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Many people with diabetes take insulin to control their blood sugar (glucose). Insulin cannot be taken by mouth because it would be destroyed by digestion. Instead, most people who need insulin take insulin shots. Other ways to take insulin include insulin pens, insulin jet injectors, and insulin pumps. Someday people with diabetes may no longer need needles or shots to take insulin; researchers are testing news ways to get insulin into the bloodstream.
Background Information about Insulin When we eat, our bodies break food down into organic compounds, one of
which is glucose. 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 1 diabetes produce no insulin. People with type 2 diabetes do not always produce enough insulin. There are more than 20 types of insulin products available in four basic forms, each with a different time of onset and duration of action. The decision as to which insulin to choose is based on an individual's lifestyle, a physician's preference and experience, and the person's blood sugar levels. Among the criteria considered in choosing insulin are:
To compare the features of the different types of insulin, use the following link:
The insulin products used by people with diabetes are either taken from animals (pigs or cows) or manufactured in labs to be identical to human insulin. Beef insulin is no longer available in the United States. Beginning in January 2006, pork insulin for human use will no longer be manufactured or marketed in the U.S. For information about importing beef or pork insulin for personal use, use the following link:
FDA has consumer information about several new types of insulin products. Pharmacists from CDER's Drug Information Branch prepare these information sheets based on the products' approved package inserts. For consumer information about each of these products, use the following links:
To search the Consumer Drug Information Page for another medication, use the following link:
FDA has labels (package inserts) for several types of insulin products. 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 any of the products listed below. These documents are in PDF format and require Adobe Acrobat to read.
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 for approved drugs. To go to the New and Generic Drug Approval web site, use the following link:
FDA's Center for Drug Evaluation and Research (CDER) oversees drug products, including insulin. CDER makes sure that drugs sold in the U.S. are safe and effective. The center evaluates new types of insulin products, and it regulates the manufacturing, labeling, and advertising of insulin products. Companies wanting to market insulin products are responsible for testing their products 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 a new insulin product is on the market, CDER monitors its quality and makes sure that its manufacturer follows FDA laws and regulations. CDER also monitors insulin products 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:
For more information about how FDA regulates insulin and other drugs, use the following links:
Types of Insulin Delivery Devices All insulin delivery devices inject insulin through the skin and into
the fatty tissue below. Syringes For more information about insulin syringes, use the following link:
Insulin Pens To search FDA's 510(k) database for syringes and insulin pens, use the following link: Jet Injectors To search FDA's 510(k) database for insulin jet injectors, use the following link: Insulin Pumps For more information about insulin pumps, use the following links:
To search FDA's 510(k) database for insulin pumps, use the following link:
Researchers are now developing several new methods for delivering insulin. These include the insulin patch and inhaled insulin. The insulin patch, when placed on the skin, will give a continuous, low dose of insulin. To adjust insulin doses before meals, users will pull off the tab on the patch to release insulin. Inhaled insulin delivery systems will give insulin as a dry power, inhaled through the mouth directly into the lungs where it passes into the bloodstream. This aerosol delivery system will likely be about the size of a flashlight and use rapid-acting insulin.
Companies that want to sell insulin delivery devices must show FDA that their devices are "substantially equivalent" to drug delivery devices already for sale. For information about how FDA regulates medical devices, use these links:
Updated July 6, 2005 |
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