FDA: Opioid Cough And Cold Medicine Not Safe For Kids

By Paul Gaita 01/16/18

New FDA safety labels will indicate that doctors should no longer prescribe medications containing codeine or hydrocodone to those under 18. 

Mother pouring cough syrup onto a spoon as small child watches

Cough and cold medications containing codeine or hydrocodone will be required to showcase new labeling which indicates that they are unsafe for use for children under the age of 18, according to the U.S. Food and Drug Administration (FDA).

The agency issued an announcement on January 11 that outlined the new safety label revisions, which will indicate that these products are no longer safe to prescribe to children, given their potential for health risks.

Labeling for prescription opioid cough and cold medication for adults will also include updated safety information that will indicate the risks of using opioid medication, including misuse, dependency and the possibility of death. The requirement is the latest in a series of public warnings and investigations by the FDA into the use of codeine and other opioids in treating children for colds or post-dental procedure pain.

The FDA's announcement notes that after the proper safety labeling updates are made, the 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 labeling will also be expanded to include safety information for adults, including an expanded boxed warning—a designation, also known as a "black box warning," which is the agency's most prominent warning and is intended to draw users' attention to potential life-threatening side effects—that will identify the various risks involved in exposure to codeine and hydrocodone, including slowed or difficult breathing and death.

In a statement on the FDA's website, FDA Commissioner Scott Gottlieb 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. 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."

The FDA has conducted several investigations into the risks of using medicines with codeine to treat cough and cold symptoms in children under 18 years old. The agency issued a black box warning in 2013 against prescribing codeine to children as pain management after having their tonsils or adenoids surgically removed—though as CNN noted, a 2015 study by the journal Pediatrics found that about one in 20 children undergoing those procedures was still receiving a post-surgery codeine prescription.

In 2017, the agency restricted the use of medicines containing codeine and tramadol to children younger than 12, and recommended against their use by women who are breastfeeding. A meeting between the agency and the Pediatric Advisory Committee in August 2017 preceded the restrictions issued on January 11.

CNN also noted that the FDA is advising parents whose children have been recently prescribed a cough or cold medicine containing codeine or hydrocodone to talk to their doctors about alternative treatment possibilities. The agency also stated that some products sold over the counter in several states may contain codeine, and advised parents to check the label for contents.

Please read our comment policy. - The Fix

Paul Gaita lives in Los Angeles. He has contributed to the Los Angeles Times, Variety, LA Weekly, Amazon.com and The Los Angeles Beat, among many other publications and websites.