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FDA revises labeling to limit pediatric use of prescription cough and cold medicines
Publication year - 2018
Publication title -
the brown university child and adolescent psychopharmacology update
Language(s) - English
Resource type - Journals
eISSN - 1556-7567
pISSN - 1527-8395
DOI - 10.1002/cpu.30276
Subject(s) - hydrocodone , codeine , medicine , medical prescription , heroin , population , opioid , drug labeling , food and drug administration , drug , oxycodone , intensive care medicine , medical emergency , anesthesia , environmental health , pharmacology , morphine , receptor
The U.S. Food and Drug Administration announced last month that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use — including an expanded Boxed Warning, the FDA's most prominent warning — notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.