Health Canada safety review finds possible link between Fibristal and risk of liver injury

Issue

OTTAWA – Health Canada is informing Canadians that its safety review of Fibristal (ulipristal acetate) found a possible link between its use and the risk of a rare but serious liver injury.

Fibristal is approved in Canada to treat signs and symptoms of a type of non-cancerous tumour in the uterus (fibroids) in women of childbearing age.

The department initiated its safety review after receiving four international reports of liver injury leading to liver transplants.

To support the safe use of this medication, Health Canada has worked with the manufacturer to update the Canadian product safety information for Fibristal.

The product safety information updates include new restrictions for use. In particular, Fibristal should not be used in women who currently have, or have previously had liver problems. Intermittent use (more than one treatment course) should be   restricted to women of childbearing age who are not eligible for surgery to remove their fibroids. In addition, the product safety information has been updated to include requirements for liver function monitoring before, during and after treatment.

Health Canada will continue to monitor the use of Fibristal and will take action if new safety risks are identified.

What you should do

Important safety information for patients:

  • Inform your healthcare provider if you currently have or have previously had liver problems, or if you have any doubts about the condition of your liver.
  • Be aware that your healthcare provider will do blood tests before, during and after treatment with Fibristal to assess your liver function.
  • Stop treatment and contact your healthcare provider immediately if you develop symptoms of liver injury (such as tiredness, yellowing of the skin, darkening of the urine, or nausea and vomiting).
  • If you are using Fibristal and have concerns, talk to your healthcare provider or pharmacist.

Important information for healthcare providers:

  • Do not prescribe Fibristal to patients who currently have or have previously had liver problems.
  • Inform your patient about the risk of a rare but serious liver injury associated with  the use of Fibristal and the need for monitoring their liver function before, during and after treatment.
  • Inform your patient about the signs and symptoms of liver injury and the need to stop Fibristal treatment and consult a physician should they occur.

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public enquiries

(613) 957-2991
1-866 225-0709

For more information

For more information, please review the Canadian Product Monograph for Fibristal.

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