Growth hormone biopharmaceuticals, originally prescribed to patients with growth hormone deficiency, such as Turner syndrome, are being prescribed recklessly under the guise of “height growth injections,” a lawmaker pointed out on Wednesday.
However, the Ministry of Food and Drug Safety (MFDS) said that the safety and efficacy of these drugs have not been confirmed for height growth in the general population.
According to data submitted by the MFDS and related organizations to Rep. Kim Young-joo of the Democratic Party of Korea, 10.66 million growth hormone injections were supplied to 5,761 medical institutions nationwide from 2021 to this past September. Only 307,000, or 3 percent of the total, were prescribed to 32,698 patients with short stature with health insurance coverage.
The remaining 10.35 million injections, 97 percent, were prescribed without health insurance coverage for the height growth of healthy children and adolescents.
Twenty-four growth hormone biopharmaceuticals are now prescribed in medical institutions, covered by health insurance benefits for patients with short stature, including Turner syndrome, hypopituitarism (pediatric growth hormone deficiency, adult growth hormone deficiency), and congenital anomalies associated with short stature (Prader-Willi syndrome and Noonan syndrome). During the period, there were 78,218 low-height-related patients in Korea.
However, it has been pointed out that growth hormone injections are being prescribed for children and adolescents at university hospitals, hospitals, and growth clinics in Korea, even though the safety and efficacy of so-called “growth injections” for children and adolescents who are not short stature patients have not been confirmed.
"Clinical trials were conducted only for patients with growth hormone deficiency, including Turner syndrome, and there were no clinical trials for the general population,” the ministry said in its official response. “It has not been confirmed whether the biopharmaceutical is effective for the general population (such as pediatric patients)."
Besides, a study conducted by the National Evidence-based Healthcare Collaborating Agency (NECA) concluded that using growth hormone beyond the licensed range lacks scientific evidence, so it is not recommended to prescribe it to the general population for short stature outside of clinical studies.
Most of these medications are prescribed by healthcare providers and administered by parents or children at home six to seven times a week. A month's worth of medication costs between 500,000 won and 850,000 won ($370-$635) at a tertiary general hospital. More than 10 million won is spent on growth hormone injections in a year.
Rep. Kim pointed out that all of the biopharmaceuticals prescribed on the market for height growth have no confirmed efficacy or effectiveness, but they are being misused as if they were helpful for height growth.
"The problem of hospitals advertising and prescribing growth hormone biopharmaceuticals that have never been clinically tested on the general public as if they were effective for growing children and adolescents is serious," the opposition lawmaker said. "The Ministry of Health and Welfare and the Ministry of Food and Drug Safety should take steps to manage and supervise the misuse of biopharmaceuticals different from the purpose of their initial approval."