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Regulators Question Safety of Growth Hormone After Study Shows Increased Risk of Death Among Adults Treated With Hormone as Children

As reported on MedPage Today, in early December, the European Medicines Agency (EMA) (the European Union's equivalent of the FDA) announced it will investigate the safety of growth hormone (known generically as somatropin) used to treat growth hormone deficiency and short stature in children

The review is based on data from a long-term study of about 7,000 patients who had received growth hormone treatments as children. The study suggested an increased risk of death among adults treated with growth hormone as children when compared to the general population. The mortality risk increased as the dosage received increased.

The EMA later clarified that while it would be pursuing a safety review of growth hormone, there was no immediate cause for concern.

The FDA has announced its own review. In the U.S., growth hormone is sold under brand names, including Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Serostim, and Tev-Tropin.

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