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For new medicines, the manufacturer then has to recruit children and newborns into trials (unless the medicine is not going to be used in children and newborns) and subsequently amend the PIL with the approved information. Older medicines may have been used effectively for many years in children without problems but the manufacturer has not been required to collect data and amend the licence. This does not mean that it is unsafe for children and young people to be prescribed such a medicine ‘off-licence/off-label’. However, if you are concerned about any conflicts of information, please discuss with your doctor, nurse or pharmacist.
Some of the approved drugs are synthetic versions of the natural hormones, such as trenbolone acetate and zeranol. Just like the natural hormone implants, before FDA approved these drugs, FDA required information and/or toxicological testing in laboratory animals to determine safe levels in the animal products that we eat (edible tissues). Furthermore, FDA required that the manufacturers demonstrate that the amount of hormone left in each edible tissue after treatment is below the appropriate safe level. As described above, a safe level is a level which would be expected to have no harmful effect in humans.