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MARKHAM, ON, Sept. 30, 2020 /CNW/ – Allergan Inc., an AbbVie Firm, is working intently with Well being Canada to voluntarily withdraw FIBRISTAL® (ulipristal acetate tablets, 5 mg) throughout Canada. Allergan has reviewed the advantages and dangers for FIBRISTAL® following experiences of uncommon instances of extreme liver damage requiring liver transplantation in Europe and has determined to take away the remedy from the Canadian market.
FIBRISTAL® is authorized in Canada for preoperative therapy of reasonable to extreme indicators and signs of uterine fibroids in grownup girls of reproductive age AND for intermittent therapy of reasonable to extreme indicators and signs of uterine fibroids in grownup girls of reproductive age who usually are not eligible for surgical procedure.i The period of every FIBRISTAL® therapy course is three months.ii
FIBRISTAL® Voluntary Withdrawal
Any Canadian taking FIBRISTAL® ought to halt their therapy and make contact with their physician to debate various therapy choices. Sufferers who’re being handled with FIBRISTAL® needs to be suggested to instantly report indicators and signs of liver damage (comparable to nausea, vomiting, abdomen ache, extreme tiredness, yellowing of the eyes or pores and skin or darkish urine), which might happen after stopping therapy. Medical doctors are being suggested to instantly contact their sufferers who’ve been prescribed FIBRISTAL® and focus on various therapy choices. Sufferers ought to full liver functioning monitoring inside 2-Four weeks after therapy with FIBRISTAL® has stopped to research irregular liver functioning. Ought to any Canadian sufferers or healthcare professionals have questions on FIBRISTAL®, please contact our Medical Data staff: [email protected] or 1-800-668-6424.
Why is that this Taking place?
Uncommon instances of liver damage, together with instances of great liver impairment requiring liver transplantation, have been reported internationally in sufferers utilizing ulipristal acetate tablets, 5 mg. It has been decided that it isn’t attainable to determine which sufferers are most in danger for creating liver damage, or determine measures that might additional cut back the chance. No instances of great liver impairment resulting in transplantation have been reported in Canada. Roughly 960,000 sufferers have been uncovered to ulipristal acetate 5 mg worldwide from February 2012 by means of June 2020 and 5 instances of extreme liver damage requiring liver transplantation have been reported. There have been no reported instances of liver transplant in Canada. Roughly 70,000 sufferers have been handled with FIBRISTAL® in Canada because it’s Well being Canada approval in June 2013. Allergan reviewed the advantages and dangers for FIBRISTAL® and determined to proactively take away the remedy from the Canadian market. As affected person security is our upmost precedence, we determined to implement a voluntary withdrawal in Canada as quickly as attainable.
In March 2018, Well being Canada initiated a security evaluate and later issued an Information Update informing healthcare professionals of the necessity to monitor liver perform throughout and after therapy, and advisable to not use FIBRISTAL® in sufferers with liver illness.iii
About Uterine Fibroids
Seventy to eighty per cent of Canadian girls of reproductive age have uterine fibroids, that are the main reason behind hysterectomies in Canada.iv The commonest symptom of uterine fibroids is irregular uterine bleeding, which causes ache and heavy, extended durations.v If left untreated, uterine fibroids can influence fertility and trigger issues throughout being pregnant.vi In a Canadian survey of over 11,000 girls aged 20 to 49, those that had uterine fibroids with reasonable to extreme signs skilled a considerably heavier burden of sickness, misplaced productiveness and decreased high quality of life.vii Signs of uterine fibroids normally resolve with menopause, at which period therapies are stopped.
Girls’s Well being
Allergan and AbbVie are dedicated to girls’s well being by supporting analysis and creating therapy choices to handle a number of the best therapy wants. Endometriosis is a power inflammatory illness that predominantly impacts girls of reproductive age.viii AbbVie has performed a number of the largest medical trials in endometriosis on the planet. We stay dedicated to girls’s well being and supporting optimum affected person care.
We’re an organization that takes on the hardest well being challenges.
AbbVie’s mission is to find and ship progressive medicines that clear up severe well being points as we speak and tackle the medical challenges of tomorrow. We try to have a outstanding influence on folks’s lives throughout a number of key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, girls’s well being and gastroenterology, along with services throughout its Allergan Aesthetics portfolio. For extra details about AbbVie, please go to us at www.abbvie.ca and www.abbvie.com. Comply with @abbviecanada on Twitter or discover us on Facebook, LinkedIn and Instagram.
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
iii Abstract Security Evaluate – FIBRISTAL (5 mg ulipristal acetate) – Well being Canada. 2018-09-07. https://hpr-rps.hres.ca/reg-content/summary-safety-review-detail.php?lang=en&linkID=SSR00210
iv Vilos GA et al. SOGC Scientific Observe Pointers: The Administration of Uterine Leiomyomas: Introduction and Medical Administration. J Obstet Gynaecol Can 2015;37(2):157-178.
vi Vilos GA et al. SOGC Scientific Observe Pointers: The Administration of Uterine Leiomyomas: Introduction and Medical Administration. J Obstet Gynaecol Can 2015;37(2):157-178.
viii YourPeriod.ca. What’s Endometriosis? https://www.yourperiod.ca/endometriosis/what-is-endometriosis/ Accessed Could 2020.
SOURCE Allergan, an AbbVie Firm
For additional info: MEDIA CONTACTS: Jennifer Gordon, Head of Communications, Allergan Inc., an AbbVie Firm, [email protected]; Rob McEwan, Argyle Public Relationships, [email protected], T. 416 968-7311 ext.241
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