FDA restricts opioid-containing cold medicines for children

Contemporary PEDS JournalVol 35 No. 04
Volume 35
Issue 04

New FDA restrictions on medications for children that contain codeine and other opioids aim to prevent cases of misuse, abuse, and overdose.

The opioid crisis is in full swing, and young adults are among the top abusers of prescription drugs. Now, the US Food and Drug Administration (FDA) is taking a step to try and curb pediatric opioid use in an effort to prevent cases of abuse or overdose.

The FDA’s new rules restrict pediatric opioid prescribing, specifically, in the use of cough and cold medicines containing opioids for children.1 The agency announced the changes to its safety labeling on January 11. The changes affect opioid cough and cold medicines with codeine or hydrocodone for children aged younger than 18 years. The changes mean that these products can no longer be prescribed in children aged younger than 18 years because of the FDA’s concerns that the safety risks of these medications outweigh any potential benefits.

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The FDA says the changes were made after extensive review of safety data and expert advice on the use of pediatric medications containing opioids. The new move expands previous restrictions put in place by the FDA in 2016,2 as well as a move last year to restrict the use of codeine and tramadol to treat pain or cough in children aged younger than 12 years.3

Typically, the FDA’s advisory committees have broken their recommendations on opioid use into 2 pediatric categories-ages 6 to 12 years, and ages 12 to 18 years. This new recommendation covers both groups.

From expert consensus

Tara Rabin, a spokesperson for the FDA, says the agency developed the recommendations based on an expert roundtable4 and a meeting of its Pediatric Advisory Committee.

Rabin says pediatric providers should review the new recommendations and alter their treatment practices accordingly.

“Healthcare professionals should be aware that the FDA is changing the age range for which prescription opioid cough and cold medicines are indicated. These products will no longer be indicated for use in children, and their use in this age group is not recommended,” Rabin says.

Pediatrics isn’t the only population being targeted. The FDA is also updating labeling on adult medications, expanding the Black Box Warning about the risk of misuse, overdose, and addiction related to codeine and hydrocodone.

“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children. 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,” the FDA Commissioner Scott Gottlieb, MD, wrote in a statement on the changes: “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.”

Reassuring parents

The FDA acknowledges that some pediatric cough symptoms may require advanced treatment, but says most do not. The agency encourages parents who have outstanding prescriptions that fall under the new restriction to contact their clinician for updated instruction.

For parents who feel their children need advanced care, Rabin says clinicians should offer guidance and alternatives.

“Healthcare professionals should reassure parents that cough due to a cold or upper-respiratory infection is self-limited and generally does not need to be treated,” she says. “For those children in whom cough treatment is necessary, alternative medicines are available. These include over-the-counter (OTC) products such as dextromethorphan, as well as prescription benzonatate products.”

When asked whether off-label uses will still be permitted, Rabin says there is still some discretion left to the provider.“ From the FDA perspective, with few exceptions, healthcare professionals generally may choose to prescribe or use a legally marketed human drug or medical device for an unapproved or uncleared use when they judge that the unapproved use is medically appropriate for an individual patient,” she says.

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More than anything, however, Rabin says that the FDA is hopeful that the new mandate will increase safeguards for children. 

“It’s important that parents and healthcare providers have the best information available regarding safety and effectiveness of particular medications, as well as understand their risks, to inform the decisions they make about a child’s health,” Rabin says. “Among other priorities related to the opioid epidemic, the FDA is focused on decreasing exposure to opioids, including in children, and continuing to look at how opioid drugs that are already on the market are used, in both medical settings and also illicit ones, and take action where needed.”


1. US Food and Drug Administration. FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older. Available at: https://www.fda.gov/Drugs/DrugSafety/ucm590435.htm. Published January 11, 2018. Updated January 22, 2018. Accessed February 5, 2018.

2. Zimlich R. AAP recommends against codeine use. Contemporary Pediatrics. Available at: http://contemporarypediatrics.modernmedicine.com/contemporary-pediatrics/news/aap-recommends-against-codeine-use. Published October 20, 2017. Accessed February 5, 2018.

3. US Food and Drug Administration. FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. Available at: https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm. Published April 20, 2017. Updated January 30, 2018. Accessed February 5, 2018.

4. US Food and Drug Administration. Use of cough suppressants in children. Expert Roundtable meeting. April 27, 2017. Available at: https://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM570959.pdf. Accessed February 5, 2018.

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