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Recombinant Human Growth Hormone (somatropin):
Ongoing Safety Review - Possible Increased Risk of Death[Posted 12/22/2010]
AUDIENCE: Pediatrics, Endocrinology
ISSUE: FDA is informing the public that results from a study conducted in France — the Santé
Adulte GH Enfant (SAGhE) study — found that persons with certain kinds of short stature(idiopathic growth hormone deficiency and idiopathic or gestational short stature) treated withrecombinant human growth hormone during childhood and who were followed over a long periodof time, were at a small increased risk of death when compared to individuals in the general
population of France. FDA is currently reviewing all available information on this potential risk
and will communicate any new recommendations once it has completed its review.
BACKGROUND: Recombinant human growth hormone is a protein that is manufactured to benearly identical to the main form of the naturally occurring human growth hormone. Thishormone can stimulate tissue growth, linear growth (height), and protein, carbohydrate, lipid,and mineral metabolism. It has approved indications in both the adult and pediatric populations.
In the United States, recombinant human growth hormone is used in the pediatric population totreat short stature due to growth hormone deficiency (including idiopathic [of unknown cause]
growth hormone deficiency), Turner syndrome, Noonan syndrome, Prader-Willi syndrome, shortstature homeobox-containing gene (SHOX) deficiency, chronic renal insufficiency, idiopathic
short stature and children small for gestational age. Recombinant human growth hormone, also
known as somatropin [rDNA origin] injection, is marketed under the following brand names inthe United States: Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope,
Saizen, and Tev-Tropin.
RECOMMENDATION: Do not stop taking recombinant human growth hormone without talking
to your healthcare professional. At this time, FDA believes the benefits of recombinant growth
hormone continue to outweigh its potential risks.
Healthcare professionals and patients are encouraged to report adverse events or side effects
related to the use of these products to the FDA's MedWatch Safety Information and Adverse
Event Reporting Program:2000 Safety Alerts for Human
Medical Products

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and returnto the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178-[12/22/2010 - Drug Safety Communication - FDA]
    --Page Last Updated: 12/22/2010
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FDA Drug Safety Communication: Ongoing safety review ofRecombinant Human Growth Hormone (somatropin) andpossible increased risk of death

Safe Use Initiative

Information by Drug Class

Print this page[12-22-2010] The U.S. Food and Drug Administration (FDA) is informing the public that
results from a study conducted in France—the Santé Adulte GH Enfant (SAGhE) study—foundthat persons with certain kinds of short stature (idiopathic growth hormone deficiency andidiopathic or gestational short stature) treated with recombinant human growth hormone duringchildhood and who were followed over a long period of time, were at a small increased risk ofdeath when compared to individuals in the general population of France. FDA is currently
reviewing all available information on this potential risk and will communicate any newrecommendations once it has completed its review.
At this time, FDA recommends that patients continue their recombinant human growth hormone
treatment as prescribed by their healthcare provider.
Recombinant human growth hormone is a protein that is manufactured to be nearly identical tothe main form of the naturally occurring human growth hormone. This hormone can stimulate
tissue growth, linear growth (height), and protein, carbohydrate, lipid, and mineral metabolism.
It has approved indications in both the adult and pediatric populations. In the United States,
recombinant human growth hormone is used in the pediatric population to treat short stature
due to growth hormone deficiency (including idiopathic [of unknown cause] growth hormone
deficiency), Turner syndrome, Noonan syndrome, Prader-Willi syndrome, short stature
homeobox-containing gene (SHOX) deficiency, chronic renal insufficiency, idiopathic shortstature and children small for gestational age.
The SAGhE study is reported to be a long-term epidemiological study.1-3 It was designed toassess the long-term mortality of patients treated with recombinant human growth hormone
during childhood. The study population was based on a mandatory registry of patients in France
who received recombinant human growth hormone treatment during childhood between 1985
and 1996 and whose vital status and cause of death was determined through September 2009.
Recombinant human growth hormone, also known as somatropin [rDNA origin] injection, ismarketed under the following brand names in the United States: Genotropin, Humatrope,Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin.
(see Data Summary below)
Additional Information for Patients and Caregivers
Do not stop taking recombinant human growth hormone without talking to your healthcare
professional.
Discuss any questions or concerns about recombinant human growth hormone with yourhealthcare professional.
Report any side effects you experience to the FDA MedWatch program using the informationin the "Contact Us" box at the bottom of the page.
Additional Information for Healthcare Professionals
At this time, FDA believes the benefits of recombinant growth hormone continue to outweighits potential risks.
If you prescribe recombinant human growth hormone, follow the recommended indications
and doses in the product labels.
Report adverse events involving recombinant human growth hormone to the FDA MedWatch
program, using the information in the "Contact Us" box at the bottom of the page
Data Summary資料 4

