Summary Safety Review - Bortezomib (VELCADE and Generics) - Assessing a Potential Link with Flesh-Eating Disease (Necrotising Fasciitis)

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: 2015-09-03

Product

Bortezomib (VELCADE and generics)

Potential Safety Issue

Assessing a potential link between bortezomib treatment and flesh-eating disease (necrotising fasciitis)

Key Messages

  • VELCADE (bortezomib) is used to treat cancers of the bone marrow (multiple myeloma) and the lymphatic system that affects the white blood cells (mantle cell lymphoma).
  • This safety review was triggered by two published articles. These two articles described the potential association between treatment with bortezomib and flesh-eating disease (necrotising fasciitis), a rare infection of the deeper layers of skin and underlying tissues.
  • At this time, there is limited evidence to make an association between bortezomib treatment and the risk of flesh-eating disease. Health Canada has requested additional safety information from the manufacturer to review and will continue to monitor VELCADE for the risk of flesh-eating disease.

Overview

A safety review was done to assess the potential association between flesh-eating disease and VELCADE (bortezomib). This issue was identified through a Health Canada review of safety information found in two published articles that described medical case reports of flesh-eating disease in two patients treated with bortezomib1,2

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).
  • As of June 2015, less than 5,000 prescriptions have been issued each year in Canada. Bortezomib is mostly used in hospitalsa.

Safety Review Findings

  • At the time of the review, no cases of flesh-eating disease in association with bortezomib were reported in Canadab while 11 cases were reported in Europec.
  • A review of the scientific and medical literature identified two additional medical case reports relevant to the topic of flesh-eating disease linked with the use of bortezomib.
  • All reported cases reviewed by Health Canada may have been impacted by the use of two medications at the same time (co-medication: bortezomib and another medication) or other risk factors. The risk factors seen in these cases were diabetes, alcohol use, smoking and obesity, the decrease of a body's ability to fight a disease (immune suppression), chronic steroid use and blood circulation diseases affecting blood vessels. As such, these factors make it difficult to link the use of bortezomib alone and flesh-eating disease, at this time.

Conclusions and actions

  • At this time, the safety review found limited evidence to make a link between VELCADE (bortezomib) use and the risk of flesh-eating disease (necrotising fasciitis).
  • Health Canada has requested additional safety information from the manufacturer to review and will continue to monitor VELCADE (bortezomib) for the risk of flesh-eating disease.

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.

References

  1. Morita T, Ugai T, Tanimoto T, Matsue K. Necrotising fasciitis after bortezomib and dexamethasone-containing regimen in an elderly patient of Waldenstrom macroglobulinaemia. BMJ Case Reports. 26 Mar 2014;No. 203399.
  2. Rosser A, Swallow G, Swann RA, Chapman C. Salmonella enteritidis necrotising fasciitis in a multiple myeloma patient receiving bortezomib. Int J Hematol. 2010 Jan;91(1):149-5

Footnotes

  1. IMS utilization data provided by: IMS Health Canada Inc. An external party cannot refer to nor use IMS data, which have been generated by Health Canada, without a Third Party Agreement in place.
  2. Canadian reports can be accessed through the Canada Vigilance Online Database
  3. Eudravigilance can be accessed through the Eudravigilance Online Database

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