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It has not been evaluated by bodies like the United States Food and Drug Administration (FDA) or comparable international agencies, leading to a significant gap in understanding its safety for human use

Mass compounders and supposed personalizers seeking to circumvent the law are also mixing tirzepatide with glycine, pyridoxine, niacinamide, carnitine, or other chemicals, creating a range of new and untested combination drugs, the company stated in its warning Thursday

According to a TGA spokesperson, its development as a potential medicine was halted some years ago due to safety reasons. And yet, some Australians continue to use Melanotan-II for tanning, despite continued warnings from the TGA