FDA Limits Opioid Cough Products in Children

FDA Limits Opioid Cough Products in Children

In January 2018, the US Food and Drug Administration announced new requirements for labelling of prescription opioid cough and cold products, limiting their use in children under 18 years of age.  Products containing codeine or hydrocodone are affected by this new restriction.  The FDA cited concerns over misuse and abuse of these products, which can lead to addiction, overdose, respiratory failure and death.  The black boxed warning for these products will be required to include these risks, and the indications for use will be limited to patients 18 years of age and older.  This new change adds to the labeling change made in April 2017, when the use of codeine in patients younger than 12 years of age was restricted.

Announcing these labelling changes, FDA Commissioner Scott Gottlieb, MD, noted in a statement that the risks of addiction, especially in young children, do not justify the use of cough and cold products containing opioids.  Alternative products, including benzonatate (for children > 10 years of age) and a wide range of over-the-counter products, are available to help manage cough symptoms.

Additional information about codeine, hydrocodone and benzonatate can be found in the Top 300 Pharmacy Drug Cards, and information about many non-prescription products can be found in the Top 100 Nonprescription Drug Cards.  If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to Top 100 Nonprescription Drug Cards and the Top 300 Pharmacy Drug Cards flashcards.  If your institution does not provide access, ask your medical librarian about subscribing.

Link to FDA announcement: