The EMA has confirmed the benefit-risk of somatropin-containing medicines remains positive following a review by its Committee for Medicinal Products for Human Use.
A review was initiated in December 2010 after results from a long-term epidemiological study in patients treated with somatropin-containing medicines suggested a possibly increased risk of mortality.
The CHMP concluded that the study had significant methodological limitations and other examined data did not demonstrate a higher risk of mortality.
However, it has reminded prescribers to “strictly follow the approved indications and doses and to carefully consider the warnings and precautions for somatropin-containing medicines” in the future.
Somatropin is a human growth hormone manufactured using recombinant DNA technology. It aims to increase growth during childhood and adolescence and also affects the way the body deals with proteins, fat and carbohydrates.
The medicines are used to treat a number of conditions in children who fail to grow adequately due to a lack of growth hormone, Turner syndrome or chronic renal insufficiency and short children born small for gestational age.
Concerns were raised after the initial results from the epidemiological study in patients treated with somatropin-containing medicines during childhood for idiopathic lack of growth hormone and idiopathic or gestational short stature suggested an increased risk of mortality due to bone tumours and subarachnoid or intracerebral haemorrhage.
In addition to the study, the CHMP also considered all available data on the safety of the medicines in its review, including information from clinical trials, registries, cohorts and from spontaneous reports of side-effects when assessing the benefit-risk balance of the medications.
After analysing all of the data, the CHMP considered the benefit-risk balance remains positive in the approved indications and doses.
In doing so, the Committee also took the opportunity to harmonise the existing contraindications, warnings and precautions for somatropin-containing medicines throughout the EU. The harmonised wording emphasises that somatropin must not be used if there is evidence of a tumour and that recommended daily doses should not be exceeded.
The Committee says it will continue to review any new “important data” on the safety of the medicines that may emerge in the future.