Diabetes Pills - FDA

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Diabetes Pills

Many people with type 2 diabetes take diabetes pills (oral diabetes medications). Diabetes pills only work for people whose pancreases still makes some insulin, so they can not help people with type 1 diabetes. Diabetes pills are not insulin. Instead, they help lower blood sugar (glucose) in other ways.

Diabetes Pills

Background Information about Diabetes Pills

Categories of Diabetes Pills

FDA Consumer Information about Diabetes Pills

Package Inserts for Diabetes Pills

Other Resources for Diabetes Pills

FDA's Role in Regulating Diabetes Pills

Common Questions About Diabetes Pills
Diabetes Pills

Background Information about Diabetes Pills

Our bodies need glucose as a source of energy for movement, growth, repair, and other functions. When we eat, our bodies break food down into organic compounds, one of which is glucose. But before the cells can use glucose, it must move from the bloodstream into the individual cells. This process requires insulin.

Insulin is produced by the beta cells in the islets of Langerhans in the pancreas. When glucose enters our blood, the pancreas should automatically produce the right amount of insulin to move glucose into our cells. People with type 2 diabetes either produce too little insulin, produce it too late to match the rise in blood glucose, or do not respond correctly to the insulin that is produced. Then glucose builds up in the blood, overflows into the urine, and passes out of the body. This means that the body loses its main source of energy even though the blood contains large amounts of glucose.

Diabetes pills work in one of three ways. They either stimulate the pancreas to release more insulin, increase the body's sensitivity to the insulin that is already present, or slow the breakdown of foods (especially starches) into glucose.

Categories of Diabetes Pills

There are six categories of diabetes pills: sulfonylureas, meglitinides, nateglinides, biguanides, thiazolidinediones, and alpha-glucose inhibitors.

To compare the features of each of these types of drugs, use the following link:

FDA Consumer magazine, Chart of Oral Anti-Diabetes Medications (January-February 2002)
http://www.fda.gov/fdac/features/2002/chrt_oralmeds.html

FDA Consumer Information about Diabetes Pills

FDA has consumer information about several new types of diabetes drugs. Pharmacists from CDER's Drug Information Branch prepare these information sheets based on the drug's approved package insert. For consumer information about each of these products, use the following links:

Actos Consumer Information
http://www.fda.gov/cder/consumerinfo/druginfo/actos.HTM

Avandia Consumer Information
http://www.fda.gov/cder/consumerinfo/druginfo/avandia.HTM

Starlix Consumer Information
http://www.fda.gov/cder/consumerinfo/druginfo/starlix.HTM

To search the Consumer Drug Information Page for another medication, use the following link:

FDA Consumer Drug Information
http://www.fda.gov/cder/consumerinfo/default.htm

Package Inserts for Diabetes Pills

FDA has labels (package inserts) for several types of diabetes drugs. Package inserts are written for health care providers. They contain very detailed information about different drugs. The manufacturers prepare this information, and FDA approves it. You can print or read copies of package inserts for the drugs listed below. These documents are in PDF format and require Adobe Acrobat to read.


Actos Label
http://www.fda.gov/cder/foi/label/1999/21073lbl.pdf

Avandia Label
http://www.fda.gov/cder/foi/label/1999/21071lbl.pdf

Glucophage XR Label
http://www.fda.gov/cder/foi/label/2000/21202lbl.pdf

Glucovance Label
http://www.fda.gov/cder/foi/label/2000/21178lbl.pdf

Prandin Label
http://www.fda.gov/cder/foi/label/2002/20741s12lbl.pdf

Starlix Label
http://www.fda.gov/cder/foi/label/2000/21204lbl.pdf

You can search for information about other drugs on the CDER New and Generic Drug Approvals web page. This is an alphabetical listing of most recently approved prescription drugs. It is updated on a daily basis and contains links to labels, approval letters, and reviews of approved drugs.

To go to the New and Generic Drug Approval web site, use the following link:

CDER New and Generic Drug Approvals
http://www.fda.gov/cder/approval/index.htm


FDA's Role in Regulating Diabetes Pills

FDA's Center for Drug Evaluation and Research (CDER) oversees drug products. CDER makes sure that drugs sold in the U.S. are safe and effective. The center evaluates new drug applications, and it regulates the manufacture, labeling and advertising of drug products. CDER doesn't test drugs, although it does do some research in drug quality, safety, and effectiveness.

Companies wanting to market drugs are responsible for testing them and submitting data showing they are safe and effective. At CDER, teams of doctors, statisticians, and scientists review new drug applications (NDAs). In some cases, FDA seeks help from advisory committees made up of outside experts.

Once drugs are on the market, CDER monitors their quality and makes sure that manufacturers follow FDA laws and regulations. CDER also monitors drugs carefully after they are approved to identify any unexpected side effects. Through a system called MedWatch, health professionals and consumers can report serious adverse reactions to any medical product. CDER collects information from MedWatch and the drug industry and conducts statistical evaluations on drug usage, adverse reactions, poisonings, safety, and effectiveness. If necessary, CDER shares information with patients and health professionals.

For general information about the MedWatch program and instructions for reporting problems with medical devices, use the following link:

MedWatch: The FDA Safety Information and Adverse Event Reporting Program
http://www.fda.gov/medwatch/how.htm

For more information about how FDA regulates diabetes pills and other drugs, use the following links:

FDA Consumer Magazine, Inside FDA: The Center for Drug Evaluation and Research (July-August 1996)
http://www.fda.gov/fdac/features/696_cder.html

CDER's Division of Metabolic and Endocrine Drug Products Home Page
http://www.fda.gov/cder/dmedp/index.htm

CDER: The Center for Drug Evaluation and Research Home Page
http://www.fda.gov/cder


Other Resources for Diabetes Pills

For more information about diabetes pills, use the following links:

NIDDK Medicines for People with Diabetes
A review of the different types of diabetes pills, instructions for use, and side effects.
http://www.niddk.nih.gov/health/diabetes/pubs/med/specific.htm#pills

American Diabetes Association: Oral Medications, Pills to Treat Type 2 Diabetes
http://www.diabetes.org/main/type2/medical/oral/c30c_copy(1).jsp