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Front Label Info

Elsewhere on the label, consumers may find claims about the food's nutritional benefits. These claims signal that the food contains desirable levels of certain nutrients.

Some claims, such as "low fat," "no saturated fat," and "high fiber," describe nutrient levels. Some of these are particularly interesting to people with diabetes because they highlight foods containing nutrients at beneficial levels.

Other claims, called health claims, show a relationship between a nutrient or food and a disease or health condition. FDA has authorized eight such claims; they are the only ones about which there is significant scientific agreement. [Note: Since this article was published, several more claims have been approved. For the most recent listing of such claims, see "A Food Labeling Guide — Appendix C" on FDA's Center for Food Safety and Applied Nutrition Website.]

Three that relate to heart disease are of particular interest to people with diabetes:

A diet low in saturated fat and cholesterol may help reduce the risk of coronary heart disease.

A diet rich in fruits, vegetables and grain products that contain fiber, particularly soluble fiber, and are low in saturated fat and cholesterol may help reduce the risk of coronary heart disease.

Soluble fiber from whole oats, as part of a diet low in saturated fat and cholesterol, may help reduce the risk of coronary heart disease.

Nutrient and health claims can be used only under certain circumstances, such as when the food contains appropriate levels of the stated nutrients.

Shot of Insulin

Taking regular injections of insulin is a must for some diabetics.

The first insulin marketed for diabetes was derived from the pancreas of cows and pigs. Today, chemically synthesized human insulin is the most often used. It is prepared from bacteria with DNA technology. Human insulin is not a great advantage over animal insulin, and most doctors don't recommend that patients on animal insulin automatically switch to human insulin. But if they do switch, dosages may change. Human insulin is preferred for those patients who take insulin intermittently.

Diabetics on intensified insulin therapy — that is, those needing multiple daily injections or an insulin pump, which is worn 24 hours a day — can have flexibility in when and what they eat. Other diabetics on insulin therapy must eat at consistent times, synchronized with the time-action of the insulin they use.

In 1996, FDA approved Humalog, which Robert I. Misbin, M.D., an FDA medical reviewer, describes as "a modified human insulin." Humalog is absorbed and dissipated more rapidly than regular human insulin. Humalog is of particular benefit because it offers convenience.

Oral Drugs

Adults with Type 2 diabetes may or may not be treated with one or more classes of oral diabetes drugs. The oldest class, sulfonylureas (SFUs), act on the pancreatic tissue to produce insulin. The newest one is Amaryl (glimepiride) approved by FDA in 1996.

Because SFUs can become less effective after 10 or more years of use, other drugs often are needed.

Another class is the biguanides, including metformin, which was approved by FDA in 1995. This drug acts by lowering cells' resistance to insulin, a common problem in Type 2 diabetes.

A third class is the alpha-glucosidase inhibitors, which include Precose (acarbose), approved by FDA in 1995, and Glyset (miglitol), approved in 1996. These drugs slow the body's digestion of carbohydrates, delaying absorption of glucose from the intestines.

A newer class of diabetes drugs is the thiazolidinediones. They include Rezulin (troglitazone), approved in 1997, and Avandia and Actos, both approved in 1999. These drugs improve a condition that seems to be an important underlying cause of adult onset diabetes — resistance of the body to insulin.

Though they act similarly, their approved uses vary. Rezulin, for example, is approved for use in combination with sulfonyureas and metformin. It should not be used as an initial single agent therapy and should be prescribed only in patients not adequately controlled by other therapies.

FDA approved Avandia for patients with diabetes who are not taking insulin and Actos for diabetics who are not adequately controlled by diet and exercise alone. Actos is approved for use with sulfonylureas, metformin or insulin in patients who are not adequately controlled on the these agents alone.

FDA recommends regular liver chemistry tests for patients receiving a thiazolidinedione. This recommendation is based on evidence of serious and sometimes fatal liver injury in patients treated with Rezulin. Though liver disease was not seen in clinical trials of Avandia and Actos, FDA recommends liver tests for patients on any of the approved thiazolidinediones. The recommendations are as follows:

Tags: Diabetes

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.