July 28, 2002
Question from Buffalo, New York, USA:
My 26 month son has had type 1 diabetes for over a year, and I definitely want to try the Lantus. However, I thought Lantus wasn't recommended for children yet. Any there any disadvantages to Lantus? I know you can't mix it with Regular insulin and more daily shots may be needed.
Lantus (insulin glargine) is not recommended by the manufacturer, and does not have FDA approval, for use in children under age six. This is not the same that Lantus is disapproved or disallowed in those cases. It mostly means that it is unproven and untested in that population.
The major issues with Lantus are those that you have mentioned. It cannot be mixed with other insulins and must be a stand alone shot. It does not yet come as a cartridge so it must be given with a syringe and needle. It does tend to sting for the initial shots in some patients. In order to avoid the possibility of accidentally mixing the Lantus with the short-acting insulin, I recommend that the short-acting insulin be given with an insulin pen.
Because it cannot be mixed and the other considerations above, some clinicians will use Ultralente as the long-acting insulin in these patients going on basal/bolus therapy. Ultralente used to be thought to be a non-peaking insulin, but some evidence shows that it does peak — perhaps even erratically. Nevertheless, Ultralente is a long-acting insulin that sometimes can be given once every 24 hours, but my experience is that in younger children it tends to last closer to 12 hours so it must be given twice daily. However, it can be mixed with other insulins in the same syringe.
Additional comments from Dr. Tessa Lebinger:
Besides the fact that you can’t mix Lantus with any other insulin in the same syringe, the other drawback is that you can’t dilute it as you can other insulins to facilitate giving small amounts or making small changes at a time. Unfortunately, in the US, new drugs are still cleared by the FDA before they are tested in children. The FDA requires much more testing in children to establish safety than in adults, so it takes longer and costs more money. I am not aware of any problems in children, it just hasn’t officially been tested and cleared by the FDA. You and your child’s physician can decide whether or not to use it.
Additional comments from Dr. Donough O’Brien:
It is true that Lantus is not yet formally approved for children, this however is largely a financial decision because of the exorbitant cost of getting approval from the FDA.. In fact, Lantus has been widely and successfully used in children and teenagers.
The disadvantages are minor in that it occasionally seems to fade a little at the end of the 24 hour period. and of course it does involve an additional injection, but his can often be offset by giving Humalog or NovoLog and NPH at breakfast time, no insulin in the middle of the day and Humalog or NovoLog again at supper and Lantus at bedtime. A few people don’t like Lantus, although most children seem to feel better on it and certainly at camp there was significantly less hypoglycemia in the children on this insulin.
Additional comments from Shirley Goodman, diabetes nurse specialist:
Lantus has not received FDA approval as a safe or effective drug in children under age 6. While it is not uncommon for new drugs on the market to lack studies in certain age groups, and many commonly used medications in the US have not received FDA approval in the very young, it is a consideration in recommending a medication. There are some physicians who have chosen to prescribe Lantus to young children and are comfortable continuing to prescribe it. There are other physicians who are not as comfortable prescribing it off-label, who prefer to wait until the safety data has been reviewed in the under 6 age group.
I would encourage any parent to speak with their child’s physician about any change they are interested in making, read the package insert for any drug prescribed or under consideration for their child, and ask questions of their healthcare team.