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Off Label Medication Use

“I have a question regarding my baby’s constipation. He is 11 1/2 months old and has some seriously hard and uncomfortable B.M’s. Our doctor has given us a prescription for Miralax. We got the generic brand Glycolax. On the package it says that pediatric use has not be proven safe and that children should not use it. It also says not to use for more than 2 weeks. I asked my doctor about this and he says it is not FDA approved because they don’t have children’s doses. Since he prescribed only half of the amount that an adult should take, he said it was perfectly safe. We have used it for 2 days and I can’t help but be uncomfortable using it. It works, but my question is it safe for my 11 1/2 month old. I read your advice about using Flax seed oil. Do you think it would be strong enough for my baby’s constipation and is it safe to use for an extended period? I would like to use a more natural remedy, but I don’t feel like “testing” it out on my baby and having go through so much pain if it doesn’t work. Prunes and pears haven’t helped. I think I need some advice, and to know if the drug is safe to use on him.”

Many pediatricians use medications that are not approved for kids – this is called “off-label use”. For example, a certain cream that is only approved for 6 year-old, but I feel comfortable using it in a 4 year old. This is quite common. Most of the time, there is no problem, and after further testing and experience, the medication then becomes approved for younger children. Other times, questions about safety arise and pediatricians need to stop using the med. I seldom use Miralax as part of treating constipation, I would not be comfortable using it off label. Doesn’t mean it’s not safe, just means that I haven’t used it enough to be comfortable. If your doctor is comfortable, and you trust him/her – then go with that.

I do often use Flax seed oil as part of my constipation “arsenal” and highly recommend it. This is something that is good for you anyway. Click here to read more about constipation.

Dr. Jim

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