A Drug & Medical Device Ongoing Safety Review Alert Has Been Issued: Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review – Possible Increased Risk of Death. According to the Food & Drug Administration FDA’s MedWatch:
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.
For more information on the drug or medical device recall or safety alert, read the Food & Drug Administration’s FDA’s drug or medical device recall or safety alert: Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review – Possible Increased Risk of Death.
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