The Food and Drug Administration warned that cough and pain medications containing codeine or tramadol should not be given to children after reports that the drugs caused life-threatening breathing problems.

The agency said that neither of the narcotics should be taken by children younger than 12, teens with a higher risk of breathing problems, or nursing mothers, who can pass unsafe levels of the drugs to their infants through breast milk.

Codeine is commonly used to reduce pain and suppress coughing. It’s found in prescription pain drugs such as Tylenol with Codeine as well as prescription cough and cold drugs, including Fiorinal with Codeine, Prometh VC with Codeine, Triacin-C, and a long list of generics.

In addition, about half of states allow pharmacists to dispense cough and cold medications containing codeine without a prescription to adults.

Tramadol (ConZip, Ultracet, Ultram, and generic) is a prescription medication that is only approved for treating moderate-to-severe pain in adults, but according to the FDA, research shows that doctors sometimes prescribe it for pain in children—after surgery, for example.

“We understand that there are limited options when it comes to treating pain or cough in children and that these changes may raise some questions for healthcare providers and parents,” says Douglas Throckmorton, M.D., deputy center director for regulatory programs at the FDA’s Center for Drug Evaluation and Research.

However, he says that the agency’s decision was made “based on the latest evidence and with this goal in mind: keeping our kids safe.”

How a Cough Remedy Becomes Deadly

Codeine and tramadol belong to the same family of medications as the opioids used in prescription pain relievers such as OxyContin and Vicodin, as well as the illegal drug heroin. They are less potent than other forms of opioids, though, and generally considered safer.

The problem, according to Throckmorton, is that “some people metabolize, or break down, these medicines much faster than usual, causing dangerously high levels of active drug in their bodies.”

That can cause serious side effects, including confusion, extreme sleepiness, and very slow or shallow breathing, or even cause breathing to stop altogether.

“This is especially concerning in children under 12 years of age and adolescents who are obese or have conditions that may increase the risk of breathing problems, like obstructive sleep apnea or lung disease,” Throckmorton says.

It’s also worrisome for nursing infants whose mothers take codeine or tramadol, according to Throckmorton. If a breast-feeding mother is among those whose bodies quickly break down the drugs into their active forms, their breast milk could wind up containing dangerously high levels of opioids.

Strong, New Warnings

The FDA is requiring drugmakers to add new warnings to the official drug labels of prescription products containing codeine or tramadol. Those lengthy, technical documents usually don’t make it to consumers, though, so here’s a rundown of the advice:

• Children younger than 12: Should not be given medications containing codeine or tramadol at all.

• Adolescents 12 to 18: Should not be given the drugs after surgery to remove their adenoids or tonsils or if they have other risk factors that increase their risk of breathing problems, such as being overweight, having sleep apnea (blocked airflow during sleep), or having a weakened respiratory system.

• Nursing mothers: Should not breast-feed while taking drugs containing either codeine or tramadol. In general, the Centers for Disease Control and Prevention recommends that women who are pregnant, may become pregnant, or are breast-feeding avoid opioid medications if possible.

According to the FDA, labels for over-the-counter cough and cold medications containing codeine aren’t changing for now because that requires a different (and more lengthy) process. However, Throckmorton says that the same cautions apply.

In states that allow sales of OTC products with codeine, they are typically kept behind the counter in the pharmacy, to be sold only under the supervision of a pharmacist. Still, the FDA advises parents to review the ingredients of any OTC cough or cold medicine to see whether it contains codeine. If you’re not sure, ask your pharmacist.

Treating Coughs and Colds in Kids

All cough and cold medicines carry risks of side effects, regardless of whether they contain codeine.

That’s why, as part of the Choosing Wisely initiative (of which Consumer Reports is a partner), the American Academy of Pediatrics (AAP) advises against using any cough and cold medications in children younger than 4.

“Even in older children, symptoms such as nasal congestion and cough are generally mild, don’t require medications, and usually last only a few days,” says Marvin M. Lipman, M.D., Consumer Reports’ chief medical adviser.

So what’s a parent of a coughing, congested, and generally miserable kid to do? Lipman recommends the following tried-and-true home remedies, which are backed by some evidence that they help and are far safer than drug treatment.

• Stay hydrated. Drinking plenty of fluids helps thin mucus to prevent thick secretions from getting lodged in the nose and chest.

• Sip something warm. Chicken soup or a hot drink such as decaffeinated tea with honey (see below) can loosen congestion and soothe an irritated throat.

• Try honey. A 2014 review by the Cochrane Collaboration that looked at three studies in children found that honey worked as well as or better than two drugs commonly used in OTC cough drugs—dextromethorphan and diphenhydramine. For children 1 and older, the AAP advises starting with ½ to 1 teaspoon of honey as needed. Don’t give honey to infants younger than 12 months of age because it could contain a bacterium that causes infant botulism.

• Suck on a lozenge. For children 5 and older, sucking on a sugar-free throat lozenge can temporarily relieve an irritated throat and reduce the urge to cough. Don’t give throat drops or lozenges to younger children because they can choke on them.

• Rinse with saltwater. You can buy saline nasal sprays, but steer clear of over-the-counter products labeled “hypertonic”; some studies have found that those more concentrated solutions can irritate nasal passages. You can also make your own solution by combining ½ teaspoon of table salt per 1 cup of warm distilled or sterile water. For babies, put two to three drops in the nostril and use a bulb syringe to suction it out. Older children also can gargle diluted saltwater to ease sore throats.

Consult your pediatrician if your child has: symptoms lasting longer than a week or a fever that persists from more than two days (call the pediatrician right away if your infant younger than 2 months of age has a fever), severe ear pain, or a sore throat accompanied by fever and swollen areas in the neck.

Editor’s Note: This article and related materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

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