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[IP] Humalog and pregnancy

The FDA has 4 categories for pregnancy (A through D), and when a drug is
approved, the company must show their research to justify the pregnancy
    A= safe and effective for use in human pregnancy
    B= not tested in human pregnancy, but no evidence of problems in animal
    C= not tested in human pregnancy, and evidence of birth defects in
animal pregnancies
    D= known risk of birth defects in human pregnancies
 Unfortunately, it is more costly and risky to get a pregnancy indication
for humans, so a lot of companies don't even do the research or ask for the
indication.  The FDA is beginning to insist that the companies do the
research for kids, if there is a high likelihood that they would benefit
from the product.  I don't think they're cracking down on pregnancy yet.  Of
course, a licensed physician can use any drug they want for any reason they
want, then the legal burden is on the doctor.  So there are lots of products
used "off indication", or for reasons that the drug company doesn't have FDA
blessings.  Humalog has a Pregnancy Category B - Lilly just didn't do the
research that it took to get the A category.  If you have a chance, write to
Lily and encourage them to do the research for pregnancy and children.

Nancy Morgan, Jenna's mom, who happens to be a family physician when she
isn't being Jenna's mom

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