are what's known as ultra-rapid metabolizers of tramadol and codeine. Those people have a variant of a liver enzyme that breaks down the drugs more quickly, leading to a rapid and potentially dangerous spike in the level of active opioids in the bloodstream.
The drugs can make their way into breast milk in nursing mothers and potentially harm infants, the FDA warns. The proportion of people with the enzyme variant, which is genetic, is thought to be between 1 and 10 percent.
"Because we can't easily determine which children or nursing mothers specifically are at greater risk of ultra-rapid metabolism of codeine or tramadol, we are requiring manufacturers ... to make important labeling changes to protect those children who are at the greatest risk," explains Throckmorton.
As for future action on over-the-counter medicines that contain codeine, the American Academy of Pediatrics has made its position clear.
In a report published last year in the journal Pediatrics, members of the academy's committee on drugs wrote that although over-the-counter cough and cold medicines containing codeine were available in 28 states and Washington, D.C., "neither the value of suppressing cough nor the effectiveness of codeine in children with acute illnesses has been shown."
Regulators in Europe, Canada and Australia have all restricted the use of medicines containing codeine for children. According to the FDA's public label database, more than 100 medications containing codeine are approved for sale without a prescription in the U.S.
RACHEL MARTIN, HOST:
For years, evidence has been mounting that drugs containing codeine or the narcotic tramadol can be dangerous for children. The Food and Drug Administration now says kids under 12 should not take prescription medications that contain those narcotics. Here's NPR's Rebecca Herscher.
REBECCA HERSHER, BYLINE: These new restrictions don't apply to over-the-counter medications, like cough syrups. But all prescription medicines that contain codeine or the narcotic tramadol will now carry a warning on the label explaining the dangerous symptoms they can cause. Dr. Judith Racoosin is the FDA's deputy director of safety for the division that handles anesthesia, pain meds and drugs with addictive properties.
JUDITH RACOOSIN: The symptoms are going to be the same as associated with any kind of opioid overdose. So that is sleepiness. That is respiratory depression, difficulty breathing.
HERSHER: Which can lead to death. Between 1969 and 2015, the FDA says 24 people under 18 died after taking medicines with codeine in them. And there were 40 cases reported of serious breathing problems in kids. The danger appears to be bigger for younger children. Of those who died, 21 of them were under 12 years old. The new restrictions also apply to women who are breastfeeding and to adolescents who have breathing problems, like lung disease or sleep apnea. Diana Zuckerman is the president of the consumer group the National Center for Health Research.
DIANA ZUCKERMAN: Well, it's long overdue.
HERSHER: More than a year ago, an independent advisory committee told the FDA it should take this action. And Zuckerman is frustrated it's taken so long. She says the consensus is that the risks of codeine outweigh the benefits for kids.
ZUCKERMAN: You know, just remember when kids have colds, those colds are going to go away by themselves.
HERSHER: The FDA is still considering changes for over-the-counter drugs that contain codeine. Some states have taken their own action by putting age restrictions on who can buy them.
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ZUCKERMAN: I think the best advice for parents is to remember that they shouldn't be giving medications to the children if the children don't really need it.
HERSHER: For parents who want to avoid codeine, most popular meds for cough and flu symptoms list their active ingredients prominently on the front of the package. Rebecca Hersher, NPR News. Transcript provided by NPR, Copyright NPR.