Summary Safety Review - Propofol-containing products - Assessing the potential risk of prolonged erection of the penis (priapism)
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: 2019-07-12
Product
Propofol-containing products
Potential Safety Issue
Prolonged erection of the penis (priapism)
Overview
Use in Canada
- Propofol-containing products are prescription drugs which are authorized for sale in Canada and used by health care professionals to make a patient (adult or child) relaxed, calm or sleepy (sedation) or unconscious (anesthesia) during surgery or medical procedures.
- Propofol-containing products have been marketed in Canada since 1993 under the brand name Diprivan. Generic versions of propofol are also available. Propofol is available as a 10 mg/mL solution for injection.
Safety Review Findings
- At the time of the review, Health Canada had received 1 unique Canadian reporta of priapism related to the use of propofol-containing products. A review of this report found a possible link between propofol-containing products and priapism.
- This safety review also looked at 10 international published reports. The link between propofol-containing products and priapism was likely in 2 reports and possible in 7 reports. In 1 report, the priapism was found unlikely to be caused by propofol-containing products.
- In the majority of the reports (9/11), priapism happened between 5 minutes to 2 hours after propofol was administered.
- Most patients (10/11) recovered after treatment of the priapism with only 1 reporting long-term disability (ongoing erectile dysfunction).
Conclusions and actions
- Health Canada's review found that there may be a link between propofol-containing products and the risk of priapism.
- Health Canada has already approved the addition of the risk of priapism to the Canadian product information for Diprivan 1%. Health Canada will notify the manufacturers of other propofol-containing products to update the Canadian product safety information to inform Canadians and health care professionals about this potential safety issue.
- Health Canada will continue to monitor safety information involving propofol-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 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 these drugs both in Canada and internationally.
For additional information about Health Canada's safety review, please contact the Marketed Health Products Directorate.
If manufacturers or industry associations require more information at this time, they are encouraged to contact the Therapeutic Products Directorate (hc.tpdgeneral-generaldpt.sc@canada.ca).
Footnotes
- Canadian reports can be accessed through the Canada Vigilance Online Database.