My son was diagnosed with type 1 diabetes about three months ago, and I just found out that this insulin (NovoLog) which the doctors put him on immediately has not been FDA approved for use with children! I am extremely upset that I was never told this important fact and am concerned about any problems, side effects, long term effects, or complications NovoLog may cause. The doctor’s explanation was that hospitals and doctors prescribe unapproved medicines every day, and that’s just the way it is due to necessity, but I find this answer absolutely appalling and shocking! Can you help me or direct me to someone who can give me these answers? !! I don’ t know if I should change from NovoLog to Regular human insulin immediately or if there really is no imminent danger.

I absolutely understand your concern. I hope I can reassure you. In many ways, this is a matter of semantics.

“Non-FDA approved” is not the same as “FDA-disapproved.” Your physicians are correct: medications “approved” for adults are often used in children, even though there is not FDA-“approval” for use in children. Various life-saving heart medications, and even common diuretics (“water-pills”) are easy examples.”Non-FDA approved” means that the pharmaceutical company that manufactures the drug has not submitted clinical data on the use in children. They may or may not have the data, but did not submit any to the FDA for review. Therefore, the FDA can’t “approve” such a drug if they have no information to review. Indeed, the Clinton administration wanted to mandate that drugs be assessed in children so that these confounding issues can be clearer.

The drug information from the manufacturer of NovoLog cites their data in children as young as six years, explaining that the medicine worked similarly in children, adolescents, and adults. I happen to know that the company is currently involved in providing data to the FDA in order to be granted a younger child indication and therefore “FDA-approval.”

You may be interested to know that NovoLog is FDA-approved for use in insulin pumps. The other similar insulin, Humalog (produced by another company) has a pediatric indication, but for similar reasons noted above, does not yet have FDA-approval for use in pumps. However, Humalog was the primary insulin used in pumps before NovoLog reached the commercial market.

So much of the FDA-approval issue is more of an industry marketing issue more than a science issue. The key is whether the drug is not-indicated for use in the pediatric population (“disapproved”) vs not (yet) “approved.”

DS