Summary Safety Review - REMICADE (infliximab) - Assessing the potential risk of a blistering skin condition known as linear IgA bullous dermatosis

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: 2018-07-23

Product

Remicade (infliximab)

Potential Safety Issue

Blistering skin condition known as linear IgA bullous dermatosis

Key Messages

  • Remicade is authorized for sale in Canada to treat adults and children with inflammation of the skin (psoriasis), joints (rheumatoid or psoriatic arthritis), and intestines (Crohn's disease and ulcerative colitis) that result from an imbalance of the body's defense system (autoimmune disease).
  • Health Canada reviewed the potential risk of a blistering skin condition known as linear IgA bullous dermatosis with the use of Remicade, following published reports of this risk in patients treated with Remicade.
  • Health Canada's review of the available information concluded that there may be a link between the use of Remicade and the risk of linear IgA bullous dermatosis. Health Canada has worked with the manufacturer of Remicade to update the product safety information to include the risk of this blistering skin condition.

Overview

Remicade is a prescription drug used to treat adults and children with inflammation of the skin (psoriasis), joints (rheumatoid or psoriatic arthritis) and intestines (Crohn's disease and ulcerative colitis) caused by an imbalance of the body's own defense system (autoimmune disease).

Remicade is an immune system protein (antibody), which blocks a naturally occurring chemical known as TNF-α (Tumour Necrosis Factor-alpha) that causes inflammation in the body.

Health Canada reviewed the potential risk of a blistering skin condition known as linear IgA bullous dermatosis with the use of Remicade, following published reports of this risk in patients treated with Remicade.

Use in Canada

  • Remicade is a prescription drug authorized for sale in Canada. It has been marketed in Canada since 2001.

Safety Review Findings

  • At the time of the review, Health Canada had received 1 Canadian reporta of a blistering skin condition in a patient treated with Remicade. This report showed that there was a potential link between the use of Remicade and the blistering skin condition.
  • The safety review also looked at information from 6 case reports (including the Canadian report) provided by the manufacturer of Remicade. It was determined that, in 4 of these cases, the blistering skin disease was potentially related to the Remicade treatment, while the remaining 2 cases could not be assessed due to missing information.
  • Review of data from these cases and the scientific literature supported a possible link between the use of Remicade and the risk of the blistering skin condition.
  • Since the blistering skin condition has only been reported in a small number of patients using Remicade, it was concluded that the risk of it happening with the use of the drug is rare.
  • The European Medicines Agency has updated the product safety information for Remicade to include the risk of this blistering skin condition. Product safety information in the United States does not contain any information specific to this blistering skin condition.

Conclusions and actions

  • Health Canada's review of the available information concluded that there may be a link between the use of Remicade and the risk of the blistering skin condition.
  • Health Canada has worked with the manufacturer of Remicade to update the product safety information to include the risk of this blistering skin condition.
  • Health Canada will continue to monitor safety information involving Remicade, 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

  1. The Canadian report can be accessed through the Canada Vigilance Online Database.

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