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Hydrocodone/chlorpheniramine is a prescription opioid licensed in the USA for the relief of cough and upper respiratory symptoms associated with allergy or cold in adults, previously contraindicated in children aged &lt; 6 years. We present findings from a modern benefit risk review of hydrocodone/chlorpheniramine use as an antitussive agent in patients aged 6 to &lt; 18 years. A cumulative search of the manufacturer's pharmacovigilance database covering 1 January 1900-7 August 2017 identified all individual case safety reports (ICSRs) associated with product family name "hydrocodone/chlorpheniramine." The search was inclusive of all MedDRA system organ classes, stratified by age (&lt; 18 years). A comprehensive review of the scientific literature was conducted on safety and efficacy of opioids for pediatric treatment of cough. Three hundred and ninety-one ICSRs associated with hydrocodone/chlorpheniramine were identified; 35/391 ICSRs were in patients &lt; 18 years of age; 18 were considered serious. Four fatalities were reported in patients 6 to &lt; 18 years; two fatalities involved co-suspect medication azithromycin and two were poorly documented. Our literature search identified no robust efficacy data for hydrocodone/chlorpheniramine in the relief of cough and upper respiratory symptoms associated with allergy or cold in patients aged 6 to &lt; 18 years. As we found no evidence of hydrocodone/chlorpheniramine efficacy in the pediatric population, we conclude that the benefit risk profile is unfavorable. This evidence contributed to the US Food and Drug Administration's (FDA's) recent decision that hydrocodone-containing cough and cold medications should no longer be indicated for treatment of cough in patients &lt; 18 years, highlighting the value of proactive re-evaluation of the benefit risk profile of older established drugs. Plain Language Summary People often use medicines containing opioids to treat cough symptoms. The US Food and Drug Administration (FDA) recently decided that cough medicines containing opioids should not be used by children under 18 years old. Part of this decision was a review of the benefits and risks of using cough medicines that contain the opioid hydrocodone in children.Why was this review carried out? Most cough medicines that doctors can prescribe were approved several decades ago. Since then, rules for the approval of medicines have become stricter. In this review, researchers looked at the safety of hydrocodone, and how well this opioid relieves cough symptoms in children. Up-to-date information and modern research methods were used.The two key pieces of evidence found were: We could not locate any clinical trials providing robust evidence for the use of hydrocodone for cough relief in children under 18 years of age. (Outside the scope of this review, a number of clinical trials of hydrocodone-containing cough medicines in adults aged 18 years and over have shown the medicine to be effective in these patients.) Cough medicines containing opioids can cause harmful side effects in children such as breathing problems. In the research reported here, ten children died after taking a hydrocodone-containing cough medicine. Nine of these deaths were due to overdose. This evidence was used to draw the following conclusions: In children under 18 years of age, the risks of using hydrocodone for cough relief are greater than any benefits. Older medicines should be reviewed regularly to look at their safety and how well they are working using up-to-date evidence.

A Benefit Risk Review of Pediatric Use of Hydrocodone/Chlorpheniramine, a Prescription Opioid Antitussive Agent for the Treatment of Cough