Health Canada announces new label information for diabetes drug Actos

Published Friday December 19th, 2008

TORONTO - Health Canada has asked the maker of the diabetes drug Actos to beef up its label warning about the risk of heart failure in people taking the medication.

The department says it has been working with the manufacturer, Eli Lilly Canada, to strengthen label warnings to emphasize the need for proper use of the drug.

Actos, which is the brand name for the drug pioglitazone hydrochloride, is used to treat Type 2 diabetes.

Health Canada says that while previous labelling addressed the risk of heart failure, a safety assessment it conducted highlighted the need for new restrictions to better manage the risk.

While people with diabetes are at increased risk of developing heart failure and heart disease, Actos may further increase that risk and shouldn't be used by people with any history of heart failure.

The department says that people taking Actos who experience signs of heart failure including unusually rapid weight gain, swelling, weakness, or shortness of breath should immediately consult their health-care provider.

Actos can be used in combination with either metformin or a sulfonylurea, two other drugs used to treat diabetes. But it should not be used with both, Health Canada warns.

And the department says it is important to remember that Actos is not approved for use in combination with insulin.

 

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