FDA Labels Opioid Cough Meds Unsafe for Kids

FDA Commissioner Scott Gottlieb

The FDA has determined that opioid cold and cough medicines should not be used for treating children under the age of 18.

According to a statement released on January 11, new labeling requirements dictate that a warning indicating the medication is only for use in adults 18 and older must be included on packaging for opioid cold and cough medicines.

In addition to stipulating that these opioid cold and cough medicines should only be used for adults 18 and older, the warning labels for these medications is also being expanded to include notifications regarding the potential for opioid abuse, addiction, and overdose.

In the statement, FDA Commissioner Scott Gottlieb cited the opioid crisis as a primary reason for the updated labels, stating that even a single exposure to such substances can result in addiction. The FDA has concerns regarding “unnecessary exposure to opioids,” Gottlieb said, especially in those under the age of 18.

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Among the opioid cold and cough medicines included in the new labelling requirements are those which contain the opioids hydrocodone and codeine. However, Gottlieb also stated that the FDA was “taking steps” to provide guidance to parents who were concerned about cold treatment without the opioid medications.

The statement explains that the decision to add additional warnings to opioid cold and cough medicine labelling requirements builds upon a decision made in 2016 which expanded pediatric restrictions on codeine-based medications. The statement also states that FDA decided upon the warnings based on guidance from the its Pediatric Advisory Committee.

Concluding the statement was an affirmation of the FDA’s commitment to fighting the opioid crisis, including several stated goals for the agency, such as the prevention of new addiction, improving enforcement, developing new techniques for the treatment of pain, and providing addiction recovery treatment for those struggling with an opioid use disorder.