Cases of cardiac failure have been reported when Pioglitazone was used in combination with Insulin, especially in patients with risk factors for the development of cardiac failure. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain, and oedema.

Pioglitazone is indicated for the treatment of type 2 diabetes either as monotherapy ( Actos ) or in combination with Metformin ( Competact ) and/or a sulphonylurea. Pioglitazone is also indicated in combination with Insulin for adults with type 2 diabetes with insufficient glycaemic control on Insulin for whom Metformin is inappropriate because of contraindications or intolerance.

A European review of the increased incidence of cardiac failure when Pioglitazone is used in combination with Insulin, especially in patients with predisposing factors, has recommended that the product information for Insulin should equally reflect this risk and contain appropriate warnings. The product information for Pioglitazone already contains warnings about its use in combination with insulin. Warnings are also being added to the product information for all Insulin products.

Advice for healthcare professionals

• Cases of cardiac failure have been reported when Pioglitazone was used in combination with Insulin, especially in patients with risk factors for the development of cardiac failure;

• If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain, and oedema;

• Pioglitazone should be discontinued if any deterioration in cardiac status occurs.

Source: Drug Safety Update, 2011

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