Why do medication labels say “for ages 12 years and older”

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Pretty much the title but why is it always consistently 12 years of age across the board? What makes a 12 year old suddenly be able to take these medications? (BTW I know you can talk to your doctor to see if it’s okay for younger children to take them as well and that some medications can be taken by children under the age of 12)

In: Biology

3 Answers

Anonymous 0 Comments

Medical research is neither legal nor ethical unless you have the informed consent of the research subject. This requirement makes research on children more difficult, and as a result, more expensive. Drug companies won’t test on children unless there’s a good reason (like making a version of the drug targeted specifically at kids).

Medicine in the US cannot make claims about its effect unless there are studies that back it up[1]. So, if you haven’t paid to run a study on ten-year-olds, then you can’t claim the medicine is safe for ten-year-olds. Doctors will prescribe it if there’s no alternatives, but it’s technically untested (this is considered an issue).

I have not been able to find a hard-and-fast rule about the age of consent for medical research. It seems that it varies by state. I’m guessing that either 12 is either a common threshold that warrants extra legal protection, or there’s one state that goes that low and that’s where all the research is done.

[1] FUN FACT: You know that dumb, stupid commercial “Head On: Apply Directly to the Forehead”? There’s a reason why the ad went like that. They originally had a full script for a normal commercial. The FDA rejected *literally every other line* for being unsubstantiated medical claims. That one line was not a medical claim, so it was approved. The company decided to go forward with what they had.

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