Markham, Ontario – September 30, 2020 – Allergan Inc., an AbbVie Company, is working closely with Health Canada to voluntarily withdraw FIBRISTAL® (ulipristal acetate tablets, 5 mg) across Canada. Allergan has reviewed the benefits and risks for FIBRISTAL® following reports of rare cases of severe liver injury requiring liver transplantation in Europe and has decided to remove the medication from the Canadian market.
FIBRISTAL® is approved in Canada for preoperative treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age AND for intermittent treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.i The duration of each FIBRISTAL® treatment course is three months.ii
FIBRISTAL® Voluntary Withdrawal
Any Canadian taking FIBRISTAL® should halt their treatment and contact their doctor to discuss alternative treatment options. Patients who are being treated with FIBRISTAL® should be advised to immediately report 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. Doctors are being advised to immediately contact their patients who have been prescribed FIBRISTAL® and discuss alternative treatment options. Patients should complete liver functioning monitoring within 2-4 weeks after treatment with FIBRISTAL® has stopped to investigate abnormal liver functioning. Should any Canadian patients or healthcare professionals have questions about FIBRISTAL®, please contact our Medical Information team: MR-MedicalInformation@Allergan.com or 1-800-668-6424.
Why is this Happening?
Rare cases of liver injury, including cases of serious liver impairment requiring liver transplantation, have been reported internationally in patients using ulipristal acetate tablets, 5 mg. It has been determined that it is not possible to identify which patients are most at risk for developing liver injury, or identify measures that could further reduce the risk. No cases of serious liver impairment leading to transplantation have been reported in Canada. Approximately 960,000 patients have been exposed to ulipristal acetate 5 mg worldwide from February 2012 through June 2020 and 5 cases of severe liver injury requiring liver transplantation were reported. There have been no reported cases of liver transplant in Canada. Approximately 70,000 patients have been treated with FIBRISTAL® in Canada since it’s Health Canada approval in June 2013. Allergan reviewed the benefits and risks for FIBRISTAL® and decided to proactively remove the medication from the Canadian market. As patient safety is our upmost priority, we decided to implement a voluntary withdrawal in Canada as soon as possible.
In March 2018, Health Canada initiated a safety review and later issued an Information Update informing healthcare professionals of the need to monitor liver function during and after treatment, and recommended not to use FIBRISTAL® in patients with liver disease.iii
About Uterine Fibroids
Seventy to eighty per cent of Canadian women of reproductive age have uterine fibroids, which are the leading cause of hysterectomies in Canada.iv The most common symptom of uterine fibroids is abnormal uterine bleeding, which causes pain and heavy, prolonged periods.v If left untreated, uterine fibroids can impact fertility and cause complications during pregnancy.vi In a Canadian survey of over 11,000 women aged 20 to 49, those who had uterine fibroids with moderate to severe symptoms experienced a significantly heavier burden of illness, lost productivity and reduced quality of life.vii Symptoms of uterine fibroids usually resolve with menopause, at which time treatments are stopped.
Women’s Health
Allergan and AbbVie are committed to women’s health by supporting research and developing treatment options to address some of the greatest treatment needs. Endometriosis is a chronic inflammatory disease that predominantly affects women of reproductive age.viii AbbVie has conducted some of the largest clinical trials in endometriosis in the world. We remain committed to women’s health and supporting optimal patient care.
iFIBRISTAL Product Monograph : https://allergan-web-cdn-prod.azureedge.net/allergancanadaspecialty/allergancanadaspecialty/media/actavis-canada-specialty/en/products/pms/2019-07-03-fibristal-pm-english.pdf
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iiiSummary Safety Review – FIBRISTAL (5 mg ulipristal acetate) – Health Canada. 2018-09-07. https://hpr-rps.hres.ca/reg-content/summary-safety-review-detail.php?lang=en&linkID=SSR00210
ivVilos GA et al. SOGC Clinical Practice Guidelines: The Management of Uterine Leiomyomas: Introduction and Medical Management. J Obstet Gynaecol Can 2015;37(2):157-178.
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viVilos GA et al. SOGC Clinical Practice Guidelines: The Management of Uterine Leiomyomas: Introduction and Medical Management. J Obstet Gynaecol Can 2015;37(2):157-178.
viiIBID
viiiYourPeriod.ca. What is Endometriosis? https://www.yourperiod.ca/endometriosis/what-is-endometriosis/ Accessed May 2020.