DIF-HOME INDEX

 

                  American Diabetes AssociationAmerican Diabetes Association

The ADA's information here is a major step in the right direction and represents a total turnaround in their publicly stated policies of 11/15/1999. As usual it is way too little and way too late, and substantially incorrect, BUT at least they were, apparently, so embarrassed by Lilly's off the wall comments on diabetics sneezing 3 times and blaming it on insulin that they felt something should be done.

 

Update Regarding Discontinuation of Animal-Source Insulins

There continues to be concern among some people with diabetes about the discontinuation of some animal-source insulins in the United States. The American Diabetes Association continues to address this issue by remaining in contact with various interested parties, including the Food and Drug Administration and consumer-interest groups, in order to learn more information about this evolving issue.

The following statement outlines what the American Diabetes Association understands about the discontinuation of animal-source insulins in the United States and the options available to people with diabetes:

Background

Eli Lilly and Company stopped manufacturing Iletin I mixed beef-pork insulins in October 1998. These insulins included the following: Regular Iletin I (Insulin Injection, USP), NPH Iletin I (Isophane Insulin Suspension, USP), and Lente Iletin I (Insulin Zinc Suspension, USP). The company will continue to manufacture a purified pork insulin, called Iletin II.

In February 2000, Novo Nordisk Pharmaceuticals, Inc., announced that it is discontinuing its complete line of purified pork insulins. These include the following: Regular Purified Pork-R; Lente Purified Pork-L; NPH Purified Pork-N. Both Regular and NPH Purified Pork Insulins will be available through July 2000. However, the supply of Lente Purified Pork Insulin expired at the end of February 2000.

Many animal-source insulins that are manufactured by various companies have or are being discontinued because of the increase in the availability and use of human insulins.

Recommendations for Patients Beginning or Switching Insulin Therapy

Human insulin has become the insulin of first choice for newly diagnosed patients with diabetes and is recommended by the American Diabetes Association for patients beginning insulin therapy.

It is critical for patients to note that, as with any new medical treatment, starting or changing insulin should be done with caution and only under close medical supervision. The Association strongly encourages patients to work closely with their physicians and other health care providers to ensure the most successful transfer.

Options and Resources for Patients and Their Health Care Providers

  1. To report a bad reaction: Studies show that patients can be safely transferred from animal-source insulin to human insulin and that allergic reactions are rare. However, to report a bad reaction to any insulin or to file a complaint about the removal of animal-source insulins from the U.S. market, the Association recommends that patients and/or their physicians contact the Food and Drug Administration’s MedWatch at 1-800-332-1088 or http://www.fda.gov/medwatch/

  2. Resource through Eli Lilly: To help patients with the transfer from Eli Lilly’s mixed beef-pork insulin, Eli Lilly is offering a free transition kit. The kit must be ordered by physicians by calling Eli Lilly toll-free at 1-888-885-4559. Physicians who would like to learn more about transferring patients from Eli Lilly’s mixed beef-pork insulin may contact an on-site physician at Eli Lilly by calling toll-free at 1-888-885-4559.

  3. Resource through Novo Nordisk: Physicians who would like to learn more about transferring patients from Novo Nordisk’s purified pork insulins should call the company’s toll-free Information Hotline at 1-800-727-6500.

  4. Other ways to secure animal-source insulin: The American Diabetes Association recognizes that there are some people in the United States with diabetes who – along with their physicians – feel that animal-source insulin is the most appropriate treatment option.

          For people wishing to use beef and/or pork insulin, the Association has learned that beef insulin can be imported through the Food and Drug Administration’s (FDA) importation program. This can be done in two ways:

  • The American Diabetes Association has learned of a resource that may be helpful to people with diabetes and their physicians in getting beef insulin imported. The Insulin-Dependent Diabetes Trust U.S. is a non-profit consumer group that advises patients and their physicians on the necessary procedures for personal importation of beef insulin. The Insulin-Dependent Diabetes Trust U.S. may be contacted at PMB-405, 1720 Guess Road, Suite 40, Durham, NC 27701, 1-888-568-7237, http://www.iddtinternational.org/iddtinternational/us/index.htm.