N. D. Harris
Jul 1, 1981
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Influential Citations
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Journal
Therapeutic Innovation & Regulatory Science
Abstract
Phenformin hydrochloride (trademarks:DBI, DBITD, Melrrol) was first marketed in the United States in 1959 as an oral drug to lower blood sugar in the treatment of adult-onset diabetes. It is an oral hypoglycemic agent in the biguanide family, differing from the sulfonylureas both in chemical structure and in mode of action. It has not been shown to reduce either the incidence or severity of long-term complications of diabetes. The association of phenformin with lactic acidosis-a serious metabolic disorder which is fatal in nearly 50% of cases-was first reported in the early 1960's and warnings about lactic acidosis had been included in the labeling for the drug since 1964. The unacceptably high risk of lactic acidosis associated with the use of phenformin prompted the FDA's Endocrinology and Metabolism Advisory Committee to recommend, in October 1976, that it be removed from the market on grounds that the risk of occurrence of lactic acidosis is not justified by sufficient compensating benefit.'