FDA Alert - Ongoing Safety Review: Recombinant Human Growth Hormone (somatropin) - Possible Increased Risk of Death

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FDA MedWatch Alert Sent to subscribers of: somatropin systemic Ongoing Safety Review: Recombinant Human Growth Hormone (somatropin) - Possible Increased Risk of Death August 4, 2011 Audience: Pediatrics, Endocrinology. [UPDATED 08/04/2011] FDA has determined that, at this time, the evidence regarding recombinant human growth hormone and increased risk of death is inconclusive. In its analysis of the SAGhE study, FDA identified a number of study design weaknesses that limit the interpretability of the study results. FDA also reviewed the medical literature, as well as reports from the Agency's Adverse Event Reporting System (AERS). These additional data sources did not provide evidence suggestive of a link between recombinant human growth hormone and an increased risk of death. Read more... Get these updates via twitter

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