The European Medicines Agency (EMA) has finalised its review of somatropin-containing medicines, and confirmed that the benefit-risk balance of these medicines remains positive. However, the prescribers are reminded to strictly follow the approved indications and doses and to carefully consider the warnings and precautions for somatropin-containing medicines.

This review was initiated in December 2010 following concerns raised in a long-term epidemiological study in patients treated with somatropin-containing medicines during childhood for idiopathic lack of growth hormone and idiopathic or gestational short stature. The study suggested a possibly increased risk of mortality with somatropin therapy compared with the general population. In particular, an increased risk of mortality due to bone tumours and subarachnoid or intracerebral haemorrhage. A review by the Agency’s advisory committee noted that the study had significant methodological limitations and that the other safety data examined did not corroborate a potentially higher risk of mortality associated with somatropin-containing medicines.

The Committee also took the opportunity of this review to harmonise the existing contraindications, warnings and precautions for these medicines throughout the EU. The harmonised wording emphasises that somatropin must not be used if there is any evidence of a tumour activity, and that the recommended maximum daily dose should not be exceeded.