Actos

Pioglitazone

For Type 2 Diabetes

Track record

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Long (approved in 1999)

Special FDA warning?

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Yes - FDA requires black box warning

Bottom line

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Type 2 Diabetes

What is Type 2 Diabetes?

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In type 2 diabetes, the pancreas produces enough insulin, at least in the early years of the disease. But for reasons that are still not well understood, the body’s cells become resistant or insensitive to it. As a result, the telltale marker — and problem — of diabetes emerges: glucose levels rise in the blood because it is unable to enter the body’s cells. The excess glucose is damaging to the body’s tissue and leads to the symptoms and complications of diabetes.

Other treatments for Type 2 Diabetes

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Non-drug

Over-the-counter

Prescription

TABLE OF CONTENTS

Overview

FDA-approved use

To help control blood sugar in adults with type 2 diabetes

Who might consider taking it?

Adults with type 2 diabetes whose blood sugar is not controlled by diet and exercise. Actos is NOT for treatment of type 1 diabetes or diabetic ketoacidosis.

What is not known

There is no evidence showing that Actos reduces your chance of stroke, heart attack, or vascular disease

Not tested in children younger than 18 years

The effect of Actos on babies during pregnancy is unknown. If you are pregnant or plan to become pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.

Track record

LONG TRACK RECORD

Long track record means that new‚ unexpected side effects are unlikely. Actos was approved by FDA in 1999. Since Actos has now been used by large numbers of people over a long time‚ the emergence of rare but serious side effects is less likely than with new drugs.

Open questions

No FDA-required studies at approval

Do not take if you...

Have severe heart failure

Have type 1 diabetes

Have diabetic ketoacidosis (increased ketones in blood or urine)

Are allergic to Actos

Safe if pregnant or breastfeeding?

Pregnant

Only take if potential benefits outweigh potential harm to baby (FDA Category C)

Breastfeeding

Unknown if Actos gets into breast milk

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