Summary Safety Review - Ibuprofen- Assessing the Potential Risk of Serious Infection of the Deep Layers of the Skin (Necrotising Fasciitis) in Children with Chickenpox Infection

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: 2020-05-29

Product

Ibuprofen containing-products used in children

Potential Safety Issue

Risk of a rare but very serious infection of the deep layers of the skin (necrotising fasciitis) in children with chickenpox infection

Key Messages

  • Most ibuprofen-containing products are authorized for sale in Canada as non-prescription drugs to treat fever, reduce pain, and relieve inflammation in adults and children. Some ibuprofen-containing products1 are only available by prescription.
  • This review was triggered by a published international case2 of necrotising fasciitis in a child with a chickenpox infection linked with ibuprofen use.
  • Health Canada's review of the available information did not find a link between the use of ibuprofen and the risk of necrotising fasciitis in children with chickenpox infection.
  • Health Canada will continue to monitor the safety of ibuprofen.

Overview

Health Canada reviewed the potential risk of necrotising fasciitis in children treated with ibuprofen during a chickenpox infection. The review only focused on non-prescription ibuprofen-containing products since most ibuprofen products used in children are authorized for sale in Canada as non-prescription drugs. Prescription ibuprofen products1, which contain higher doses of ibuprofen, should not be used in children younger than 12 years of age.

This safety review was triggered by a published case of a 4-year-old girl with a chickenpox infection who started showing symptoms of necrotising fasciitis after the use of ibuprofen. Necrotising fasciitis is also known as flesh-eating disease, a rare infection of the deep layers of the skin that spreads quickly in the body and can lead to death. The symptoms of necrotising fasciitis include a red, warm, or swollen area of skin, severe pain, and fever.

Use in Canada

  • Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) used to treat pain, reduce fever, and relieve inflammation in adults and children. Most ibuprofen products are authorized for sale in Canada as non-prescription drugs.
  • Ibuprofen has been marketed in Canada since 1972, alone or in combination with other drugs.
  • There were around 5 billion (5,177,133,500) units of single ingredient ibuprofen products sold in Canada between October 2006 through September 2018.

Safety Review Findings

  • Health Canada reviewed the available information from published clinical studies as well as suspected cases of necrotising fasciitis reported in the Canada Vigilance database3 and international databases.
  • During the review, Health Canada noticed that health authorities in France and New Zealand added cautionary risk statements in the safety information of children's non-prescription ibuprofen products in order to reduce the risk of necrotising fasciitis in children with chicken pox infection.
  • The literature case report that triggered the Health Canada's review involved a 4-year-old healthy girl with chicken pox who started showing symptoms of necrotising fasciitis after the use of ibuprofen. She was given two doses of ibuprofen before the emergency room visit where she was diagnosed with necrotising fasciitis. The girl was hospitalized and treated with antibiotics and required multiple operations (surgical procedures). Although the case report indicates that ibuprofen did not cause necrotising fasciitis in the patient it recommends avoiding or using ibuprofen carefully in children with chicken pox.
  • The international published studies, which suspected a possible link between the risk of necrotising fasciitis and use of ibuprofen in children with chickenpox, had several limitations including lack of detailed information on whether the patient was already suffering from necrotising fasciitis when ibuprofen was given to relieve symptoms. The review of these studies did not find sufficient evidence for an increased risk of necrotising fasciitis with the use of ibuprofen in children with a chickenpox infection.
  • At the time of the review, Health Canada reviewed 27 international unique case reports of necrotising fasciitis in children with chickenpox who used ibuprofen. Of the 27 cases, 7 cases of necrotising fasciitis were found to be possibly linked with the use of ibuprofen in children with chickenpox, 6 cases of necrotising fasciitis were found to be unlikely to be linked, and the remaining 14 cases of necrotising fasciitis did not have enough information to indicate a conclusive link between necrotising fasciitis and the use of ibuprofen in children with chickenpox. To date, no Canadian cases of necrotising fasciitis in children with chickenpox who used ibuprofen have been reported to Health Canada.
  • The Canadian product monograph for ibuprofen products provides the following risk information which may help to mitigate the potential risk:
    • Warning that ibuprofen may mask the usual signs and symptoms of any infection.
    • Advice to talk to a doctor if the child does not get relief from pain or fever within 24 hours or if redness or swelling is present in the painful area.

Conclusions and actions

  • Health Canada's review of the available information did not find a link between the use of ibuprofen and the risk of necrotising fasciitis in children with a chickenpox infection.
  • Health Canada encourages consumers and health care professionals to report any side effects related to the use of ibuprofen.
  • Health Canada will continue to monitor the safety of ibuprofen, 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 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 information and what is currently known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

References

  1. Prescription Drug List, Government of Canada, Health Canada, Health Products
  2. Darmasseelane K, Banks T, Rjabova T. 2018. Necrotising fasciitis as a complication of primary varicella infection in an immunocompetent child. BMJ Case Rep 2018. doi:10.1136/bcr-2018-225018.
  3. Canadian reports can be accessed through the Canada Vigilance Online Database.

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