Summary Safety Review - Carboplatin-containing products - Assessing the Potential Risk of Posterior Reversible Encephalopathy Syndrome

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: 2020-12-16

Product

Carboplatin-containing products

Potential Safety Issue

Posterior Reversible Encephalopathy Syndrome (PRES), a rare and serious brain condition

Key Messages

  • Carboplatin-containing products are authorized for sale in Canada to treat ovarian cancer.
  • Health Canada reviewed the risk of Posterior Reversible Encephalopathy Syndrome (PRES) with the use of carboplatin-containing products. The review was triggered by a safety labelling update for carboplatin-containing products related to this risk in New Zealand.
  • Health Canada's review concluded that there may be a link between the use of carboplatin-containing products and the risk of PRES.
  • Health Canada will work with the manufacturers of carboplatin-containing products to update the Canadian product safety information to include the risk of PRES.

Overview

Health Canada reviewed the potential risk of Posterior Reversible Encephalopathy Syndrome (PRES) with carboplatin-containing products following a safety labelling update for PRES and these products in New Zealand.

PRES is a rare and serious brain condition, which can include headaches, seizures, visual problems, nausea and vomiting. This condition is also known as Reversible Posterior Leukoencephalopathy Syndrome.

Use in Canada

  • Carboplatin-containing products are prescription drugs that are authorized for sale in Canada to treat ovarian cancer.
  • Carboplatin was first marketed in Canada in 1986 under the brand name Paraplatin (no longer marketed). Generic versions of carboplatin are still available in Canada. Carboplatin-containing products are available as 10 mg/mL sterile solutions for injection.

Safety Review Findings

  • Health Canada reviewed information from searches of the Canada Vigilance databasea and scientific and medical literature.
  • At the time of the review, Health Canada had not received any Canadian reports of PRES related to carboplatin use.
  • Health Canada's review focused on 19 international case reports of PRES with the use of carboplatin-containing products (16 of them published in the medical literature).
  • Health Canada concluded that a link between carboplatin use and PRES was possible in all 19 case reports.
  • In all 19 cases, other factors that are known to be associated with PRES were present, such as the patients' general poor health, and several chemotherapy drugs given to the patients at the same time.

Conclusions and actions

  • Health Canada's review of the available information concluded that there may be a link between the use of carboplatin-containing products and the risk of PRES.
  • Health Canada will work with manufacturers to update the Canadian product safety information for carboplatin-containing products to include the risk of PRES.
  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of carboplatin and other health products to the Canada Vigilance Program.
  • Health Canada will continue to monitor safety information involving carboplatin-containing products, 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 should new health risks be identified.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, international information, and what is known about the use of carboplatin 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 Online Database.