Summary Safety Review - AVASTIN (bevacizumab) - Assessing the Potential Risk of Irreversible Vocal Cord Damage (vocal cord necrosis)

November 30, 2015

Product

Avastin (bevacizumab)

Potential Safety Issue

Irreversible vocal cord damage (vocal cord necrosis)

Key Messages

  • In Canada, Avastin is used alone or with other drugs to treat cancers of the large bowel, lung or brain.
  • During routine monitoring, Health Canada identified a report linking the use of Avastin to irreversible vocal cord damage (vocal cord necrosis). A safety review was done to further examine this potential issue.
  • At the time of the review, Health Canada did not find enough evidence to link Avastin treatment with vocal cord necrosis. Health Canada will continue to monitor for information about this safety issue.

Overview

During routine monitoring, Health Canada identified a report of a woman who suffered from hoarseness due to vocal cord necrosis after using Avastin with another anti-cancer drug. As a result of this report, Health Canada undertook a review of this potential safety issue.

Use in Canada

  • Avastin, when given in combination with other anti-cancer drugs, is used to treat patients with a specific type of lung cancer or patients with large bowel cancer that has spread.
  • By itself, Avastin is used to treat patients with a specific type of aggressive brain cancer who have not improved enough with other treatments.
  • Avastin has been sold in Canada since November 2005.

Safety Review Findings

  • There were no reports of vocal cord necrosis in patients using Avastin in Canada at the time of the review.
  • Internationally, from 2000 to 2014, there were 14 reports of side effects affecting the vocal cords with 3 reports of vocal cord necrosis.
  • Out of 26,420 patients in international clinical studies with Avastin, 11 reported possible vocal cord necrosis but the cause was not confirmed.
  • An assessment of scientific and medical literature at the time of the review identified 16 international cases of damage to the vocal cords, 3 of which were confirmed cases of irreversible damage. There was incomplete information to confirm the other 13 cases.

Conclusions and Actions

  • Health Canada’s review found that there is not enough evidence to link Avastin treatment with an increased risk of vocal cord necrosis.
  • The actual frequency of vocal cord necrosis in patients using Avastin is unknown because for most cases of side-effects to the vocal cords, procedures to confirm the exact condition were not performed.
  • A very small number (0.04%) of patients enrolled in clinical studies with Avastin had symptoms of vocal cord necrosis that may have potentially been related to use of Avastin.
  • Health Canada will continue to monitor side effect information involving Avastin, as it does for all health products on the Canadian market, to identify and assess potential harms. Heath Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that was carried out for this safety review took into consideration information from scientific and medical literature, Canadian and international adverse reaction reports as well as what is known about the use of this drug in Canada and internationally.

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