The MHRA said that patients on the treatment combination should be closely observed for signs and symptoms of heart failure, weight gain, and oedema. It comes after cases of heart failure were reported when pioglitazone was used in combination with insulin.
A warning about co-treatment will now be added to the information included with insulin products. A similar warning has been included with pioglitazone since the product was launched.
The MHRA advised that pioglitazone should be discontinued if any deterioration in cardiac status occurs.
Warnings will be added to all insulin and pioglitazone products following a European review of the increased incidence of HF associated with the treatment combination.
Pioglitazone is marketed by Takeda as Actos and, in combination with metformin, as Competact. It is 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 spokesman for Takeda told GP the company welcomed the fact that warnings would be included on insulin products as well as pioglitazone. This would ensure, he said, that doctors and patients would be aware of the risk, whichever product they were given first.