European regulators have kicked off a safety review of medicines containing the growth drug somatropin, following new data indicating a potentially higher risk of death in patients who took the medicine.
The European Medicines Agency said it has received information from French authorities that a long-term epidemiological study in patients treated with somatropin-containing medicines for growth hormone deficiency or short stature during childhood suggest a higher risk of mortality versus the general population.
Moreover, the analysis of around 7,000 patients indicates that the risk “appears to be particularly increased when high doses are used”, i.e. those above what is recommended in the medicines’ summary of Product Characteristics, the agency said.
However, it did stress that these findings alone are not enough to conclude with any certainty that the risk is associated with this growth hormone therapy, and that further analysis must be carried out to confirm the observation.
Currently there are three somatropin-containing medicines centrally authorised in the European Union – Sandoz’ Omnitrope (the first biosimilar to be approved in Europe), BioPartner’s Valtropin and Ipsen’s NutropinAq – but several others, including products marketed by Pfizer (Genotropin) and Eli Lilly (Humatrope), have also been authorised via national channels throughout the region.
More information on the safety review will be provided following a Committee for Medicinal Products for Human Use meeting on December 13-16, the regulator noted.