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Opioid Cough Restrictions: Pediatric Use, And Postmarket Studies, Likely Limited

Executive Summary

US FDA advisory committee strongly recommends antitussives containing codeine or hydrocodone not be used by patients under age 18 years old, pointing to lack of modern evidence of benefit and known risks of respiratory depression and misuse. Expanding the contraindicated population could get some product sponsors off the hook for required pediatric studies.

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