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FDA Limits Use of Prescription Cough/Cold Opioids in Pediatric Population

January 19, 2018
Codeine and hydrocodone to be indicated only for those over age 18.

A PPM Brief

In a safety announcement released January 11, FDA stated it is now requiring labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit their use to adults aged 18 and older. The reason for the change, according to the announcement: the risks of these medicines outweigh their benefits in children younger than 18. New boxed warning requirements also call for information to be added regarding these products’ risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing. 

For providers, the clarification means changes in age indications for prescription cough and cold opioid medications. “These products will no longer be indicated for use in children, and their use in this age group is not recommended,” stated the FDA. The agency recommends that physicians instead point caregivers toward alternative medicines such as over-the-counter dextromethorphan, or prescription benzonatate. 

Nearly two years ago, FDA issued similar safety measures for immediate-release and extended-release opioids. 

Last updated on: January 19, 2018
Continue Reading:
CDC Issues Final Guidelines for Opioid Prescribing: PPM Editorial Board Responds
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