Allergan Inc. voluntarily withdraws its drug Fibristal, used to treat uterine fibroids, from the Canadian market

Starting date:
September 16, 2020
Posting date:
September 30, 2020
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public, Healthcare Professionals
Identification number:
RA-73939

Last updated:

Summary

  • Product: Fibristal (ulipristal acetate)
  • Issue: Risk of serious liver injury associated with the use of Fibristal
  • What to do: Stop taking Fibristal. Report any signs and symptoms of liver injury such as nausea, vomiting, stomach ache, severe tiredness, yellowing of the eyes or skin, or dark urine to your healthcare provider immediately.

Update: September 30, 2020

OTTAWA – Health Canada is informing Canadians that Allergan Inc. has decided to withdraw the drug Fibristal (ulipristal acetate), used to treat uterine fibroids, from the Canadian market. Allergan made this decision in response to a number of international cases of serious liver injury requiring liver transplantation. The company determined that it is not possible to identify which patients are most at risk of developing liver injury, nor any measures that could further reduce the risk.

On September 24, 2020, Allergan Inc. initiated the recall of Fibristal from the Canadian market.

Health Canada is monitoring the effectiveness of the recall and advising patients who take Fibristal to:

  • stop treatment and contact their doctor to discuss other treatment options;
  • immediately report to their doctor signs and symptoms of liver injury such as nausea, vomiting, stomach ache, severe tiredness, yellowing of the eyes or skin, or dark urine, which could occur after stopping treatment; and
  • contact Allergan Inc. at 1-800-668-6424 or MR-Pharmacovigilance@allergan.com if you would like more information about the recall.

Healthcare professionals are advised to:

  • stop prescribing or dispensing Fibristal; and
  • to perform liver function monitoring on patients within two to four weeks after treatment with Fibristal has stopped and investigate further if liver function is abnormal

Health Canada has issued another communication for healthcare professionals.

The main ingredient in Fibristal, Ulipristal acetate, is also authorized as an emergency contraceptive that is taken only as a single dose. The recall does not affect this medication, sold under the brand name ella®.

Original Public Advisory: September 16, 2020 – Health Canada reviews safety of drug Fibristal again following new case of liver injury

OTTAWA – 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 authorization 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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