Leucovorin now approved by FDA--will providers prescribe to ASD kids?

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:They’ve never done large scale studies to determine safety, dosing, side effects, etc.
sounds unsafe to me.

You mean like they didn’t for the COVID vaccine? I agree, unsafe.

Make sense, congenital, chronic neurodevelopmental disorders are the same as novel, fatal, viral diseases spread by respiratory droplets so we should approach the development of therapeutics for them in the same way.

DP. what? coronaviruses are not novel.

[Anonymous]

Anonymous wrote:

Anonymous wrote:I mean, there’s not much in the way of harm here. Folate is water soluble so if it’s too much you just pee it out. Worth a try anyway.

The limited study they did suggests there are potential behavioral side effects to this drug. So, yes, it could negatively impact kids.

Sigh. Have you ever looked at the side effects for the drugs that are actually approved and widely used for autism. Risperdal and Abilify? What is behavioral side effects compared to type 2 diabetes and gambling/porn addiction?

[Anonymous]

Anonymous wrote:

Anonymous wrote:I mean, there’s not much in the way of harm here. Folate is water soluble so if it’s too much you just pee it out. Worth a try anyway.

The limited study they did suggests there are potential behavioral side effects to this drug. So, yes, it could negatively impact kids.

That's pretty much the same as any of the drugs that get prescribed for ASD-related behaviors/issues. The idea that you might need to stop the medication if behaviors get worse isn't much a problem. Anyone with a kid taking meds has probably been through a ton of instances of that.

[Anonymous]

Things White House autism announcement did not do:

-Discuss strategies to increase supports and services for autistic people/families
-Highlight why autistic people and families deserve respect, not pity or fear
-Endorse one speck of autism research that is not dangerous pseudoscience

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:I mean, there’s not much in the way of harm here. Folate is water soluble so if it’s too much you just pee it out. Worth a try anyway.

The limited study they did suggests there are potential behavioral side effects to this drug. So, yes, it could negatively impact kids.

That's pretty much the same as any of the drugs that get prescribed for ASD-related behaviors/issues. The idea that you might need to stop the medication if behaviors get worse isn't much a problem. Anyone with a kid taking meds has probably been through a ton of instances of that.

But those drugs weren’t approved based on politics and a much lower standard of review. That’s the point. of course every thing has risks and benefits and SN parents are the must vulnerable to quacks and shams of all types. That’s why our kids deserve therepeutics to be assessed by top flight research. Which did NOT happen here.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:I mean, there’s not much in the way of harm here. Folate is water soluble so if it’s too much you just pee it out. Worth a try anyway.

The limited study they did suggests there are potential behavioral side effects to this drug. So, yes, it could negatively impact kids.

So stop if it does. The sky is not falling here.

Treating kids as unwitting lab rats, on something that might cause aggression isn't a trivial matter.

That's already the baseline. The patient profile here is already taking a combination of medications that aren't particularly effective, have significant side effects, and that interact with each other in unpredictable ways.

What I find most interesting about this is that it is tied to biochemistry in a way that we can test for (to a certain degree). Pretty much everything else is trial-and-error, sometimes with drugs with not-great safety profiles. Being able to screen for this through a family history and blood test is great, even if it isn't very common. The drug is safe enough it probably just makes sense to try it if the FRAT comes back positive. And even if efficacy is low, that's pretty much the same as the other drugs.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:I mean, there’s not much in the way of harm here. Folate is water soluble so if it’s too much you just pee it out. Worth a try anyway.

The limited study they did suggests there are potential behavioral side effects to this drug. So, yes, it could negatively impact kids.

That's pretty much the same as any of the drugs that get prescribed for ASD-related behaviors/issues. The idea that you might need to stop the medication if behaviors get worse isn't much a problem. Anyone with a kid taking meds has probably been through a ton of instances of that.

But those drugs weren’t approved based on politics and a much lower standard of review. That’s the point. of course every thing has risks and benefits and SN parents are the must vulnerable to quacks and shams of all types. That’s why our kids deserve therepeutics to be assessed by top flight research. Which did NOT happen here.

One of the many, many problems with Trump and RFK running things is that we don't really know. But just like it wasn't right to automatically dismiss the covid vaccines as being rushed for political reasons, this shouldn't be entirely dismissed.

As previously noted in this thread, this isn't new. People have been looking at this for 20 years. And there's a moderately inexpensive blood test that can indicate whether there's a plausible reason to try it in a patient.

