Summary Safety Review - VOTRIENT (pazopanib) - Assessing the Potential Risk of Accumulation of Fluid Around the Heart (Pericardial Effusion)

November 30, 2015

Product

Votrient (pazopanib)

Potential Safety Issue

Accumulation of fluid around the heart (pericardial effusion)

Key Messages

  • Votrient (pazopanib) is a drug used to treat metastatic kidney and advanced soft tissue cancers.
  • Health Canada’s safety review on the possible accumulation of fluid around the heart (pericardial effusion) with Votrient use was triggered by an article in The World Health Organization (WHO) Pharmaceutical Newsletter which presented cases of this issue.
  • The current safety review did not find enough information to support a link between the risk of pericardial effusion and the use of Votrient. Health Canada has requested the manufacturer to continue to provide information on this safety issue and will continue to monitor this potential risk.

Overview

A safety review was done to evaluate the potential risk of accumulation of fluid around the heart (pericardial effusion) in patients taking the anti-cancer drug Votrient (pazopanib). Pericardial effusion is a serious condition which can cause heart problems or lead to death. The safety review was triggered by an article in the World Health Organization (WHO) Pharmaceutical Newsletter which presented cases of this issue.

Use in Canada

  • Votrient is an anti-cancer drug (a tyrosine kinase inhibitor).
  • Votrient is used to treat two rare and advanced types of cancers: metastatic kidney cancer and advanced soft tissue cancer. Metastatic kidney cancer (metastatic renal cell carcinoma) is a type of kidney cancer where cancer cells have spread from the kidney to other parts of the body. Advanced soft tissue cancer (soft tissue sarcoma) is a type of cancer that occurs in soft tissues like fat, muscle, tendon, nerves, blood vessels, etc.
  • Although not commonly prescribed, Votrient use has been steadily increasing since its marketing in Canada in August 2010.

Safety Review Findings

  • At the time of the review, no cases of pericardial effusion linked with pazopanib were reported in Canadaa.
  • Health Canada’s review of the reported cases received from the manufacturer and /or found in the literature was limited in its ability to confirm and assess the potential role of Votrient and the risk of pericardial effusion based on factors such as the progression of the cancer.
  • Limited information was found during the review of scientific literature on pericardial effusion with Votrient use.

Conclusions and Actions

  • The safety review found limited evidence to support an increased risk of pericardial effusion with the use of the anti-cancer drug Votrient.
  • Health Canada has asked the manufacturer to continue to provide information on this safety issue.
  • Health Canada will continue to monitor side effect information involving Votrient, 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 adverse reaction reports, and what is known about the use of this drug and their risks both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

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