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EMA confirms safety profile for growth hormone

Regulator investigated somatropin-containing medicines after study raised mortality fears

The European Medicines Agency (EMA) has said that somatropin-containing medicines are still okay to use, despite fears of an increased risk of mortality.

Medicines that contain the growth hormone are used to treat growth failure, growth hormone deficiency, intestinal disorder or HIV-related weight loss or wasting and current brands on the market include Pfizer's Genotropin and Lilly's Humatrope.

The agency's scientific advisors said medications containing somatropin had a positive risk-benefit balance, noting there were 'significant methodological limitations' in the epidemiological study that first raised concerns.

This was the on-going French study - Santé Adulte GH Enfant (SAGE) - of more than 10,000 young adults who started a recombinant growth hormone treatment between 1985 and 1996. It had suggested a possible increase in death rates due to incidences of bone tumours and subarachnoid or intracerebral haemorrhage following somatropin treatment.

At the request of the French medicines regulatory agency, the EMA initiated further review of the hormone in December 2010, including data from clinical trials, registries, cohorts and reports of side effects.

The EMA's Committee for Medicinal Products for Human Use (CHMP) found that this data did not substantiate claims of a potentially higher risk of mortality associated with somatropin.

Despite the confirmation of the safety profile, the CHMP advised prescribers to “strictly follow the approved indications and doses and to carefully consider the warnings and precautions for somatropin-containing medicines”.

These includes a recommendation that somatropin must not be used if there is any evidence of a tumour activity.

The CHMP also noted that the available data on the long-term effects of somatropin treatment are very limited. Further mortality data from the SAGE study will be available by the end of 2012, and the CHMP is due to analyse these results to address remaining concerns.

16th December 2011

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