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.

About the Author

Tom D'Amore is the founder of D'Amore Law Group and a trial attorney with over 30 years of experience representing injured people and their families across the West Coast, securing more than $325 million in recoveries. He handles cases involving car accidents, trucking accidents, construction injuries, medical malpractice, and sexual abuse. Licensed in Oregon, Washington, and California, Tom is the only NBTA board-certified truck accident attorney in Oregon. He is a national Board of Governors member, past Executive Committee member, and past Budget and Audit Chair of the American Association for Justice, as well as past President of the Oregon Trial Lawyers Association and an Eagle member of the Washington State Association for Justice.