Safety Alerts & Recalls

What does this mean?

The benefits of treatment with both insulin and pioglitazone (also known by the brand name Actos or Competact) will continue to outweigh the risks for most patients. If you are taking either, or both, of these medicines you should not stop taking them unless advised to do so by your doctor. If you develop any symptoms such as breathlessness, tiredness or swelling of the legs or arms (oedema), you should report these symptoms to your doctor. If you have any other concerns about your treatment or side effects about this alert then please discuss these with your own doctor or other healthcare professional.

Pioglitazone Combined With Insulin Linked To Increased Risk of Heart Failure

The Medicines and Healthcare Products Regulatory Agency (MHRA) has notified healthcare professionals regarding an increased risk of heart failure among patients treated with a combination of pioglitazone (Actos) and insulin. The risk is greatest among patients with existing risk factors for the development of heart failure, such as raised blood pressure, previous heart attack, or disease of the blood vessels supplying the heart.

Pioglitazone is used in the treatment of type 2 diabetes and works by increasing the body’s sensitivity to insulin. It can be used alone (brand name Actos) or in combination with metformin (brand name Competact) and/or a sulphonylurea, or in combination with insulin. Product information for pioglitazone already contains warnings about its use in combination with insulin. Warnings are being added to the product information for all insulin products.

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Source: MHRA
Publication Date: 2011-03-11
Last Updated: 2011-05-12

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