Summary Safety Review - FERAHEME (ferumoxytol) - Serious allergic reactions (Hypersensitivity reactions)
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: 2015-07-03
Product
FERAHEME (ferumoxytol)
Potential Safety Issue
Serious allergic reactions (Hypersensitivity reactions)
Overview
Use in Canada
- FERAHEME is an injectable iron product used to treat low levels of iron in the blood (iron deficiency anemia) in adults with chronic kidney disease.
- It was first marketed in Canada in May 2012.
Safety Review Findings
- The risk of serious, potentially fatal, hypersensitivity reactions is known for FERAHEME and other injectable iron products.
- As of February 28, 2014, there were more than 20 Canadian reports of serious hypersensitivity reactions, including 2 deaths, received through the Canada Vigilance Programa. Over half were reported in a 6 month period.
- Many of the international cases of serious or fatal hypersensitivity reactions reported with FERAHEME documented patients as having allergies to other medicines as well.
Conclusions and actions
- Although Health Canada's safety review determined that the Canadian prescribing information for FERAHEME contained warnings about the risk of serious hypersensitivity reactions, when considering the totality of the evidence an update was made to the prescribing information.
- The Canadian prescribing information for FERAHEME has been updated with the limitations for who should not be given FERAHEME and the information about how it should be given to reduce the risk of serious hypersensitivity reactions.
- Health Canada issued a healthcare professional communication and a public communication about new limitations for who should not be given FERAHEME, including patients with allergies to injectable iron products or with multiple drug allergies. Another healthcare professional communication was issued with information on how FERAHEME should be given to reduce the risk of serious hypersensitivity reactions. Additionally, the limitation information was updated to avoid giving FERAHEME to patients with any known history of drug allergy.
- Health Canada will continue to monitor adverse reaction information involving FERAHEME and other injectable iron products, 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
- Canadian reports can be accessed through the Canada Vigilance Adverse Reaction Database.