[Previous Months][Date Index][Thread Index][Join - Register][Login]   Help@Insulin-Pumpers.org
  [Message Prev][Message Next][Thread Prev][Thread Next]   for subscribe/unsubscribe assistance

[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 
guinea pig.....).

pumpmom to Sigrid 19m.o.
for HELP or to subscribe/unsubscribe, contact: