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

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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 was previously contraindicated in children aged < 6 years. 

An article published in Drugs – Real World Outcomes presented findings from a benefit-risk review of hydrocodone/chlorpheniramine use as an antitussive agent in patients aged 6 to < 18 years. 

Here, 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. 

The results showed that four fatalities had been reported in patients 6 to < 18 years – two of which involved co-suspect medication azithromycin and two were poorly documented. The findings suggested that cough medicines containing opioids can cause harmful side effects in children such as breathing problems. Most fatalities were hydrocodone-related and nine among ten occurred due to overdose in children under 18 years of age. 

Hence, it was inferred that in children, the risks of using hydrocodone for cough relief are greater than any benefits. 

Source: Drugs – Real World Outcomes. 2019 Jun;6(2):47-57.doi: 10.1007/s40801-019-0152-6

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