Patients given recombinant growth hormones could face a higher risk of death from bone tumors and brain hemorrhages, federal drug safety investigators are warning.
The FDA issued a drug safety communication on December 22, 2010, indicating that French researchers found patients given the hormones, designed to increase stature in people who suffer a hormone deficiency that has stunted their growth, were at a 30% increased risk of death over those not given the hormone treatments.
The risk of death was highest when the injections exceeded the amount of growth hormones normally prescribed to treat pediatric growth hormone deficiency, the FDA noted.
Recombinant human growth hormones (somatropin) are synthetic proteins designed to emulate naturally-occurring human growth hormones. They stimulate tissue growth, can increase height and boost the body’s metabolism when dealing with proteins, carbohydrates, lipids and minerals. It is approved for use in both adults and children and goes by a number of brand names in the U.S., including Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen and Tev-Tropin.
Researchers in France conducted a study known as the Santé Adulte GH Enfant (SAGhE) study, which looked at the long-term epidemiological effects of the hormone injections and the mortality of patients given the drug. There was a 30% increased risk of death when patients given somatropin therapy were compared to the rest of the population, particularly when doses exceeded typical pediatric use. The increased mortality appears to be caused by bone tumors and cardiovascular diseases, as well as cerebrovascular events.
In the United States, somatropin is usually given in doses below 50 mcg/kg/day, with the exception of patients in puberty, who can be given doses as high as 69 mcg/kg/day.
The FDA said it is continuing to review and analyze all of the data and will communicate its findings with the public. In the meantime, drug safety officials say that the actual risk increase is fairly small and the agency believes that the health benefits of the drugs continue to outweight the risks.
The FDA recommends that patients do not stop taking recombinant human growth hormones unless they have talked to a health care professional. The agency also asks both health care providers and patients to report any adverse events to the FDA MedWatch program at www.fda.gov/MedWatch/report.htm.