Summary Safety Review - AVASTIN (bevacizumab) - Assessing the Potential Risk of Damage in Bones other than the Jawbone in Adult Cancer Patients

April 5, 2017

Product

Avastin (bevacizumab)

Potential Safety Issue

Damage in bones other than the jawbone (non-mandibular osteonecrosis) in adult cancer patients

Key Messages

  • Avastin (bevacizumab) is a prescription health product authorized for sale in Canada, when used alone or with chemotherapy to treat certain types of cancer.
  • Health Canada reviewed the risk of damage in bones other than the jawbone (non-mandibular osteonecrosis) in adult cancer patients treated with Avastin (bevacizumab) following the publication of 2 reportsFootnote 1 of this side effect.
  • After reviewing the available data, it was determined that there was not enough information to establish a definitive link between the use of Avastin and the risk of non-mandibular osteonecrosis in adults. However, Health Canada has recommended that the manufacturer update the product safety information to include information on reports of non-mandibular osteonecrosis in adult cancer patients treated with Avastin.

Overview

Health Canada reviewed the risk of damage in bones other than the jawbone (non-mandibular osteonecrosis) in adult cancer patients treated with Avastin (bevacizumab) following the publication of 2 reportsFootnote 1 in the literature of this side effect. Damage in the jawbone (mandibular osteonecrosis) is a known risk and is reflected in details on the Canadian product safety information for Avastin. Therefore, this safety review focused on non-mandibular osteonecrosis. This type of bone damage is serious because it causes severe pain and the affected bone can become deformed or can fracture.

Use in Canada

  • Avastin is a prescription health product authorized for sale in Canada, to treat a certain type of brain cancer (glioblastoma), when used alone. It can also be used with chemotherapy to treat certain types of cancer of the large bowel, lung, female reproductive system and the lining of the abdominal cavity.
  • Avastin has been marketed in Canada since 2005. It is available as a solution for injection.

Safety Review Findings

  • At the time of the review, Health Canada had received 1 Canadian reportFootnote a of non-mandibular osteonecrosis related to Avastin use. In that report, there was not enough information to conclude that Avastin use alone had caused this condition, although a link could not be ruled out.
  • This safety review also looked at information on 67 international reports of non-mandibular osteonecrosis related to the use of Avastin, including the 2 casesFootnote 1 that triggered Health Canada's safety review. In 26 of these reports, a link between Avastin and non-mandibular osteonecrosis could not be definitively ruled out. In the remaining 41 reports, there was either not enough information to establish a link, or there were other factors that could have explained the condition such as other medical conditions of the bones or being on treatments that are known to cause bone damage.

Conclusions and Actions

  • After review of available data, it was determined that there was not enough information to establish a definitive link between the use of Avastin and non-mandibular osteonecrosis in adult cancer patients. However, Health Canada has recommended that the manufacturer update the product safety information to include information of the reports of non-mandibular osteonecrosis in adult cancer patients treated with Avastin. The current Canadian safety information only mentions this risk in children treated with Avastin, not in adults.
  • Health Canada will continue to monitor safety information involving Avastin, 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 information, and what is known about the use of this health product both in Canada and internationally. For additional information, contact the Marketed Health Products Directorate.

For additional information, contact the Marketed Health Products Directorate.

Reference

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