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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 |