“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure
to opioids, especially in young children,” FDA Commissioner Scott Gottlieb, M.D.,
said in a news release. “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
In addition to addiction, codeine and hydrocodone have been linked to difficulty breathing,
overdose and death. Last year, the FDA announced codeine is contraindicated to treat pain or cough in children under 12 years. Experts including its Pediatric Advisory Committee have continued to study the issue, leading the FDA to expand its previous warning.
Labels now will indicate these drugs should be used only in adults over 18 years and
will include an expanded Boxed Warning detailing the risks.
In many cases, coughs do not require treatment. For those that do, other medications
are available, including prescription benzonatate products and over-the-counter dextromethorphan
products, according to the FDA.
Officials warned parents some over-the-counter cough medicines contain codeine and
said they are considering new regulations for these products in addition to the prescription
products impacted by today’s actions.
Patients and health care professionals can report adverse events to the FDA's MedWatch
Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report or by calling 800-332-1088.