Zyprexa & Under 18
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Q:  Zyprexa & Under 18

Zyprexa is what the Doctor placed my ten-year-old son on. I read a flyer published by the makers of Zyprexa. It mentioned that no one under the age of 18 should be taking Zyprexa. This notice was from the manufacturer. I will bring this up with my son's doctor the next time I see him. However, how harmful could this medication be to a small child?

Below is the link to the leaflet http://www.lilly.co.uk/pdf/PIL%20-%20Zyprexa%205.pdf

Thank you in advance for your reply.

Dear Karen -- 
Your concern is understandable and it's good that you're reading labels like this very closely.  Let's see if I can help you with this "no one under 18" thing.  The first thing to know is that companies like the Zyprexa manufacturer are under very strict FDA (Food and Drug Administration) guidelines for how they market and label their products.  That's actually the reason for the line on the label that reads "Zyprexa is not for patients who are under 18 years."  This is because the research that has been done on Zyprexa was done on people older than 18.  

Unfortunately, we have very little direct research -- at least compared to research in adults -- on the use of medications like this in children.  That leaves doctors like your son's having to work with less direct research to guide them.  They use their knowledge of how the medication has worked in adults and combine it with their understanding of how kids can be different.  They generally use great caution giving any medication to children.  

But now the child/adolescent psychiatrists are getting a little more willing to use medications in children, and our experience in kids less than 10 is increasing.  In that respect you should know that it is not at all uncommon to use Zyprexa in a 10 year old, despite the label (which, again, is on the bottle because of federal regulations that relate to research performed).  

Finally, how harmful could this be to a 10 year old?  We have a moderate amount of experience answering that question in adults.  We know that Zyprexa has distinguished itself as probably the most effective "mood stabilizer", better for example than Depakote which is the common starting medication (along with lithium).  But, even more so than Depakote, Zyprexa can cause huge gains in weight.  So, it's an excellent medication, and it's a medication with some serious problems as well.  

How about in kids?  Ah, here's the same problem, you see?  We don't have the research in kids to answer that question.  We have accumulating experience, though.  So far, Zyprexa's benefits and problems look about the same in kids as they do in adults.  

Any medication, for an adult or a child, carries some risk.  A doctor tries to evaluate how much trouble a patient is having with their symptoms, and compare the risk of treating those symptoms with something like Zyprexa versus not treating at all.  If symptoms are severe enough, the risk of the medication -- even a somewhat unknown level of risk -- may be lower than the risk of not treating.  There is some evidence that treating early in bipolar disorder and other serious mental health problems can actually keep the illness from getting worse; depending on how seriously one takes that, it becomes easier to justify using a medication like Zyprexa in a 10 year old.  Here's an article, a little complex, but it talks directly about this issue of early intervention in kids.  

Here's a good site, BPKids, that has more information on this general area.  Try offering your concern on one of their message boards and see what you get.  Here's the medication board (scroll way down the page to find the current discussion threads...). 

Dr. Phelps 

Published December, 2002


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