Topical Lamisil in Peds

[aelephant]

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Doctor asked me this morning if she can use topical Lamisil for a 9 year old kid. I wasn't sure, so I checked UpToDate, which says >=12 years old for the topical products.

I wonder, "Why shouldn't kids less than 12 use topical Lamisil? What happens if they use it?"

I see ORAL Lamisil is used in kids as young as 4. I see topical absorption is <5%.

Based on this, it seems obvious to me that this >=12 years old thing for the topical product is baloney. Anyone have any input? Perhaps someone who works in Peds? Is topical Lamisil used all the time in kids and I just didn't know it or do people heed these ridiculous warnings?

Where does this kind of irrational information come from in the 1st place and why are the drug info databases perpetuating it?

 

[Ackj]

Doctor asked me this morning if she can use topical Lamisil for a 9 year old kid. I wasn't sure, so I checked UpToDate, which says >=12 years old for the topical products.

I wonder, "Why shouldn't kids less than 12 use topical Lamisil? What happens if they use it?"

I see ORAL Lamisil is used in kids as young as 4. I see topical absorption is <5%.

Based on this, it seems obvious to me that this >=12 years old thing for the topical product is baloney. Anyone have any input? Perhaps someone who works in Peds? Is topical Lamisil used all the time in kids and I just didn't know it or do people heed these ridiculous warnings?

Where does this kind of irrational information come from in the 1st place and why are the drug info databases perpetuating it?

Can't speak on this particular drug, but unless there is solid data that it's safe for kids, they're not going to suggest that it is. You might find case reports/anecdotes that support it, and that would be fine, it's just that it can't be marketed or indicated for those groups without the data. Kind of like pregnancy categories, a drug can end up as B or C because there is a lack of data, not because it's actually harmful.

 

[aelephant]

Can't speak on this particular drug, but unless there is solid data that it's safe for kids, they're not going to suggest that it is. You might find case reports/anecdotes that support it, and that would be fine, it's just that it can't be marketed or indicated for those groups without the data. Kind of like pregnancy categories, a drug can end up as B or C because there is a lack of data, not because it's actually harmful.

Right. It seems the age ranges in most cases are based on what has been proven safe, not on what has been proven harmful. Lack of evidence of safety is not evidence of harm.

One exception I can think of is tetracycline antibiotics and kids <9. In this case the age recommendation is based on what has been proven harmful.

 

[moolman]

It's because the manufacturer didn't go through the process of getting it approved for those under 12 yo. It costs money to do the studies and they don't think it's worth it.

Now is it safe, probably, people use it on kids all the time for athlete's foot, ring work etc.

Should you recommend it when a patient comes to the counter or a MD asks for a recommendation? I wouldn't, for liability reasons. You might get that one kid that has some rare fatal reaction to Lamisil and the first thing they will point out is that it's not for kids under 12. That's the pharmacists life..