Summary Safety Review - ENBREL (etanercept) - Schizophrenia like symptoms

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: 2015-08-26

Product

ENBREL (etanercept)

Potential Safety Issue

Schizophrenia like symptoms

Key Messages

  • ENBREL is used to treat inflammation of joints and skin caused by the body's own defence system attacking its joints and skin, including certain forms of arthritis and psoriasis.
  • Health Canada conducted a safety review after a report linking the use of ENBREL to the occurrence of symptoms resembling a form of mental illness (schizophrenia) was published in a scientific journal.
  • The review did not find enough information to support an association between symptoms resembling schizophrenia and the use of ENBREL. Health Canada will continue to monitor this issue.

Overview

Health Canada conducted a safety review to evaluate harmful effects (adverse reactions) related to symptoms resembling schizophrenia linked to the use of ENBREL. The safety review was triggered by a published case of a 54-year old woman taking ENBREL who developed symptoms similar to schizophrenia1. Symptoms of schizophrenia include disorganized thinking and speech, hearing or seeing things that are not there (hallucinations), suspiciousness, and false beliefs (delusions).

Use in Canada

  • ENBREL is an immune system protein (monoclonal antibody) which works by blocking a chemical TNF-α (Tumour Necrosis Factor-alpha) that causes pain and swelling (inflammation).
  • This medicine treats inflammation that results from the body's own defence system attacking its joints and skin (autoimmune diseases). Examples of autoimmune joint and skin diseases include ankylosing spondylitis, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, and plaque psoriasis.
  • ENBREL is given through an injection under the skin and is available by prescription only.
  • ENBREL has been marketed in Canada since March 14, 2001.

Safety Review Findings

  • At the time of the review, 25 cases of mental health disorders (psychiatric disorders), including two cases where the patients were unable to recognize reality or relate to others (psychosis), were received through the Canada Vigilance Programa. No case of schizophrenia was reported. When Health Canada studied these 25 cases, no link between schizophrenia and the use of ENBREL was shown.
  • A review of international data from the World Health Organization's database retrieved 209 cases of psychiatric disorders, including anxiety, depression, and psychosis. However, Health Canada's evaluation of the cases did not indicate that schizophrenia was linked to the use of ENBREL.
  • Confirming and assessing these Canadian and international reports of psychiatric disorders was limited by many factors because the information in some reports was incomplete, patients had other diseases or a past history of psychiatric disorders, or patients were taking other medications at the same time as ENBREL.
  • The risks of anxiety and depression are already included in the Canadian prescribing information for ENBREL.

Conclusions and actions

  • The current safety review by Health Canada does not support a link between a schizophrenia-like disorder and the use of ENBREL.
  • The risks of anxiety and depression are already included in the Canadian prescribing information for ENBREL.
  • Health Canada will continue to monitor adverse reaction information involving ENBREL, as it does with all health products on the Canadian market, to find and study potential harms. Health Canada will take appropriate and timely action, as appropriate, if and when any new health risks are identified.

Additional information

The analysis that was carried out for this safety review took into consideration information from scientific and medical literature, Canadian and international adverse reaction reports as well as what is known about the use of this drug in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

References

  1. Atigari OV, Healy D. Schizophrenia-like disorder associated with etanercept treatment. BMJ Case Rep. January 13, 2014.

Footnotes

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

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