ADVERSE REACTIONS
Most Serious and/or Most Frequently Observed Adverse Reactions
This list presents the most seriousb and/or most frequently observeda adverse reactions during treatment with somatropin:
- bSudden death in pediatric patients with Prader-Willi syndrome with risk factors including severe obesity, history of upper airway obstruction or sleep apnea and unidentified respiratory infection [see CONTRAINDICATIONS ]
- bIntracranial tumors, in particular meningiomas, in teenagers/young adults treated with radiation to the head as children for a first neoplasm and somatropin [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS ]
- a,bGlucose intolerance including impaired glucose tolerance/impaired fasting glucose as well as overt diabetes mellitus [ WARNINGS AND PRECAUTIONS ]
- bIntracranial hypertension [see WARNINGS AND PRECAUTIONS ]
- bSignificant diabetic-retinopathy [see CONTRAINDICATIONS ]
- bSlipped capital femoral epiphysis in pediatric patients [see WARNINGS AND PRECAUTIONS ]
- bProgression of preexisting scoliosis in pediatric patients [see WARNINGS AND PRECAUTIONS ]
- aFluid retention manifested by edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paraesthesias [see WARNINGS AND PRECAUTIONS ]
- aUnmasking of latent central hypothyroidism [see WARNINGS AND PRECAUTIONS ]
- aInjection site reactions/rashes and lipoatrophy (as well as rare generalized hypersensitivity reactions) [see WARNINGS AND PRECAUTIONS ]
Clinical Trials Experience
Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin formulation cannot always be directly compared to the rates observed during the clinical trials performed with a second somatropin formulation, and may not reflect the adverse reaction rates observed in practice.
Clinical Trials in Pediatric GHD Patients
As with all protein drugs, a small percentage of patients may develop antibodies to the protein. GH antibodies with binding capacities lower than 2 mg/L have not been associated with growth attenuation. In a very small number of patients, when binding capacity was greater than 2 mg/L, interference with the growth response was observed.
The following events were observed during clinical studies with OMNITROPE® Cartridge conducted in children with GHD:
Table 1. Incidence of adverse reactions occurring in ≥ 5% pediatric patients with GHD during treatment with OMNITROPE® Cartridge (n=86) | Adverse Event | Number (%) |
| Elevated HbA1c | 14 |
| Eosinophilia | 12 |
| Hematoma | 9 |
The following events were observed during clinical studies with OMNITROPE® for injection conducted in children with GHD:
Table 2. Incidence of adverse reactions occurring in ≥ 5% pediatric patients with GHD during treatment with OMNITROPE® for injection (n=44) | Adverse Event | Number (%) |
| Hypothyroidism | 16% |
| Elevated HbA1c | 14% |
| Eosinophilia | 11% |
| Hematoma | 9% |
| Headache | 7% |
| Hypertriglyceridemia | 5% |
| Leg Pain | 5% |
Clinical Trials in Adult GHD Patients
In clinical trials with somatropin in GHD adults, the majority of the adverse events consisted of mild to moderate symptoms of fluid retention, including peripheral swelling, arthralgia, pain and stiffness of the extremities, peripheral edema, myalgia, paresthesia, and hypoesthesia. These events were reported early during therapy, and tended to be transient and/or responsive to dosage reduction.
Post-Marketing Surveillance
Because these adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The adverse events reported during post-marketing surveillance do not differ from those listed/discussed above in Sections 6.1 and 6.2 in children and adults.
Leukemia has been reported in a small number of GH deficient children treated with somatropin, somatrem (methionylated rhGH) and GH of pituitary origin. It is uncertain whether these cases of leukemia are related to GH therapy, the pathology of GHD itself, or other associated treatments such as radiation therapy. On the basis of current evidence, experts have not been able to conclude that GH therapy per se was responsible for these cases of leukemia. The risk for children with GHD, if any, remains to be established [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS ].
The following additional adverse reactions have been observed during the use of somatropin: headaches (children and adults), gynecomastia (children), and pancreatitis (children).
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REPORTS OF SUSPECTED OMNITROPE SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Omnitrope. The information is not vetted and should not be considered as verified clinical evidence.
Possible Omnitrope side effects / adverse reactions in 12 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-12
Patient: 12 year old male weighing 31.0 kg (68.2 pounds)
Reactions: Oedema Peripheral, Serum Sickness, Erythema Multiforme
Suspect drug(s):
Omnitrope
Other drugs received by patient: Omnitrope; Daytrana; Keflex
Possible Omnitrope side effects / adverse reactions in 1 month old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-01
Patient: 1 month old male weighing 4.0 kg (8.8 pounds)
Reactions: Eczema, Rash
Suspect drug(s):
Omnitrope
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