Sermorelin Side Effects: Rare but Serious Adverse Events Explained

What the published safety record shows

The most detailed safety data come from a 1-year, open-label, multicenter trial in 110 previously untreated prepubertal children with growth hormone deficiency, 86 of them evaluable, given 30 micrograms/kg subcutaneously at bedtime [2]. Mean height velocity rose from 4.1 cm/year at baseline to 8.0 cm/year at 6 months and 7.2 cm/year at 12 months [2]. No adverse changes in general biochemical or hormonal analyses were noted, fasting glucose did not change, IGF-I was not excessively generated, and the drug was well tolerated overall [2].

Adult data are thinner. Ten older men with a mean age of 68 received both 0.5 mg and 1 mg subcutaneously twice daily, each for 14 days in random order, with a 14-day period without treatment between doses; it was a short physiology study, not a clinical-benefit trial [3]. Eleven healthy men aged 64 to 76 with low baseline IGF-I gave themselves 2 mg subcutaneously every night for 6 weeks; growth hormone release rose, while IGF-I did not change, and glucose, insulin and growth hormone responses to an oral glucose tolerance test did not change [10]. A pharmacokinetic study in 30 healthy men aged 19 to 43 measured growth hormone release after intravenous and intranasal dosing [1].

A review of sermorelin in children says single intravenous doses and repeated once-daily subcutaneous doses were well tolerated, and that transient facial flushing and pain at the injection site were the most commonly reported adverse events [5].

What FDA adverse event reports can show

Spontaneous reports to FDA cannot settle how often serious events occur: the agency states that the existence of a report does not establish that the drug caused the event, and that the information in these reports cannot be used to estimate how often the reported events occur [7].

Approval history

Geref's manufacturer discontinued the product in 2008 and asked FDA to withdraw the applications; FDA withdrew both approvals effective June 18, 2009, and in March 2013 determined that Geref was not withdrawn for reasons of safety or effectiveness [4][9]. Approved uses were childhood idiopathic growth hormone deficiency and a diagnostic test of pituitary growth hormone secretion, never adults, anti-aging, weight loss or athletic performance [4].

Sermorelin products in the US today are compounded, and compounded drugs are not FDA-approved: the agency does not review their safety, effectiveness or quality before they are marketed [6].