Summary Safety Review - Bortezomib (VELCADE and generics) - Assessing the Potential Risk of Flesh-Eating Disease (Necrotizing Fasciitis) - UPDATE
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: 2016-08-26
Product
Bortezomib (Velcade and generics)
Potential Safety Issue
Flesh-eating disease (necrotizing fasciitis)
Overview
Use in Canada
- VELCADE (bortezomib) is used to treat cancers of the bone marrow (multiple myeloma) and the lymphatic system that affects white blood cells (mantle cell lymphoma).
- Bortezomib is used for the treatment of adult patients who have cancers of the bone marrow called Multiple Myeloma (MM) or of the blood called Mantle Cell Lymphoma (MCL) affecting the white blood cells.
- The number of Canadian prescriptions for bortezomib is relatively low (about 5000 prescriptions per year). Bortezomib is mostly used in hospitals.
Safety Review Findings
- At the time of the updated review, which was based on the safety information received from the manufacturer, there were no cases of flesh-eating disease linked with the use of bortezomib in Canada.
- A search of the manufacturer's safety database for Velcade (bortezomib) found 11 international cases of flesh-eating disease. Health Canada reviewed these international cases and found that 8 cases were possibly linked and 3 cases were unlikely to be linked to the use of bortezomib. All 11 cases may have been impacted by the use of other medicines at the same time as bortezomib (concomitant medications), underlying diseases or other risk factors which could also have played a role in the development of flesh-eating disease.
- Risk factors for flesh-eating disease include diabetes, alcohol use, smoking, obesity, the decrease of a body's ability to fight a disease (immune suppression), chronic steroid use, and blood circulation diseases affecting blood vessels (peripheral vascular disease). In addition, transplant and cancer patients are more likely to get infections in general, including being infected by germs that cause flesh-eating disease, due to their weakened immune system.
Conclusions and actions
- Health Canada's follow-up safety review concluded that there was insufficient evidence at this time to make a link between bortezomib and flesh-eating disease.
- Health Canada will continue to monitor side effect information for bortezomib (Velcade and generics), as it does for all health products on the Canadian market, to identify and assess possible 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.