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    Health Canada places restrictions on Allergan Fibroid treatment Esmya

    Farhat NasimWritten by Farhat Nasim Published On 2019-01-13T09:00:36+05:30  |  Updated On 16 Aug 2021 4:29 PM IST

    The drug is sold in Europe by Hungarian drugmaker Richter. Richter has said it considered Esmya to be a safe and effective form of treatment.


    Canada: Canada's health regulator on Friday said it was restricting the use of Allergan Plc's uterine fibroid treatment Esmya after discovering a risk of serious liver injury from the drug.


    Health Canada said the drug, sold under brand name Fibristal in the country, should not be used by women with liver problems, or those who have had such problems in the past.


    It also said that more than one treatment course of the drug should be restricted to only those of childbearing age who are unable to undergo surgery to remove the fibroids.


    The U.S. Food and Drug Administration in August declined to approve the drug, requesting more information and citing safety issues outside the United States.


    Regulators in Europe have also recommended restrictions on the use of the drug for some patients, to help minimize risks.


    The drug is sold in Europe by Hungarian drugmaker Richter. Richter has said it considered Esmya to be a safe and effective form of treatment.


    Allergan and Richter were not immediately available for comment.


    Also Read: FDA declines to approve Allergan's Esmya
    Allergancanada pharma newsdrugsEsmyaFDAFibroid treatmentfibroidsHealth Canadaliver injurymedicinespharma news in canadaRichterUSFDAuterine fibroid
    Source : Reuters

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    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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