ADVERSE REACTIONS
As with all protein pharmaceuticals, a small percentage of patients may develop antibodies to the protein. GH antibody binding capacities below 2 mg/L have not been associated with growth attenuation. In some cases when binding capacity exceeds 2 mg/L, growth attenuation has been observed. In clinical studies of pediatric patients that were treated with Nutropin for the first time, 0/107 growth hormone-deficient (GHD) patients, 0/125 CRI patients, 0/112 Turner syndrome patients, screened for antibody production developed antibodies with binding capacities >/=2 mg/L at six months.
Additional short-term immunologic and renal function studies were carried out in a group of patients with chronic renal insufficiency after approximately one year of treatment to detect other potential adverse effects of antibodies to GH. Testing included measurements of C1q, C3, C4, rheumatoid factor, creatinine, creatinine clearance, and BUN. No adverse effects of GH antibodies were noted.
In addition to an evaluation of compliance with the prescribed treatment program and thyroid status, testing for antibodies to GH should be carried out in any patient who fails to respond to therapy.
In studies in patients treated with Nutropin, injection site pain was reported infrequently.
Leukemia has been reported in a small number of GHD patients treated with GH. It is uncertain whether this increased risk is related to the pathology of GH deficiency itself, GH therapy, or other associated treatments such as radiation therapy for intracranial tumors. On the basis of current evidence, experts cannot conclude that GH therapy is responsible for these occurrences. The risk to GHD, CRI, or Turner syndrome patients, if any, remains to be established.
Other adverse drug reactions that have been reported in GH-treated patients include the following: 1) Metabolic: mild, transient peripheral edema. In GHD adults, edema or peripheral edema was reported in 41% of GH-treated patients and 25% of placebo-treated patients; 2) Musculoskeletal: arthralgias; carpal tunnel syndrome. In GHD adults, arthralgias and other joint disorders were reported in 27% of GH-treated patients and 15% of placebo-treated patients; 3) Skin: rare increased growth of pre-existing nevi; patients should be monitored for malignant transformation; and 4) Endocrine: gynecomastia. Rare pancreatitis.
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REPORTS OF SUSPECTED NUTROPIN SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Nutropin. The information is not vetted and should not be considered as verified clinical evidence.
Possible Nutropin side effects / adverse reactions in 17 year old male
Reported by a pharmacist from United States on 2011-12-08
Patient: 17 year old male weighing 50.0 kg (110.0 pounds)
Reactions: Arthralgia, Gait Disturbance
Suspect drug(s):
Nutropin
Dosage: 2 mg daily sc
Indication: Body Height Below Normal
Start date: 2011-01-25
End date: 2011-02-06
Nutropin
Dosage: 2 mg daily sc
Indication: Growth Hormone Deficiency
Start date: 2011-01-25
End date: 2011-02-06
Possible Nutropin side effects / adverse reactions in 20 month old male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-19
Patient: 20 month old male
Reactions: Cryptorchism, Orchidopexy
Adverse event resulted in: hospitalization
Suspect drug(s):
Nutropin
Other drugs received by patient: Synthroid; Hydrocortisone
Possible Nutropin side effects / adverse reactions in 57 year old female
Reported by a physician from Netherlands on 2012-05-25
Patient: 57 year old female weighing 60.0 kg (132.0 pounds)
Reactions: Adenocarcinoma
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Nutropin
Other drugs received by patient: Hydrocortisone; Duphaston; Alendronic Acid; Atrovent; Dermestril ^opfermann^; Femoston ^eurimpharm^
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