FDA-approved uses for HGH?
HGH Deficiency in Children Growth hormone deficiency is treated by replacing GH. All GH prescribed in North America, Europe, and most of the rest of the world is a human GH, manufactured by recombinant DNA technology. As GH is a large peptide molecule, it must be injected into subcutaneous tissue or muscle to get it into the blood. Nearly painless insulin syringesmake this less trying than is usually anticipated, but perceived discomfort is a subjective value.When a person has had a long-standing deficiency of GH, benefits of treatment are often obvious[citation needed], and side-effects of treatment are rare. When treated with GH, a deficient child will begin to grow faster within months. Other benefits may be noticed, such as increased strength, progress in motor development, and reduction of body fat. Side-effects of this type of physiologic replacement are quite rare. Known risks and unsettled issues are discussed below, but GH-deficient children receiving replacement doses are at the lowest risk for problems[citation needed].Still, costs of treatment in terms of money, effort, and perhaps quality of life are substantial. Treatment of children usually involves daily injections of growth hormone, usually for as long as the child is growing. Lifelong continuation may be recommended for those most severely deficient as adults. Most pediatric endocrinologists monitor growth and adjust dose every 3?4 months. Assessing the psychological value of treatment is difficult, but most children and families are enthusiastic once the physical benefits begin to be seen. Treatment costs vary by country and by size of child, but $US 10,000 to 30,000 a year is common.
Little except the cost of treating severely deficient children is controversial, and most children with severe growth hormone deficiency in the developed world are offered treatment. Most accept. The story is very different for adult deficiency.[citation needed]

[edit] Growth hormone deficiency in Adults GH replacement therapy can provide a number of measurable benefits to severely GH-deficient adults. These include improved bone density.[1] Increased Muscle mass, decrease of adipose tissue, faster hair and nail growth, strengthend immune system, increased circulatory system, and improved blood lipid levels. Long term mortality benefit has not yet been demonstrated.[2]

GH for severe adult deficiency is usually prescribed as daily injections at a weekly dose about 25% of children’s doses and comparably lower cost. Despite the potential benefits, most adults with GH deficiency are not being treated due to a combination of factors such as unwillingness of some adults to seek medical care, unacceptability of injections, inadequate insurance coverage, and significantly lower rates of diagnosis and treatment offered by internist endocrinologists.

[edit] Other FDA-approved uses for HGH As of 2004, GH has been approved by the U.S. Food and Drug Administration for treatment of five other conditions in children and one other indication in adults:

In adults, wasting (or Cachexia) caused by AIDS.
Turner syndrome epitomizes the response of non-deficient shortness. At doses 20% higher than those used in GH deficiency, growth accelerates. With several years of treatment the median gain in adult height is about 2?3 in (5.1?7.6 cm) on this dose. The gains appear to be dose-dependent.[3] It has been used successfully in toddlers with Turner syndrome,[4] as well as in older girls.[5]
Chronic renal failure results in many problems, including growth failure. GH treatment for several years both before and after transplantation may prevent further deceleration of growth and may narrow the height deficit, though even with treatment net adult height loss may be about 4?in (10 cm).
Prader-Willi syndrome, a generally non-hereditary genetic condition, is a case where GH is prescribed for benefits in addition to height. GH is now standard care for children with PWS in the United States, when prescribed with appropriate precautions by an experienced endocrinologist.[citation needed] GH can help children with PWS in height, weight, body mass, strength, and agility.[citation needed]. Reports have indicated increase of growth rate (especially in the first year of treatment) and a variety of other positive effects, including improved body composition (higher muscle mass, lower fat mass); improved weight management; increased energy and physical activity; improved strength, agility, and endurance; and improved respiratory function. The Prader-Willi Syndrome Association (USA) recommends that a sleep study be conducted before initiating GH treatment in a child with PWS. At this time there is no direct evidence of a causative link between growth hormone and the respiratory problems seen in PWS (among both those receiving and those not receiving GH treatment), including sudden death. A follow-up sleep study after one year of GH treatment may also be indicated. GH (specifically Pfizer’s version, Genotropin) is the only treatment that has received an FDA indication for children with PWS. The FDA indication only applies to children.
Children short because of intrauterine growth retardation are small for gestational age at birth for a variety of reasons. If early catch-up growth does not occur and their heights remain below the third percentile by 2 or 3 years of age, adult height is likely to be similarly low. High-dose GH treatment has been shown to accelerate growth, but data on long term benefits and risks are limited.[6]
Idiopathic short stature (ISS) is one of the most controversial indications for GH as pediatric endocrinologists do not agree on its definition, diagnostic criteria, or limits.[7] The term has been applied to children with severe unexplained shortness that will result in an adult height below the 3rd percentile. In the late 1990s, the pharmaceutical manufacturer Eli Lilly and Company sponsored trials of Humatrope (their brand of rHGH) in children with extreme ISS, those at least 2.25 standard deviations below mean (in the lowest 1.2 percent of the population). These boys and girls appeared to be headed toward heights of less than 63″ (160?cm) and 59″ (150?cm) respectively. They were treated for about 4 years and gained 1.5?3 in (3.8?7.6 cm) in adult height. Controversy has arisen as to whether all of these children were truly “short normal” children, since the average IGF1 was low. It was not surprising that approval for this extreme degree of shortness led to an increase in the number of parents seeking treatment to make otherwise healthy children a little taller.[8]
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