Summary Safety Review - Cisplatin - Assessing the Potential Risk of Blood Clots in the Veins (venous thromboembolism)
February 12, 2016
Potential Safety Issue
Blood clots in the veins (venous thromboembolism)
Cisplatin, in combination with other treatments, is used to treat advanced bladder, testicular and ovarian cancers.
This safety review was triggered when Health Canada identified a possible risk of blood clots in the veins (venous thromboembolism) with cisplatin treatment, during the routine review of updated prescribing information published by a foreign regulatory agency (Japan).
Health Canada’s review concluded that cisplatin is linked to a higher risk of venous thromboembolism when used to treat patients with advanced bladder, testicular and ovarian cancers. Health Canada has therefore asked manufacturers of cisplatin products to update their prescribing information to include warnings about this increased risk.
Health Canada carried out a safety review to look into the potential increased risk of venous thromboembolism with the use of cisplatinFootnote 1. This issue was found during a routine review of new safety information published by a foreign regulatory agency (Japan)Footnote 2.
Use in Canada
Cisplatin, in combination with other treatments, is used to treat patients with some forms of advanced bladder, testicular and ovarian cancers.
Cisplatin has been sold in Canada since 1979. It is available by prescription only.
There are 5 generic cisplatin products on the Canadian market, sold as intravenous injections in a 1 mg/mL strength, in 10 mL, 50 mL and 100 mL sizes.
Safety Review Findings
At the time of the review, Health Canada had received 18 reports of venous thromboembolism with the use of cisplatin. All cases were determined to be possibly related to the drug. Among the reported cases, 5 had a reported fatal outcome, but no conclusions could be made regarding the cause of death based on the information provided in the adverse event reports. Cancer patients have a higher risk of venous thromboembolism and related fatal complications.
The World Health Organization’s database had 520 cases of venous thromboembolism linked with cisplatin at the time of this review.
A published studyFootnote 3 looked at how often venous thromboembolism occurs in patients receiving cancer treatment. It concluded that there is a greater risk of venous thromboembolism with cisplatin treatment, compared to non-cisplatin treatment, when used in patients with solid tumours.
Conclusions and Actions
Health Canada’s safety review considers that there is an increased risk of venous thromboembolism with the use of cisplatin in the treatment of advanced bladder, testicular and ovarian cancers.
Health Canada has recommended that the prescribing information for cisplatin products be updated by all manufacturers of cisplatin in Canada to include warnings about the increased risk of venous thromboembolism.
Health Canada will continue to monitor side effect information involving cisplatin, 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.
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.
For additional information, contact the Marketed Health Products Directorate.
Report a problem or mistake on this page
- Date modified: