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Dr. Bill's Commentaries

I probably should do that   (February 9, 2009)

The "off-label use" of medications is common. I'll define off-label use as a recommendation by a physician to their patient to use a prescription medication to treat a medical condition that hasn't been approved for that medication by the FDA or other Health Authority. As most folks know, regulators review studies on a medication that are submitted by the manufacturer, and if the regulators consider the quality of the data from the studies to be sufficient, they allow the manufacturer to add additional information to the label, including new indications for the drug that weren't previously authorized.

Common examples of off-label use in the diabetes area include:

* use of metformin (a widely-used medication for type 2 diabetes) in people diagnosed with pre-diabetes. No medications are approved for use in pre-diabetes, although major studies such as the DPP have found that drugs can help.

* use of glyburide (a sulfonylurea medication for type 2 diabetes) in pregnant women with diabetes. Studies have found that this pill works almost as well as insulin in women with gestational diabetes.

* use of insulin and Byetta (exenatide) at the same time: Byetta is not approved for use with insulin. [Editor's note: Update: Byetta has subsequently been approved for use with Lantus insulin.]

* use of Lantus (insulin glargine) on a twice-a-day basis: it's only approved for once-daily dosing.

* use of Lantus by children under age 6: it's only approved for ages 6 and older.

Please be aware, physicians are not required to follow the label's restrictions concerning how to use a medication. However, if something goes wrong, and the physician is sued, the

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Dr. Bill Quick began writing at HealthCentral's diabetes website in November, 2006. These essays are reproduced at D-is-for-Diabetes with the permission of HealthCentral.



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