FDA Drug Safety Podcast: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older

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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin, Advanced Practice Nurse.

On January 11, 2018, FDA announced that it is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18. We are also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the Boxed Warning, our most prominent warning, to the drug labels for prescription cough and cold medicines containing codeine or hydrocodone.

We are taking this action after conducting an extensive review and convening a panel of outside experts.

Health care professionals should be aware that these products will no longer be indicated for use in children, and their use in this age group is not recommended. Health care professionals should also reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated. For those children in whom cough treatment is necessary, alternative medicines are available, including over-the-counter (or OTC) products such as dextromethorphan, as well as prescription benzonatate products.

Codeine and hydrocodone are available in combination with other medicines, such as antihistamines and decongestants, in prescription medicines to treat coughs and symptoms associated with allergies or the common cold. Other non-opioid prescription and OTC medicines are available to treat these symptoms.

Other Boxed Warnings and Warnings and Precautions will also be added to the label for prescription cough and cold medicines containing codeine or hydrocodone, to be consistent with the safety issues described in the labels of prescription opioid pain medicines. We previously communicated about these safety issues for immediate-release opioid pain medicines and extended-release and long-acting opioid pain medicines. Today’s action is for opioid cough and cold medicines requiring a prescription. Some codeine cough medicines are available OTC in a few states, and we are also considering regulatory action for these products.

Report side effects involving these medicines to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing information for health care professionals and the Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

And follow us on Twitter @FDA_Drug_Infodisclaimer icon for up to the minute important drug information. Know the moment it happens. Thank you for listening.

Page Last Updated: 01/16/2018
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