Health Canada reviews safety of drug Fibristal again following new case of liver injury

General Intrests

**** HEALTH CANADA Release

Health Canada reviews safety of drug Fibristal again following new case of liver injury

Health Canada continues to monitor safety information involving Fibristal (ulipristal acetate) as it does for all health products on the Canadian market. The Department is again reviewing the risk of serious liver injury associated with Fibristal, in response to a new international case of liver injury that led to a liver transplantation, and the European Medicines Agency’s recommendation to revoke the marketing authorization of the ulipristal acetate medication called Esmya in Europe.

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

In a 2018 safety review, Health Canada concluded that there may be a link between Fibristal use and risk of serious liver injury. The Department informed Canadians of this risk and directed the manufacturer to implement new safety measures. These measures are to minimize the risks and support the safe use of this medication. The company was also directed to conduct specific studies to look at the effectiveness of these new measures. The measures include:

  • restricting the drug’s use to women with no previous or current liver problems;
  • restricting the use of more than one course of treatment to women who are not eligible for surgery;
  • requiring more frequent liver function tests; and
  • creating a healthcare professional brochure and a patient alert card about the risks of serious liver injury.

As part of its most recent review of the issue, Health Canada consulted with experts, including international health regulators, healthcare practitioners, and the Society of Obstetricians and Gynaecologists of Canada. This review focused on the treatment of uterine fibroids to better understand the use of Fibristal in Canadian clinical practice and determine the importance of this product as a treatment option for women suffering from uterine fibroids.

Health Canada is also evaluating the recommendations from the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee to revoke the marketing authorisation of Esmya for uterine fibroids in Europe, and is working with the Canadian manufacturer of Fibristal to determine the appropriate next steps in Canada.

The Department will continue to update Canadians, including healthcare providers, on this important safety issue.

Information for patients:

  • Inform your healthcare provider if you are taking Fibristal and currently have or have previously had liver problems, or if you have any concerns about possible liver problems.
  • 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 nausea, vomiting, severe tiredness, yellowing of the eyes or skin, dark urine or stomach-ache).
  • Talk to your healthcare provider if you are using Fibristal and have any concerns.

Information for healthcare providers:

As per the Canadian Product Monograph:

  • Do not prescribe Fibristal to patients who currently have or have previously had liver problems.
  • Monitor your patient’s liver function before starting each Fibristal treatment, at least once a month during their treatment and 2–4 weeks after completing treatment.
  • Conduct liver function tests immediately if the patient shows any signs or symptoms of liver injury (such as nausea, vomiting, fatigue, jaundice, abdominal pain).

Health Canada is also advising healthcare providers to:

  • Inform your patients about the risk of 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 if the patient experiences liver injury.

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