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August 11, 2006

Pills for Diabetes

Question from Connecticut, USA:

I am a pharmacist. I was given a prescription for Actos for a seven year old obese child. The doctor said the child has taken it before, but I cannot find any information about its safe use by children. Can you provide me with information?


Pioglitazone (Actos) is not FDA-approved for use in pediatric patients. That said, a licensed physician can prescribe whatever legal substance, off label.

There is a small body of literature on the use of pioglitazone and other thiazolidinediones in pediatric patients with obesity and fatty-liver disease; pharmacokinetic studies; and others. As you know, just because a drug is “not FDA-approved” does not mean that is “disapproved” by the FDA.

Pharmaceutical companies have little interest in doing the clinical trials needed in children for a drug that likely will not have much of a pediatric market. Unfortunately, we are seeing more obesity and type 2 diabetes in children now.

So, with bias, I say: fill the prescription.