I certainly don't think anyone should run out and start their kid on Leucovorin. But, if there are risk factors, like other autoimmune disorders, it might be worth ordering a FRAT.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:I mean, there’s not much in the way of harm here. Folate is water soluble so if it’s too much you just pee it out. Worth a try anyway.

The limited study they did suggests there are potential behavioral side effects to this drug. So, yes, it could negatively impact kids.

So stop if it does. The sky is not falling here.

Treating kids as unwitting lab rats, on something that might cause aggression isn't a trivial matter.

That's already the baseline. The patient profile here is already taking a combination of medications that aren't particularly effective, have significant side effects, and that interact with each other in unpredictable ways.

What I find most interesting about this is that it is tied to biochemistry in a way that we can test for (to a certain degree). Pretty much everything else is trial-and-error, sometimes with drugs with not-great safety profiles. Being able to screen for this through a family history and blood test is great, even if it isn't very common. The drug is safe enough it probably just makes sense to try it if the FRAT comes back positive. And even if efficacy is low, that's pretty much the same as the other drugs.

Absolutely not. Layering on an under-tested medication is not some kind of advance. As well the “biochemistry” halo is a just-so story. By all means study this medication further but you can’t just make sh*t up. Our kids deserve better research than that.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:I mean, there’s not much in the way of harm here. Folate is water soluble so if it’s too much you just pee it out. Worth a try anyway.

The limited study they did suggests there are potential behavioral side effects to this drug. So, yes, it could negatively impact kids.

That's pretty much the same as any of the drugs that get prescribed for ASD-related behaviors/issues. The idea that you might need to stop the medication if behaviors get worse isn't much a problem. Anyone with a kid taking meds has probably been through a ton of instances of that.

But those drugs weren’t approved based on politics and a much lower standard of review. That’s the point. of course every thing has risks and benefits and SN parents are the must vulnerable to quacks and shams of all types. That’s why our kids deserve therepeutics to be assessed by top flight research. Which did NOT happen here.

One of the many, many problems with Trump and RFK running things is that we don't really know. But just like it wasn't right to automatically dismiss the covid vaccines as being rushed for political reasons, this shouldn't be entirely dismissed.

As previously noted in this thread, this isn't new. People have been looking at this for 20 years. And there's a moderately inexpensive blood test that can indicate whether there's a plausible reason to try it in a patient.

I certainly don't think anyone should run out and start their kid on Leucovorin. But, if there are risk factors, like other autoimmune disorders, it might be worth ordering a FRAT.

Who dismissed leucovorin? I certainly did not. I said it has not been adequately tested and is now being used as a political prop.

[Anonymous]

Anonymous wrote:I’m going to wait until it’s approved in Canada or Europe. I’d be happy for my child to take it is it’s safe and IF my child is shown to have the sub-type of autism that is improved by the medication.

Same. We have an excellent psychiatrist to advise us.

[Anonymous]

It’s the least of our problems but I cringe at the thought of how many Fox News grandparents and other family are going to ask parents whether they used Tylenol and whether or not they have tried Leucovorin.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:It’s wild to ignore treatment developments for your child because you don’t like that someone you hate talked about it. Didn’t you take prenatal vitamins when pregnant? Folate has long been known to be important for brain development.

It's understandable given the source. But just ignore RFK and Trump and look at the existing information and studies.

Which are not at all enough to say anything. The main trial was 40 kids.

That wouldn't be enough to approve a new drug, but it wouldn't be usual for supplemental labeling changes for an already-approved drug, which is the situation here.

If tests find Folate Receptor Alpha Autoantibodies in a patient, this certainly looks like a worthwhile treatment to try. Leucovorin has a long safety record.

I think some of the posters here both think Leucovorin is a new drug (is isn't- it's been approved since the 1950s) and that its use on kids for autism is a new idea (it's not- it's been studied for almost 20 years).

Forgive me for having a higher standard than “certainly looks useful to try” - particularly when its side effects exacerbate some of the most serious symptoms of autism (aggressive behavior)

DP here. I am not a Trump or RFK supporter and I love vaccines
But do you have an autistic child? Do you treat children with autism? Do you have any relevant experience that would drive you to harp on the side effects of leucovorin or are you just here to bash MAGA? Because this is a forum for parents of kids with special needs and disabilities.

