Have FDA Safety Communications Altered Opioid Cough Prescribing Behaviors?

Cough and cold medications containing codeine and hydrocodone have been used in children for years, despite links to misuse and addiction in adolescents, as well as the potential for fatal respiratory depression in adolescents. young children. The United States Food and Drug Administration (FDA) issued a safety communication contraindicating the use of codeine in children aged 0-11 years on April 20, 2017, and then on January 11, 2018, the FDA issued announced that cough and cold medicines containing codeine and 11, 2018, the FDA released a safety communication announcing that codeine and hydrocodone are no longer approved for use in children and adolescents aged 0 to 17. One investigation examined whether these 2 changes were related to changes in prescribing behaviors for cough and cold medications with codeine and hydrocodone in children and adolescents.1

Investigators looked at the 2014-2019 IQVIA longitudinal prescribing data, which includes 92% of all retail pharmacies in the United States. Months of security communications were excluded from the scans.

Form 2014-2019, they found 1,145,357 prescriptions for cough and cold medicine containing codeine and hydrocodone for children and adolescents aged 0-17 years. Almost 60% of these prescriptions were for adolescents. Prescriptions were most often written by family physicians (28.9%), pediatricians (22.2%) and nurse practitioners (10.5%). During the period 2014-2019, codeine-based cough and cold medicines increased from 232,140 in 2014 to 23,008 in 2019. No communication was linked to changes in level or slope in patients. children aged 0 to 11 or adolescents aged 12 to 17. Among hydrocodone-based drugs, prescriptions increased from 132,501 in 2014 to 32,232 in 2019. The 2018 safety communication was not related to level changes, but was related to an increase in slope.

The investigators concluded that a significant drop was observed in drugs based on codeine, 90.1%, and drugs based on hydrocodone, 75.7%. However, FDA safety communications were unrelated to changes in prescriptions. Investigators noted that this contrasted with previous research which had shown that previous safety communications, such as the 2013 FDA communication that contraindicated codeine after tonsillectomy, resulted in changes in prescribing behaviors. . Investigators noted that one potential reason for this could be that those previous safety communications had already started to alter prescribing behaviors. However, with around 55,000 prescriptions still pending in 2019, further efforts to stop opioid cough and cold medications are still needed.


1. Chua KP, Conti RM. Prescriptions of codeine or hydrocodone cough and cold medications for U.S. children and adolescents in accordance with U.S. Food and Drug Administration Safety Communications. JAMA network open. 2021; 4 (11). doi: 10.1001 / jamanetworkopen.2021.34142

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