Allergan withdraws ulipristal from Canada due to serious liver injury
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Allergan withdraws ulipristal from Canada due to serious liver injury Allergan, the manufacturer of ulipristal 5mg tablets (Fibristal), is voluntarily withdrawing this product from the Canada due to the risk of serious drug-induced liver injury (DILI), says Health Canada. Fibristal was approved in Canada to treat signs and symptoms of uterine fibroids in women of reproductive age. A "Dear Healthcare Professional" letter was recently issued after Health Canada announced on 16 September 2020 that it was conducting another review in response to "rare international cases of severe liver injury requiring liver transplantation", noted the agency. Also playing a role in its decision was the EMA Pharmacovigilance Risk Assessment Committee’s recommendation to revoke the marketing authorisation for the EU’s ulipristal medicine (Esmya). Back in January 2019, the agency reported that it had conducted a safety review of Fibristal, which concluded that use of this drug may be linked with a risk of DILI.* At that point, updates to the Canadian Product Monograph were made to reflect this safety risk. On 24 September 2020, Allergan initiated a recall of Fibristal to the retail pharmacy level within the Canadian market. Healthcare professionals are advised to: • not prescribe or dispense Fibristal; • contact patients who are currently receiving Fibristal to cease treatment and review alternative treatment options; • advise patients to seek immediate medical attention if they experience signs and symptoms of liver injury** after stopping Fibristal treatment; and • perform liver function monitoring within 2–4 weeks after stopping Fibristal treatment, and to investigate further if liver function is abnormal. * see Reactions 1737 p5; 803370846 ** including nausea, vomiting, stomach ache, severe tiredness, yellowing of the eyes or skin, or dark urine. Health Canada. FIBRISTAL (ulipristal acetate tablets, 5 mg) - Voluntary Withdrawal in Canada due to Risk of Drug-Induced Liver Injury. Internet Document : 30 Sep 2020. 803509204 Available from: URL: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74063a-eng.php
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Reactions 17 Oct 2020 No. 1826
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