Summary Safety Review - Tumour Necrosis Factor (TNF) alpha blockers (SIMPONI and CIMZIA) - Assessing the Potential Risk of Liver Inflammation (Autoimmune Hepatitis)
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: 2016-10-25
Product
Tumour necrosis factor (TNF) alpha blockers (Simponi and Cimzia)
Potential Safety Issue
Inflammation of the liver (Autoimmune Hepatitis)
Overview
Use in Canada
- TNF alpha blockers are immune system proteins (monoclonal antibodies) that block a specific protein (TNF alpha), resulting in a decrease of inflammation.
- At the time of this review, five TNF alpha blockers were marketed in Canada:
- Enbrel (etanercept): 2001
- Remicade (infliximab): 2001
- Humira (adalimumab): 2004
- Cimzia (certolizumab pegol): 2009
- Simponi (golimmab): 2009
Safety Review Findings
- At the time of this review, 5 serious cases of liver inflammation were reported with Cimzia, of which 1 case was reported in the Canada Vigilance database. There were no cases of liver inflammation reported with the use of Simponi.
- Of these 5 cases reported with Cimzia, the Canadian case and 2 non-Canadian cases were assessed as potentially linked to Cimzia. These 3 patients improved when they stopped using Cimzia.
- For the remaining 2 cases, there was either not enough information to establish a link to Cimzia or there were other possible explanations for the liver inflammation.
Conclusions and actions
- Health Canada's review found a possible link between the risk of liver inflammation and the use of TNF alpha blockers.
- Following the completion of this safety review, the manufacturers of Cimzia and Simponi have updated the Canadian product information to include the risk of liver inflammation (autoimmune hepatitis).
- Health Canada will continue to monitor adverse reaction information involving TNF alpha blockers, 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.