Key result
The use of human pituitary growth hormone was stopped in 1985 due to the risk of Jakob-Creutzfeldt disease and was subsequently replaced by FDA-approved synthetic human growth hormone.
The transition from human pituitary growth hormone to biosynthetic growth hormone mitigated the risk of Jakob-Creutzfeldt disease and expanded treatment access for growth hormone deficiency.
Almost 4 decades have passed since the treatment of growth hormone deficiency with human pituitary growth hormone (GH) was first reported in 1958.5hInitially, the number of children treated with GH was small, and fewer than 100 patients were started on treatment in the United States in the following 4 years.The National Pituitary Agency was begun under the sponsorship of the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) in 1962 to organize the collection of pituitary glands at the time of autopsy and the purification and distribution of GH.The increase in the therapeutic use of GH in the United States was almost logarithmic for the next 2 decades,'* and by 1985 approximately 3000 patients in the United States were under treatment with human pituitary growth hormone (Fig. 1).Because of the limited supply of pituitary GH, only about half of the severely growth hormone deficient patients could be treated, doses of GH were limited and the supply of GH for the patients was often interrupted.In 1985, several patients who had been treated with pituitary GH were reported to have developed Jakob-Creutzfeldt disease at an unusually young age.31Because of the potential risk of Jakob-Creutzfeldt infection, the use of pituitary growth hormone in the United States was stopped in early 1985.Fortunately, clinical trials of biosynthetic GH had been conducted since 1982,3O and several months after the withdrawal of pituitary GH the use of synthetic human growth hormone for the treatment of GH insufficiency was approved by the FDA in the United States.By the end of 1986 the number of patients on growth hormone in the United States had doubled to
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Raymond L. Hintz (1996) conducted a review in Growth hormone deficiency. Growth hormone was evaluated. The use of human pituitary growth hormone was stopped in 1985 due to the risk of Jakob-Creutzfeldt disease and was subsequently replaced by FDA-approved synthetic human growth hormone.
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