Health Canada issues warning on two AbbVie hepatitis C treatments

12 November 2015

Medicines regulator Health Canada has issued a safety warning on two news hepatitis treatments from US drugmaker AbbVie (NYSE: ABBV), adding to similar warnings from the US Food and Drug Administration last month (The Pharma Letter October 23).

In response to new international safety information, Health Canada is advising Canadians that it is working with the manufacturer of Holkira Pak (fixed dose combination of ombitasvir/paritaprevir/ritonavir; and dasabuvir; US trade name Viekira Pak) and Technivie (fixed dose combination of ombitasvir/paritaprevir/ritonavir) to update drug labels (product monographs) to include new information regarding serious liver injury.

Holkira Pak and Technivie are both used to treat chronic hepatitis C viral infection that can lead to serious liver and health problems, including cirrhosis, liver cancer, and death. These medicines reduce the amount of hepatitis C virus in the body by preventing the virus from multiplying, which may slow down the disease.

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