Glucophage

Metformin

For Type 2 Diabetes

Track record

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Long (approved in 1995)

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 and children age 10-16 with type 2 diabetes

Who might consider taking it?

Adults and children age 10-16 with type 2 diabetes whose blood sugar is not controlled by diet and exercise. Glucophage is NOT for treatment of type 1 diabetes or diabetic ketoacidosis.

What is not known

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

Not tested in children less than 10 years

How Glucophage affects babies during pregnancy is unknown

Track record

LONG TRACK RECORD

Long track record means that new, unexpected side effects are unlikely. Glucophage was approved by FDA in 1995. Since Glucophage 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...

Are allergic to metformin

Have kidney disease or reduced kidney function on blood tests

Blood creatinine level 1.5 or higher (men), 1.4 or higher (women)

Have diabetic ketoacidosis (increased ketones in blood or urine)

Are 80 years or older and have NOT had your kidney function tested

Glucophage can be dangerous if kidney function is reduced. Need to make sure kidney function is okay before starting.

Have type 1 diabetes

Safe if pregnant or breastfeeding?

Pregnant

No evidence that Glucophage harms baby (FDA Category B - second safest rating)

Breastfeeding

Do not breastfeed while taking Glucophage - either stop breastfeeding or stop Glucophage

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