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October 24, 1977

U-100 Insulin: A Progress Report

JAMA. 1977;238(17):1823-1824. doi:10.1001/jama.1977.03280180027018

IN FEBRUARY 1973, U-100 insulin (100 units/ml) was introduced in the United States by Eli Lilly & Company and a few months later by E. R. Squibb & Sons. The marketing of this strength of insulin was the culmination of many years of concern by the American Diabetes Association (ADA), the Food and Drug Administration, and the insulin manufacturers over medication errors that resulted from confusion between U-40 and U-80 insulins. Specifically, a few patients requiring U-40 insulin were inadvertently administering U-80, and marked hypoglycemia developed, while some requiring U-80 were using U-40 insulin with subsequent loss of control of the diabetes. Another hazard was the confusion frequently caused by the glass syringe marked with scales for both U-40 and U-80 insulins.

The concentration of U-100 (100 units/ml) was agreed on by the ADA, the FDA, the Canadian regulatory agency (Health Protection Branch), and manufacturers of insulin in the United