Summary Safety Review - Hydrocodone-containing products - Assessing the Risk of Serious Breathing Problems (respiratory depression) in Children and Adolescents

July 28, 2016

Product

Hydrocodone-containing products

Potential Safety Issue

Serious breathing problems (respiratory depression) in children and adolescents

Key Messages

  • Hydrocodone is an opioid prescription drug used to treat exhausting, dry (non-productive) cough.
  • Following a safety review by Health Canada looking at codeine use and the risk of serious breathing problems in children, it was decided that a similar review should be carried out for hydrocodone.
  • This safety review identified cases of serious breathing problems with hydrocodone mainly when used in children under 6 years of age.  Health Canada will work with manufacturers to update the product information for hydrocodone so that it is no longer recommended for use in this age group.

Overview

It is known that hydrocodone can slow breathing when too much is taken. The labelling for these drugs already warns of this risk and it applies to all ages, including children. Health Canada’s safety review activities on hydrocodone further studied the risk of serious breathing problems in children and adolescents and stems from review work with codeine (another opioid drug) to determine if more safety measures were needed.

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 overdose Footnote 1. 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.

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