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[IPp] Re: insulin in pumps

Tea -

  <<I went to a new Dr. for my girls and he wants me to switch from 
Humolog to
Novalog. He said it was better. Other than their made by different 
What is the differences? Is one better than the other? What does 
everyone use in
their pumps?>>

One reason your doctor may have recommended Novolog is that it's the 
only insulin which has been FDA-approved for use in pumps.  What this 
means is - Novo-Nordisk did well-controlled clinical trials using 
Novolog in pumps, and the FDA agreed that the results show that Novolog 
is safe and effective for use in pumps (in adults; apparently they 
didn't test in children).

This is not to say that Humalog isn't safe or effective - in fact most 
pumpers do use Humalog - but Lilly apparently hasn't done the clinical 
trials to PROVE that it's safe and effective when used in pumps 
(although they have proven that it is safe and effective for use as a 
shot).  Personally, I use Humalog for my daughter because we dilute her 
insulin, and Lilly makes diluent to go with Humalog, while Novo-Nordisk 
doesn't make diluent to go with Novolog.

If you ever have a question about what the FDA-approved uses of a drug 
actually are, read the label, and read that little piece of paper that 
is stuffed into the package when you buy the drug (yes, insulin is 
technically a drug).  Every word on that label, and on that package 
insert, has been cleared by the FDA.

On the flip side - if a drug isn't FDA-approved for a particular use, 
that doesn't necessarily mean it won't work.  What it means is that the 
FDA hasn't yet seen proof that the drug is safe and effective for that 
use.  By "proof" I mean well-controlled clinical trials.  The real-life 
experience of thousands of "off-label" users (not in trials) isn't 
enough (by itself) to get FDA approval for that use.  Since clinical 
trials are very expensive, often manufacturers will do enough trials to 
prove that their drug is safe and effective for *something*, but not 
enough to prove that the drug is safe and effective for every possible 
way it could be used.  Note that you only need to prove that a drug is 
good for one kind of use, in order to get permission to sell it in the 
US.  It can however be prescribed for anything a doctor sees as 
appropriate, once it is approved for sale.

The FDA is actually working very hard to be more consumer-friendly, and 
there is a lot of information on their website, including information 
about diabetes:


Maria Oyaski
Regulatory Affairs Specialist
and pumpmama to Sigrid, 2  yo last week
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