FDA is aware of the results of a long-term epidemiological study called SAGhE (Santé Adulte GH
Enfant), which was designed to assess the long-term mortality of patients treated withrecombinant human growth hormone during childhood. 1-3 This study was based on a mandatory
registry of patients in France treated with recombinant growth hormone during childhood
between 1985 and 1996.
The investigators report a 30% increased risk of death with recombinant human growth
hormone therapy compared to the general population, with 93 observed deaths in the treatedgroup versus 70 expected deaths in the general population in France. The data suggest an
increase in mortality due to bone tumors and cardiovascular diseases including cerebrovascular
events (mainly subarachnoid or intracerebral hemorrhage).
The risk of death was reported to be increased when doses of recombinant growth hormone thatare higher than what is normally prescribed for pediatric growth hormone deficiency were used.
The approved doses in the United States for pediatric growth hormone deficiency are below 50
mcg/kg/day, except during puberty, when a higher dose regimen is approved for a limited
duration of time.For short stature indications other than growth hormone deficiency, doses up to69 mcg/kg/day (0.48 mg/kg/week) are currently approved.
In summary, the SAGhE study reported an increased risk of death in patients who were treatedwith recombinant human growth hormone during childhood when compared to individuals in thegeneral population of France. FDA is currently reviewing all available new information on thispotential risk and at this time, recommends caution when interpreting the reported results.
Additionally, FDA believes the benefits of recombinant growth hormone continue to outweigh thepotential risks. Patients should continue to follow the advice of their healthcare provider. FDA
will communicate with the public as soon as we have completed our evaluation. Furtherinformation is available in the European Medicines Agency (EMA) press releases1,3 and theAgence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) press release (inFrench).2
1. European Medicines Agency to review the safety of somatropin-containing medicines.
December 10, 2010 (press release). Accessed on December 13, 2010
2. Recombinant growth hormone (recombinant somatropin); first results of the long-term
epidemiological study SAGhE. Agence Francaise de Securite Sanitaire des Produits deSante, December 10, 2010 (press release). Accessed on December 13, 2010.
3. European Medicines Agency. Update on somatropin-containing medicines; Review ofsomatropin officially started. December 16, 2010 (press release). Accessed on December
18, 2010.
    -Related Information
European Medicines Agency to review the safety of somatropin-containing medicines.
December 10, 2010
Recombinant growth hormone (recombinant somatropin); first results of the long-term
epidemiological study SAGhE. Agence Francaise de Securite Sanitaire des Produits deSante, December 10, 2010
European Medicines Agency. Update on somatropin-containing medicines; Review ofsomatropin officially started. December 16, 2010
Somatropin Information-Contact Us
Report a Serious Problem
1-800-332-1088
1-800-FDA-0178 Fax
MedWatch Online
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20857---Page Last Updated: 12/22/2010
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HomeAbout FDA

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資料 4
Combination Products Advisory Committees Science & Research Regulatory Information Safety
News & Events Training and Continuing Education Inspections/Compliance State & Local Officials---Emergency Preparedness International Programs
Consumers Industry Health Professionals