Summary Safety Review - Hydrocodone-containing products - Assessing the Risk of Serious Breathing Problems (respiratory depression) in Children and Adolescents
Review decision
A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Issued: 2016-07-28
Product
Hydrocodone-containing products
Potential Safety Issue
Serious breathing problems (respiratory depression) in children and adolescents
Overview
Use in Canada
- Hydrocodone is a prescription opioid drug used to reduce exhausting, dry (non-productive) cough and has been marketed in Canada since the late 1950s.
- In Canada, some hydrocodone-containing products are recommended for use in children under 6 years of age. However, in recent years, the number of prescriptions (new and refills) of hydrocodone in children and adolescents has declined from 42,000 in 2010 to 28,000 in 2014.
Safety Review Findings
- At the time of the review Health Canada assessed a total of 7 reports, in children and adolescents, of hydrocodone use related to serious breathing problems or related to hydrocodone overdosea. Two reports involved children that were 7 and 15 years old; one was considered related to the hydrocodone use but there was not enough information provided in the other report to assess it. There were five reports in children under 6 years of age and upon further analysis three were considered related to the hydrocodone use. Death was reported in 2 of these (involving a 2 year-old and 5 year-old); one was considered related to the hydrocodone use but there was not enough information provided in the other report to determine if the death was due to hydrocodone use.
- A review of the published literature identified one international case of a 3-year old child that experienced serious breathing difficulties after use of hydrocodone and later died. Upon further review, the event was considered to be due to hydrocodone use.
- In the majority of the cases, including the fatal cases, the children received more hydrocodone than recommended for their age.
- At this time, the evidence available in the side effect reports of hydrocodone does not present enough information to conclude that the rate in which it is broken down (metabolized) causes breathing difficulties as is the case for codeine.
Conclusions and actions
- The majority of cases of serious breathing problems identified in the safety review involved children under 6 years of age and usually involving higher-than-recommended doses.
- Health Canada will work with manufacturers to update the product information for hydrocodone to inform that its use in children under 6 years of age is no longer recommended. Health Canada will also issue an Information Update regarding the risk of serious breathing problems.
- Health Canada will continue to monitor side effect information involving hydrocodone, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.
Additional information
The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.
For additional information, contact the Marketed Health Products Directorate.
Footnotes
- Canadian reports can be accessed through the Canada Vigilance Online Database.