While there are very real and legitimate concerns about the FDA approving the use of leucovorin for autism, there is some research to support its use in certain kids with autism, a test to determine whether it might be useful, and very few doctors that know of this test or are willing to sign off on it. We don't need you to insist it is a horrible idea based on the fact that Trump is horrible. Don't fall into the trap of just opposing everything he supports because he supports it.

Yes Karen I do have a child with autism, and I have always been very rigorous with the treatments, tests, therapies and accommodations he gets. It doesn’t take a genius to see that Trump is pushing this because it is the only way to salvage the smoldering disaster that Doge and RFK Jr wreaked on the HHS agencies. It’s a complete farce. That doesn’t mean that the drug should not be studied or doesn’t have merit … just like bleach could be used to disinfect surfaces you shouldn’t drink it as a prophylactic because Trump says so.

To the point - “SOME” research is a drastic departure from the level of research I demand from any medication I give my kid. I would very much like this to continue to be studied in the normal way, like any other pediatric medication. Too bad Trump threw our entire medical research apparatus into disarray huh?

I'm not sure what you would find rigorous or persuasive. Drugs like guanfacine were and are frequently prescribed off-label. It isn't highly effective, but the negative side effects also aren't serious, so it often ends up being a first-line treatment (especially in off-label age groups). Stimulants often increase rigidity and can lead to increased SIBs. Antipsychotics like risperidone and abilify have moderate efficacy, but come with substantial risks.

The reality is, given the lack of safe and highly effective medications for ASD, doctors already use an approach of "throw stuff against the wall and see what sticks." And as bad as that is, it is still better than the alternative.

[Anonymous]

Anonymous wrote:

Anonymous wrote:Can you really buy this over the counter? Can someone post a link if so? I know that folinic acid is not the same as methlyfolate.

As a mom of an ASD boy with limited verbal communication, I am interested in trying this. I am obviously concerned about side effects but I think people are not taking into consideration how debilitating it is to struggle with communication. I watch my child struggle all day every day. So from my perspective this drug or vitamin is worth a try. I think everyone understands it is not a cure... but it seems it has helped some kids.

Its a prescription drug. The question is, is a study with 40 kids a good enough reason to give your kid a prescription drug (already approved, this is an off-label use), that may or may not work, or would you prefer to wait a couple of years for actual studies that would figure out a) how do we figure out which kids it works for, b) what are the correct doses and dispensing instructions and c) what other factors (like speech therapy) should be provided in conjunction for the drug treatment to be most effective?

Wait, that's a false choice because DOGE and RFK Jr. fired everyone at the NIH and cancelled all the university research funding for autism.

I found this study from 2016. As others have said there have been multiple studies over the years. https://www.nature.com/articles/mp2016168

[Anonymous]

Anonymous wrote:I would hope that most competent providers would wait for actual evidence, instead of relying on the say-so of two non-doctors who also believe that horse dewormer cures covid.

There are numerous small scale studies from all over the world. There was an announcement yesterday of 50M in funding for lather studies.
Any doctor who tells you that they can not prescribe a vitamin for your autistic child is not the doctor for you.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:I mean, there’s not much in the way of harm here. Folate is water soluble so if it’s too much you just pee it out. Worth a try anyway.

The limited study they did suggests there are potential behavioral side effects to this drug. So, yes, it could negatively impact kids.

So stop if it does. The sky is not falling here.

Treating kids as unwitting lab rats, on something that might cause aggression isn't a trivial matter.

That's already the baseline. The patient profile here is already taking a combination of medications that aren't particularly effective, have significant side effects, and that interact with each other in unpredictable ways.

What I find most interesting about this is that it is tied to biochemistry in a way that we can test for (to a certain degree). Pretty much everything else is trial-and-error, sometimes with drugs with not-great safety profiles. Being able to screen for this through a family history and blood test is great, even if it isn't very common. The drug is safe enough it probably just makes sense to try it if the FRAT comes back positive. And even if efficacy is low, that's pretty much the same as the other drugs.

Absolutely not. Layering on an under-tested medication is not some kind of advance. As well the “biochemistry” halo is a just-so story. By all means study this medication further but you can’t just make sh*t up. Our kids deserve better research than that.

You seem to be holding this to a much different standard than other medications for ASD.

Do I think a press conference with Trump and RFK was the right way to raise this? Of course not. And maybe formally re-labelling is premature- I don't really know. But when dealing with an established drug with a solid safety record, pediatric patients, and a rare condition, a couple/few studies of ~40 kids very well might be enough.

I tend to think it would make more sense to expand access to the FRAT and informally accept off-label use as we get more data on it.