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Executive Summary

Oral sulfonylurea hypoglycemic drugs labeling should emphasize that the agents should be used only as adjuncts to diet in diabetes treatment, FDA stipulates in labeling guidelines for the drugs published in the April 11 Federal Register. The class of sulfonylurea oral agents, FDA's guidelines state, "is indicated as an adjunct to diet to lower the blood glucose in patients with non-insulin-dependent diabetes mellitus (type II) whose hyperglycemia cannot be controlled by diet alone." The indications section, FDA continues, should note that in initiating "treatment for non-insulin-dependent diabetes, diet should be emphasized as the primary form of treatment." The labeling guidelines will directly affect currently marketed products of the sulfonylurea class such as Pfizer's Diabinese (chlorpropamide) and Upjohn's Orinase (tulbutamide). However, publication of the guidelines may also signal that FDA will soon approve a group of second generation oral hypoglycemic agents which have been stalled in the NDA review pipeline while the agency considered the labeling question. Among these are glyburide, which is being sponsored both by Upjohn under the tradename Micronase and by patent-holder Hoechst under the name Diabeta, and Pfizer's Glucotrol (glipizide). The FDA guidelines discussion of the proper conditions for which the drugs are indicated declare that "proper dietary management" and "the importance of regular physical activity" should be stressed in labeling. Only if "this treatment program fails to reduce symptoms and/or blood glucose," should the use of an oral sulfonylurea or insulin be considered." In any case, the guidelines state that "use of [the drugs] must be viewed by both the physician and patient as a treatment in addition to diet, and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, the loss of blood glucose control on diet alone may be transient, thus requiring only short-term administration" of oral hypoglycemic agents. FDA explained that, except for the mandatory warning statement concerning cardiovascular mortality (see preceding story), the guidelines are for the purpose of assisting mfrs. to formulate labeling that is acceptable to the agency. "A person may choose to use alternative labeling statements that are not provided for in the guideline. If a person chooses to depart from the guideline, he or she may discuss the matter further with the agency to prevent expenditure of money and effort for labeling that the agency may later determine to be unacceptable," FDA said in a separate April 11 notice announcing the availability of the guidelines. Revised labeling will be required 180 days after publication, or Oct. 8, FDA said. The agency added that certain sections of the labeling, for example information on carcinogenesis, mutagenesis, teratogenic effects, and clinical pharmacology, and effects in nursing mothers, must receive prior approval from FDA. To meet the 180 day deadline, FDA said that the information to be reviewed by FDA should be submitted within 90 days of the April 11 publication (or by July 10). The guidelines state, under a section on information for patients, that "patients should be informed of the potential risks and advantages of the agents and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of urine and/or blood glucose."

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