Health Canada restricts Allergan's Esmya

Pharma Times

15 January 2019 - Health Canada has placed restrictions on Allergan's uterine fibroid treatment Esmya, after discovering a possible link between its use and the risk of a rare but serious liver injury.

The regulator has announced that the drug, sold under brand name Fibristal in the country, should not be used by women with liver problems, or by those who have had liver problems in the past.

It also stated 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 drug has also been rejected by the US FDA, requesting more information and citing safety issues outside the United States.

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Michael Wonder

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Michael Wonder

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Medicine , Regulation , Canada , Safety