Does growth hormone need preservatives?

 KNOWLEDGE    |      2023-03-28

The commonly used medical preservatives of growth hormone are phenol, cresol and so on. Phenol is a common pharmaceutical preservative. A study by the United States Environmental Protection Agency (EPA) indicated that exposure to phenol may cause fetal developmental retardation. There have been cases of hospital use of phenol disinfectants resulting in outbreaks of infant hypobilirubinemia and some fetal death, so phenol is considered toxic to infants or fetuses.

Because of the toxicity of phenol, FDA, EU and China have strictly regulated the upper limit of the addition of preservatives. FDA stipulates that the concentration of phenol should be controlled within 0.3%, but FDA also explains that serious adverse reactions have been reported in some patients even at the permitted concentration, and long-term use should be avoided. Continuous intake of permitted low doses should also be avoided for more than 120 days. That is to say, although the concentration of phenol added to growth hormone is very low, its adverse reactions often occur after long-term use, and even the cases leading to disease can be found everywhere. After all, preservatives are bacteriostatic by their toxicity, and if the toxicity is too low, the purpose of bacteriostatic is not effective.

Due to the high technical requirements of growth hormone water agent, most growth hormone water agent manufacturers can only add preservatives to ensure that growth hormone does not deteriorate due to the limited production technology, but long-term injection of preservatives will bring potential toxic damage to children's central nervous system, liver, kidney and other body organs. Therefore, for patients with long-term use of growth hormone, growth hormone without preservatives should be selected as far as possible, so as to effectively avoid the toxic side effects of preservatives and make long-term use safer for children.