FDA announces ongoing safety review of recombinant human growth hormone and possible increased risk of death

February 1, 2011

FDA released a safety communication to inform prescribers and patients about a possible increased risk of death in persons with certain kinds of short stature treated with recombinant human growth hormone (also known as somatropin).

Key Points

FDA released a safety communication to inform prescribers and patients about a possible increased risk of death in persons with certain kinds of short stature treated with recombinant human growth hormone (also known as somatropin). Both FDA and the European Medicines Agency have initiated a safety review of this class of medications.

These ongoing safety reviews and FDA communication are the result of recently released data from the Santé Adulte GH Enfant (SAGhE) study.

Recombinant human growth hormone (marketed in the United States as Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin) is a protein nearly identical to that found naturally in the human body. Whether naturally occurring or recombinant, human growth hormone stimulates tissue growth, height, and metabolism of protein, carbohydrate, lipid, and minerals. It has approved indications for both the adult and pediatric populations.

SAGhE is a long-term epidemiological study designed to assess the long-term mortality of French patients treated with recombinant human growth hormone during childhood between 1985 and 1996. The researchers responsible for conducting this study have recently reported a 30% increased risk of death with recombinant human growth hormone therapy compared to the general population of France (93 observed deaths in the treated group versus 70 expected deaths in the general population), according to a press release. Data suggest the increase in mortality was likely due to excess deaths resulting from bone tumors, cardiovascular, and cerebrovascular events.

Moreover, data from the SAGhE study suggested that the excess death rate seemed greatest in those receiving doses of recombinant growth hormone higher than that normally prescribed for pediatric growth hormone deficiency. Typically doses <50 μg/kg/day are prescribed to treat growth hormone deficiency, except during puberty, when a higher dose regimen is approved for a limited duration of time. Indications other than growth hormone deficiency use doses as high as 69 μg/kg/day.

Despite these uncertainties, FDA is recommending that patients continue their recombinant human growth hormone treatment as prescribed by their healthcare provider. According to Agency officials, "FDA is currently reviewing all available new information on this potential risk and at this time, recommends caution when interpreting the reported results." They continued by emphasizing, "FDA believes the benefits of recombinant growth hormone continue to outweigh the potential risks."

The SAGhE study is funded by the European Commission and conducted by a European consortium of pediatric endocrinologists, epidemiologists, and biostatisticians. The study is still ongoing and further results are expected in the future.

SOURCES

FDA. FDA Drug Safety Communication: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death [12-22-2010]. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm237773.htm. Accessed January 6, 2011.

European Medicines Agency. Update on somatropin-containing medicines: Review of somatropin officially started [12-16-10]. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/12/news_detail_001167.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1&jsenabled=true. Accessed January 6, 2011.

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