Health Canada announced on Friday that it is imposing new restrictions on Allergan Plc’s treatment for uterine fibroids, Esmya, following concerns over potential serious liver damage.
The drug, marketed under the name Fibristal in Canada, should no longer be used by women with liver issues or those with a history of liver problems. Additionally, Health Canada stated that patients of childbearing age who cannot have surgery to remove fibroids may only be given the drug for a single treatment course.
In August, the U.S. Food and Drug Administration (FDA) declined to approve Esmya. The FDA requested more information and cited safety concerns that extend beyond the U.S.
European regulators have also suggested limiting the use of the drug to reduce risks. In Europe, Esmya is sold by the Hungarian pharmaceutical company, Richter. Richter has defended the drug, maintaining that it is both safe and effective.
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