Summary Of Exposure |
A) WITH THERAPEUTIC USE
1) Peripheral edema, pancreatitis, hypo- and hyperglycemia, hypothyroidism, intracranial hypertension, carpal tunnel syndrome, gynecomastia and increased alkaline phosphatase have been reported following the therapeutic use of growth hormones. 2) Somatrem for injection is administered after reconstitution with bacteriostatic water for injection containing benzyl alcohol as an antimicrobial preservative. Benzyl alcohol has been associated with toxicity in newborns. a) Refer to "BENZYL ALCOHOL" management for further information.
B) WITH POISONING/EXPOSURE
1) Somatrem is a growth hormone derived from recombinant DNA technology. Overdose data are limited.
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Cardiovascular |
3.5.2) CLINICAL EFFECTS
A) EDEMA 1) WITH THERAPEUTIC USE a) Mild and transient peripheral edema has been reported infrequently (S Sweetman , 2002; USPDI , 2002; Prod Info Protropin(R), somatrem, 2001).
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Neurologic |
3.7.2) CLINICAL EFFECTS
A) BENIGN INTRACRANIAL HYPERTENSION 1) WITH THERAPEUTIC USE a) Benign intracranial hypertension with papilledema (visual changes, headache, nausea and vomiting) has been reported in several patients treated with growth hormone products. Symptoms usually occurred within the first 8 weeks of therapy and resolved upon discontinuation of the therapy or a reduction of the growth hormone dose (S Sweetman , 2002; USPDI , 2002; Prod Info Protropin(R), somatrem, 2001; Malozowski et al, 1995b).
B) SECONDARY PERIPHERAL NEUROPATHY 1) WITH THERAPEUTIC USE a) Rare cases of carpal tunnel syndrome have been reported (S Sweetman , 2002; USPDI , 2002; Prod Info Protropin(R), somatrem, 2001).
2) WITH POISONING EXPOSURE a) Bilateral median neuropathy, confirmed by nerve conduction velocities, developed in a male body builder during a self administered course of growth hormone (Dickerman et al, 2000).
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Gastrointestinal |
3.8.2) CLINICAL EFFECTS
A) PANCREATITIS 1) WITH THERAPEUTIC USE a) Pancreatitis has been reported following the use of somatrem (S Sweetman , 2002; USPDI , 2002; Prod Info Protropin(R), somatrem, 2001).
b) CASE REPORT - A 12-year-old boy with pseudohypoparathyroidism and growth hormone deficiency, developed acute pancreatitis (serum amylase 798 U/L; lipase 320 U/L) after receiving 6 doses of growth hormone (0.05 mg/kg/day). Symptoms resolved upon discontinuation of the growth hormone therapy. Upon rechallenge, the patient developed similar symptoms (Malozowski et al, 1995a).
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Hepatic |
3.9.2) CLINICAL EFFECTS
A) ALKALINE PHOSPHATASE RAISED 1) WITH THERAPEUTIC USE a) Increased alkaline phosphatase may occur with somatrem use (USPDI , 2002; Prod Info Protropin(R), somatrem, 2001).
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Dermatologic |
3.14.2) CLINICAL EFFECTS
A) DISORDER OF SKIN 1) WITH THERAPEUTIC USE a) Injection site pain was infrequently reported by children during clinical studies (USPDI , 2002; Prod Info Protropin(R), somatrem, 2001).
b) Rarely, an increased growth of pre-existing nevi has been reported (USPDI , 2002; Prod Info Protropin(R), somatrem, 2001).
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Musculoskeletal |
3.15.2) CLINICAL EFFECTS
A) MYOSITIS 1) WITH THERAPEUTIC USE a) CASE SERIES- Mild inflammatory myositis, with myalgia and muscle weakness has been reported in 2 patients following growth hormone therapy. The authors suggested that myositis might be due to m-cresol used as a preservative in the preparation (Yordam, 1994).
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Endocrine |
3.16.2) CLINICAL EFFECTS
A) GYNECOMASTIA 1) WITH THERAPEUTIC USE a) Gynecomastia has rarely been reported with the use of somatrem (S Sweetman , 2002; USPDI , 2002; Prod Info Protropin(R), somatrem, 2001).
b) CASE SERIES - Prepubertal gynecomastia was reported in 22 patients during growth hormone therapy (Malozowski & Stadel, 2001).
B) HYPOTHYROIDISM 1) WITH THERAPEUTIC USE a) Reversible hypothyroidism has been reported in children treated with growth hormone (USPDI , 2002; Prod Info Protropin(R), somatrem, 2001; Lippe et al, 1975; Ranke et al, 1979).
C) HYPERGLYCEMIA 1) WITH THERAPEUTIC USE a) Somatrem may increase insulin resistance (S Sweetman , 2002; USPDI , 2002; Prod Info Protropin(R), somatrem, 2001).
b) CASE REPORT - Nonketotic hyperglycemia developed in a 22-month-old child within weeks of beginning growth hormone therapy. In addition, she developed seizures and metabolic acidosis; the patient died despite symptomatic treatment (Garg, 1994).
D) HYPOGLYCEMIA 1) WITH THERAPEUTIC USE a) High acute dosage of somatrem has been associated with hypoglycemia (S Sweetman , 2002).
E) EMPTY SELLA SYNDROME 1) CASE REPORT - Pituitary atrophy (partial empty sella syndrome) has been reported in an athlete with a long history of abuse of exogenous growth hormone, testosterone and thyroid hormone (Dickerman & Jaikumar, 2001).
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Immunologic |
3.19.2) CLINICAL EFFECTS
A) ACUTE ALLERGIC REACTION 1) WITH THERAPEUTIC USE a) Allergic reaction may occur with somatrem use (Prod Info Protropin(R), somatrem, 2001).
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Reproductive |
3.20.1) SUMMARY
A) Somatrem is in FDA pregnancy category C. It is not known if somatrem is excreted into human breast milk
3.20.3) EFFECTS IN PREGNANCY
A) PREGNANCY CATEGORY 1) U.S. Food & Drug Administration's Pregnancy Category C (Prod Info Protropin(R), somatrem, 2001).
3.20.4) EFFECTS DURING BREAST-FEEDING
A) BREAST MILK 1) It is not known if somatrem is excreted into human breast milk (Prod Info Protropin(R), somatrem, 2001).
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Carcinogenicity |
3.21.3) HUMAN STUDIES
A) LEUKEMIA 1) WITH THERAPEUTIC USE a) Growth hormone use has been associated with the development of leukemia, however, a causal relationship is not clear (Prod Info Protropin(R), somatrem, 2001; Stahnke & Zeisel, 1989; Sartorio et al, 1989; Anon, 1988; Watanabe et al, 1988).
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