Summary Safety Review - TECFIDERA (Dimethyl Fumarate) - Serious allergic reactions including skin reactions and anaphylaxis
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: 2015-06-26
Product
Tecfidera (Dimethyl Fumarate)
Potential Safety Issue
Serious allergic reactions including skin reactions and anaphylaxis
Overview
Use in Canada
- TECFIDERA is used to treat multiple sclerosis, a debilitating disease in which the immune system attacks the protective cover (myelin) of the nerves to disrupt communication between the brain and spinal cord with the rest of the body. Currently, there is no cure for multiple sclerosis.
- TECFIDERA helps to reduce the number of flare-ups (relapses) that occur and slows the progression of physical disability. It works by changing the way the body's immune system functions, helping to keep it from further damaging the brain and the spinal cord.
- TECFIDERA was first marketed in Canada on April 12, 2013.
Safety Review Findings
- At the time of this review, Health Canada considered the evidence provided in both domestic and international reports, including those provided by the product manufacturer, of hypersensitivity associated with TECFIDERA.
- Up until June 30, 2014, the Canada Vigilance Program received 9 Canadian reports of hypersensitivity associated with TECFIDERA.a Of these cases, 4 were possibly or likely associated with TECFIDERA.
- Five international cases, which reported life-threatening anaphylactic events, were possibly or likely associated with TECFIDERA.
- Overall, the number of hypersensitivity reactions has been increasing for TECFIDERA with some reports being life-threatening. This increase may be due to a greater use of TECFIDERA.
Conclusions and actions
- Health Canada concluded that the overall benefits of TECFIDERA continue to outweigh the risks when used as recommended.
- The Canadian prescribing information for TECFIDERA was updated to inform prescribers and patients of hypersensitivity reactions, including angioedema and anaphylaxis.
- During the safety review by Health Canada, the Canadian prescribing information was also updated to mention that the possibility of hypersensitivity or anaphylactic reactions should be considered in patients experiencing severe flushing reactions (e.g. flushing, hot flushes, warmth, redness, itching, and/or burning sensations). These symptoms may present similarities with hypersensitivity reactions.
- Health Canada will continue to monitor adverse reaction information involving TECFIDERA, 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 information on this risk is 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
- Canadian reports can be accessed through the Canada Vigilance Adverse Reaction Database.