No Opioid Cough Meds in Children Under 18, FDA Says

Megan Brooks


January 11, 2018

The US Food and Drug Administration (FDA) has announced new measures to safeguard children from serious risks of opioid ingredients contained in some prescription cough and cold products.

The FDA will require label changes that limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone to adults aged 18 years and older. In addition, the agency will require added safety information highlighting the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the "boxed warning" on labels of these medicines.

"We are taking this action after conducting an extensive review and convening a panel of outside experts. Both of these determined the risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18," the FDA said in a safety communication issued January 11.

"After safety labeling changes are made, these 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 FDA said.

Table 1. Prescription Cough and Cold Medicines With Codeine

Active Ingredient(s) Brand Name(s)
Codeine, chlorpheniramine Tuxarin ER, Tuzistra XR
Codeine, phenylephrine, promethazine Only generics available
Codeine, promethazine Only generics available
Codeine, pseudoephedrine, tripolidine Triacin C


Table 2. Prescription Cough and Cold Medicines With Hydrocodone

Active Ingredient(s) Brand Name(s)
Hydrocodone, guaifenesin Flowtuss, Obredon
Hydrocodone, pseudoephedrine, guaifenesin Hycofenix, Rezira
Hydrocodone, chlorpheniramine Tussionex Pennkinetic, Vituz
Hydrocodone, chlorpheniramine, pseudoephedrine Zutripro
Hydrocodone, homatropine Only generics available

"Given the epidemic of opioid addiction, we're concerned about unnecessary exposure to opioids, especially in young children," FDA Commissioner Scott Gottlieb, MD, said 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 cough and cold in children comes with serious risks that don't justify their use in this vulnerable population," he added. 

"It's critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone. 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," said Dr Gottlieb.

The FDA advises healthcare professionals to reassure parents that cough due to a cold or upper respiratory tract infection is self-limited and generally does not need to be treated. For children in whom cough treatment is necessary, alternative medicines are available. These include over-the-counter products, such as dextromethorphan, as well as prescription benzonatate products.

The labeling changes announced today expand pediatric restrictions put in place by FDA in April 2017, when the FDA advised that children younger than 12 not take tramadol (multiple brands) or codeine, which pose the serious risk for slowed or difficult breathing and death. 

In 2017, the FDA also restricted the use of tramadol and codeine in children older than 12 years and strengthened its label recommendation that breastfeeding mothers not take the two opioids because breastfed children could experience potentially fatal respiratory depression.

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