(Reuters) – 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.
Reporting by Manas Mishra in Bengaluru; Editing by Shinjini Ganguli