Table 1.
Indications for recombinant human growth hormone (hGH) treatment approved by the U.S. Food and Drug Administration (FDA).
| Year of FDA approval | Indication | Therapeutic goal | |
|---|---|---|---|
| Restoration of normal growth/Height augmentation | Metabolic, body composition, and health benefits | ||
| Pediatrics | |||
| 1985 | GH deficiency | ✓ | ✓* |
| 1993 | Chronic renal insufficiency | ✓ | |
| 1996 | Turner syndrome | ✓ | |
| 2000 | Prader-Willi syndrome | ✓ | ✓* |
| 2001 | Small-for-gestational age without catch-up growth | ✓ | |
| 2003 | Idiopathic short stature | ✓ | |
| 2007 | SHOX gene haploinsufficiency | ✓ | |
| 2008 | Noonan syndrome | ✓ | |
| Adults | |||
| 1996 | HIV/AIDS-associated wasting | ✓ | |
| 1997 | GH deficiency | ✓ | |
| 2003 | Short bowel syndrome and dependent on parenteral nutrition (4-week course of hGH) | ✓ | |
*
All pediatric FDA approvals were specifically for height and growth considerations, but afterwards health benefits were recognized as well for patients with GH deficiency or Prader-Willi syndrome, which is associated with a high prevalence of GH deficiency.