Summary Safety Review - NEXAVAR (sorafenib) - Thyroid Gland Dysfunction

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: 2015-05-28

Product

NEXAVAR (sorafenib)

Potential Safety Issue

Thyroid gland dysfunction

Key Messages

  • NEXAVAR (sorafenib) is an anti-cancer drug from the multikinase inhibitor family of drugs used to treat specific types of liver, kidney, and thyroid cancers in adults.
  • A safety review was done after a case of severe hyperthyroidism, called thyroid storm, associated with use of NEXAVAR was reported in a scientific journal. Hyperthyroidism is a type of thyroid gland dysfunction where excessive amounts of thyroid hormones are released into the blood that may cause fast heartbeat, tiredness, weight loss, nervousness and/or trembling.
  • As a result of this safety review, the Canadian prescribing information for NEXAVAR has been updated to inform healthcare professionals, caregivers, and patients about the risks of thyroid gland dysfunction and the need to monitor thyroid function before and during use. The risk of thyroid gland dysfunction is already included in the Canadian prescribing information for other multikinase inhibitors.

Overview

A safety review studied the risk of drug-induced thyroid gland dysfunction associated with NEXAVAR. Thyroid gland dysfunction happens when the levels of the hormones that the thyroid gland makes are too high (hyperthyroidism) or too low (hypothyroidism). Thyroid gland dysfunction can impact metabolism as well as many other functions of the body. The safety review was triggered by a published fatal case of an elderly man who developed thyroid storm three weeks after he began treatment with NEXAVAR. Thyroid storm is a life-threatening form of hyperthyroidism.

Use in Canada

  • NEXAVAR is an anti-cancer drug from the multikinase inhibitor family of drugs used in adults. Although not widely used, it is for the treatment of specific types of relatively rare and advanced cancers, including liver, kidney, and thyroid cancers.
  • NEXAVAR works by blocking the growth and spread of cancer cells.
  • It was first marketed in Canada on July 31, 2006.

Safety Review Findings

  • Thyroid gland dysfunction may occur with NEXAVAR use, including, very rarely, thyroid storm.
  • There were many case reports of thyroid gland dysfunction associated with the use of NEXAVAR in the scientific literature, manufacturer's database and the World Health Organization's database at the time of this safety review. The analysis of the cases showed evidence of thyroid disorders in association with NEXAVAR use. Up until January 31, 2015, there were no Canadian reports of thyroid gland dysfunction received through the Canada Vigilance Program.a
  • Canadian prescribing information for other multikinase inhibitors (e.g. Sunitinib, Pazopanib and Axitinib) already contains information on thyroid dysfunction.

Conclusions and actions

  • Health Canada's safety review showed evidence of thyroid gland disorders in association with NEXAVAR use.
  • As a result of this safety review, Health Canada has updated the Canadian prescribing information for NEXAVAR (sorafenib) to inform healthcare professionals, caregivers, and patients about the risks of thyroid dysfunction. Thyroid function monitoring should be considered before and during NEXAVAR use.
  • Health Canada will publish a safety information update in the May 2015 issue of the Health Product InfoWatch.

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.

Footnotes

  1. Canadian reports can be accessed through the Canada Vigilance Adverse Reaction Database.

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