Jury Still Out on GROWTH HORMONE AND… Increased Risk for Death!
By Robert Lowes, from Medscape
August 5, 2011 – A safety review by the US Food and Drug Administration (FDA) has turned up no evidence so far linking recombinant human growth hormone – also known as somatropin (rDNA origin) injection – and a higher risk for death, the agency announced today.
In December 2010, the FDA announced that it was reviewing a French study and other available data on the possible increased risk for death with the agent.
The French study, called SantÃ© Adulte GH Enfant (SAGhE), found that persons with idiopathic growth hormone deficiency and idiopathic or gestational short stature who were treated with somatropin agents as children had a higher risk for death than the general French population.
(Short stature in children may result from a wide range of conditions, including growth hormone deficiency, Turner syndrome, Prader-Willi syndrome, chronic renal insufficiency, and children small for gestational age.)
“The data suggest an increase in mortality due to bone tumors and cardiovascular diseases including cerebrovascular events,” the FDA stated at the time.
The European Medicines Agency (EMA), the European equivalent of the FDA, also announced last December that it would launch a safety review of somatropin in light of the French study.
In today’s announcement, the FDA stated that it had spotted a number of design weaknesses in the SAGhE study that limit how the results can be interpreted. A review of the medical literature and reports from the agency’s own Adverse Event Reporting System also did not provide evidence linking recombinant human growth hormone therapy and an increased mortality risk. All in all, the evidence is “inconclusive.”
The FDA is advising clinicians to continue to prescribe somatropin agents, and for patients to continue using them. However, the agency stated that it is still reviewing the safety issue and awaiting additional information from the SAGhE study, which is expected in the spring of 2012.
A spokesperson for the EMA told Medscape Medical News that the agency’s safety review of recombinant human growth hormone therapy is ongoing. An EMA press release in May 2011 stated that the agency committee conducting the investigation “confirms that the benefit-risk balance of these medicines continues to be positive in their approved therapeutic indications and doses.”
Dr. Pinna says:
Many older men think that they can increase their muscle strength and also look younger by taking Growth Hormone. Human Growth Hormone is sold widely on the internet, although officially it is forbidden to be sold without a prescription. So many horny old men buy this illegal drug on the Internet.
Now we see from this report that using Growth Hormone has an increased risk of death.
In general, the FDA and other governmental agencies around the world, minimize the reported risk so that Big Pharma can continue to make profits even though they are killing people.
If some old man uses Growth Hormone to look younger, and (probably) to attract pretty young ladies, he may end up dead and in another universe where he is surrounded by all the other horny old men who did the same thing! With no pretty young ladies in sight!
Wouldn’t that be a Bummer!