Summary Safety Review - Bortezomib (VELCADE and generics) - Assessing the Potential Risk of Flesh-Eating Disease (Necrotizing Fasciitis) - UPDATE

August 26, 2016

Product

Bortezomib (Velcade and generics)

Potential Safety Issue

Flesh-eating disease (necrotizing fasciitis)

Key Messages

  • Bortezomib (Velcade and generics) is used to treat cancers of the bone marrow (multiple myeloma) and of the lymphatic system (mantle cell lymphoma) affecting the white blood cells.
  • A summary safety review was published on September 3, 2015, following Health Canada’s assessment of a possible link between treatment with bortezomib and flesh-eating disease. That safety review recommended that Health Canada continue to monitor bortezomib for the risk of flesh-eating disease and request additional safety information from the manufacturer.
  • In a follow-up safety review, Health Canada assessed the additional safety information received from the manufacturer. At the time of the updated review, there was insufficient evidence to make a link between bortezomib treatment and the risk of flesh-eating disease. Health Canada will continue to monitor this issue.

Overview

This safety review was done as a follow-up assessment on the possible risk of flesh-eating disease with the use of bortezomib. Health Canada originally published a summary of that safety review on September 3, 2015 At that time, insufficient data was available to make a conclusion about this possible risk. Health Canada asked for additional safety information from the manufacturer and has now completed a follow-up safety review, looking at the new safety information received.

Use in Canada

  • Velcade (bortezomib) has been marketed in Canada since February 2005. It is a chemotherapy medicine, used to kill cancer cells.
  • 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.

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