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EMA reviewing somatropin safety

December 11, 2010 12:18 AM UTC

The European Medicines Agency will review the safety of products containing somatropin human growth hormone after a long-term epidemiological study suggested an increased risk of mortality with somatropin therapy compared to the general population. EMA acknowledged that the risk cannot be associated with somatropin with certainty based on the observational study alone. The study evaluated patients treated during childhood for growth hormone deficiency or short stature of unknown cause. EMA plans to provide additional information after its CHMP meeting on Dec. 13-16. ...