Safety Of Recombinant Human Growth Hormone (somatropin) And Possible Increased Risk Of Death
A number of months ago (September, 8, 2011) I wrote an entry about risks vs. benefits in treating medical disorders. I used as an example the “story” about diethylstilberterol or DES which was used to treat women to prevent miscarriages and was years later found to cause vaginal carcinoma in daughters of these women. The moral of the story was that the risks, including unknown risks must be worth the potential benefit of the treatment whatever the condition. Here we go again- this time it’s about growth hormone. 12/22/2010, the FDA issued a Drug Safety Communication entitled ” Ongoing safety review of Recombinant Human Growth Hormone (somatotropin) and possible increased risk of death.” (www.fda.gov/Drugs/DrugSafety/ucm237773.htm.htm). The FDA announced that a study conducted in France called the Sante Adulte GH Enfant (SAGhE) study, found that some patients treated with growth hormone injections for diagnoses of idiopathic short stature, idiopathic growth hormone deficiency, and gestational short stature (intrauterine growth retardation) showed increased risk of death compared to individuals in the general population of France. At the time, the U.S. Pediatric Endocrine Society notified all members about the study and emphasized that the study results were only preliminary and that more data would follow. Pediatric endocrinologists were urged to continue to treat their patients with growth hormone injections as before, pending further study results. 08/04/2011, the FDA issued an update (www.fda.gov/Drugs/DrugSafety/ucm265865.htm) that it was reviewing the SAGhE study and had found some potential flaws in the study design but that further data were expected in the Spring 0f 2012 and that health care professionals should continue to prescribe and use recombinant growth hormone according to the labeled recommendations.
What’s the latest?
Just today, I got a memo from the Pediatric Endocrine Society that the SAGhE study results had been published along with 3 editorials/commentaries about the study. I want to call the study results and the editorials and commentaries to your attention. The bottom line from the study data is that mortality rates were increased about 30% in adults who had been treated with recombinant growth hormone as children. The study population included almost 7000 subjects who started treatment between 1985-1996. The increased mortality was mostly related to cardiovascular and bone tumor causes. The investigators stressed the need for additional studies of long-term mortality and morbidity after growth hormone treatment in childhood. The editorials/commentaries were written by noted authorities in the U.S. and Europe and generally supported the need for further studies and basically recommended one of two approaches- either, be careful to make certain that until more data were available that patient selection for growth hormone treatment include a careful risk/benefit assessment, or, full speed ahead while we await more data. I will offer no comment regarding which of the two “camps” I am in. It’s all pretty creepy. I do remember that when the first cases of vaginal cancer in daughters of DES-treated mothers were reported and when the first case of Creutzfeld-Jacob disease in a young adult treated with cadaveric human growth hormone surfaced, many “experts” were not much impressed with the preliminary data. I hope it’s not those stories all over again, but this time about recombinant human growth hormone. No matter what the study shows when all the dust clears, we as health care professionals must not forget that even unknown risks must be factored into risk/benefit assessments no matter what the condition.
Carel J-C, et al: Long-term mortality after recombinant growth hormone deficiency or childhood short stature: preliminary report of the French SAGhE Study. J Clin Endocrinol Metab 2012;97:416-25 (February 1, 2012).
Sperling MA. Editorial:Long-term therapy with growth hormone: bringing sagacity to SAGhE. J Clin Endocrinol Metab 2012;97:81-3.
Rosenfeld RG, et al. Commentary: Long-term surveillance of growth hormone therapy. J Clin Endocrinol Metab 2012;97:68-72.
Malozowski S. Editorial: Reports of increased mortality and GH: will this affect current practice? J Clin Endocrinol Metab. 2012;97:380-83.
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