[IP] RE: Humalog- was Joel Krueger
Recent posts said:
> I read that it hadn't been approved for use in a pump but that is a
> technical matter and it may have been on a website that
> wasn't updated. I'm
> sure Lilly would know but it's still a technical matter
> because it's been
> used for quite some time.
Once again, FDA approval has nothing to do with whether or not it may be
used in a pump. It means only that the manufacturer cannot market the
product for that use. FDA does not regulate the *use* of prescription
(with a few exceptions).
Close but not quite. It is true that once a drug (and insulin is
considered a drug) is approved by the FDA for one type of medical use,
it is legal for any physician to prescribe that drug for anything they
please (with a few exceptions for a few specific drugs). However,
the drug was approved because the FDA determined that the drug was SAFE
and EFFECTIVE for one particular use (based on a LOT of documentation
of a LOT of research presented by the manufacturer). Approval for one
use doesn't mean that the drug is safe and effective for everything
else under the sun! When a drug is not FDA-approved for a particular
use, it hasn't been proven safe and effective for that use, which
usually means that the manufacturer didn't even try to prove the point
- research is expensive, after all.
Novolog is FDA-approved for pump use, but Humalog is not. This means
that Novolog has been proven safe and effective for use in pumps. It
also means that Lilly hasn't proven to the FDA that Humalog is safe and
effective for use in pumps. Admittedly, a heck of a lot of people (my
daughter included) are alive today because they are using Humalog in
their pumps. So you'd think it would be a no-brainer for Lilly to just
PROVE that Humalog works for pumps, and apply for FDA approval for this
use. But they haven't done this. Unfortunately, this forces Humalog
pumpers to play a guessing game - how long can it last in the pump?
How about on a hot day? And we have to do the experiments on ourselves
and our children, ad hoc, because Lilly hasn't done the work (at least,
not that we can tell). I actually called Lilly recently and the
technical rep told me that they don't recommend using the insulin over
86 degrees F. Well, does this mean they've tested it above 86 and it
went bad, or does it just mean they never tested it above 86? No way
to tell, unfortunately.
However, right now Lilly has diluent that is approved for use with
Humalog (and the diluent is free!), but Novolog doesn't have diluent.
So, we would be using an unapproved something either way. Probably
both are perfectly fine, but gosh I wish the manufacturers had
well-controlled research to prove it to me. Unfortunately, this is the
case with a LOT of pediatric medicine - last I heard, at least half of
the drugs used for children have never been tested in children (with
the result that every child using these "untested" drugs is, in fact, a
pumpmom to Sigrid 19m.o.
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