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

[Anonymous]

Anonymous wrote:

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Anonymous wrote:

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Anonymous wrote:

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.

Any person who thinks calling something a “vitamin” somehow makes the case for it being benign or safe sorely misunderstands the issues.

Youre right. I should have added thats water soluble. It isnt toxic nor build up in the human body.
Here's a list of side effects for the most common asd drugs plus leucovorin
Risperidone – can cause metabolic syndrome (weight gain, diabetes, high cholesterol), movement disorders (tardive dyskinesia, Parkinsonism), and hormonal effects (high prolactin → bone loss, reproductive issues).

Aripiprazole (Abilify) – generally less severe than risperidone, but can still cause movement disorders, metabolic changes, and rarely neuroleptic malignant syndrome.

Leucovorin – generally well tolerated, serious side effects are rare; it’s mainly supportive/filling in folate and not associated with long-term organ damage

Those two medications are for totally different autism symptoms. That’s an inapt comparison and just more evidence that you have no clue what you are talking about. I won’t even get into the notion that because it is “water soluable” that it is harmless.

Sorry you've been so wrong and are keeping yourself sick because of it. Thats sad.

Sorry you are terminally stupid. I guess your mom didn’t take her prenatal.

Remember back in the spring when I explained the FRAT and leucovorin and you accused me of working for the lab that does rhe FRAT test? I hope you mentioned that incident to your psychiatrist. Is it called paranoid delusions?

If you actually have a basis to provide medical advice or an expert assessment of the evidence, tell us your credentials.

Why would anyone believe what the pp claims for credentials?

There are, however, peer-reviewed papers to look at. I get the immediate instinct to discount anything that RFK and Trump say, but why not ignore what they say and look at the available data?

For the MILLIONTH TIME: I don’t think anyone here is disputing that it may be promising. The point is that the research is not done yet and Trump and RFK are pretending that it is, for political reasons.

You are sadly missing the point thst the research timeline of fifty years ago has been disrupted. It was disrupted during Covid and that was okay with you because your side was pushing for it. And it is disrupted now with Autism. But you are cawing and fear mongering about that because you have tds.

[Anonymous]

Anonymous wrote:So my autistic child started leucovorin for the + FRAT test. First slowly to 25 mg twice daily then we increased to final dose of 50 mg twice daily. It had been incredible to see the difference in behavior, all for the better. He was low energy before so all the temporary hyperactivity didn’t happen with us. He has decreased stimming, decreased anxiety, increased eye contact with strangers and better overall behavior. I am truly amazed and very grateful we tried this. Side effects are nothing compared to other behavior meds for ASD as another poster stated. For us this was life changing.

-a (democratic) doctor

To the poster above, how old was your son when you started tx with leucovorin?

[Anonymous]

How can you get a FRAT test for your child? Is it a test that a pediatrician can order?

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.

What do you think the answer would be if you asked parents if they wanted to try a drug now with a long safety history, that might not help, but that might lead to small-to-moderate improvements to verbal communication? Or if they'd rather wait for a couple years as their kid falls further and further behind?

They'd jump toward it.

I really don't think a lot of the posters here understand what kids and parents are already going through with medications. Even established drugs used for on-label indications have low efficacy and significant negative effects.

DP. How does this excuse Trump and RFK Jr engaging in this pump & dump scheme? When they are literally the two people in the entire country who could make the research happen so parents would have more to go on than “maybe this will help”.

And you are wholly ignorant if you think there is somehow no possibility of negative side effects. because of course the trials have *not been done* to find out.

Who said there was no possibility of negative side effects? Of course there is. But there's a 70-year history demonstrating safety, and recent studies involving kids with ASD demonstrating minimal side effects occurring at similar rates as placebo. Compare that to risperidone and Abilify. Or even methylphenidate and guanfacine.

Would I like to see more studies? Of course. Do I want to wait until they're done before looking at whether it plausibly might work for my son? Definitely not.

More studies are unlikely to answer the main question of efficacy: whether it will help my son. We've tried several on-label and commonly prescribed off-label medications over the years. Most didn't work. Many led to significantly worse behaviors. The available data on Leucovorin tells a pretty convincing story that it's better than most of what we've been through. It probably won't work, but it probably won't do as much harm as the other things we've tried.

You could probably call me a combination of selfish and impatient. But I've got a kid currently taking much more dangerous drugs with lackluster results at a critical time in his development. Waiting 2 or 3 years for a well-organized RCT would come too late. The odds of success are small, I know, but even small successes could be life-changing. Weighed against the outcome of doing nothing differently with my child, it seems like a very easy choice from a risk-benefit perspective.

I’m just going to quote the actual autism experts again:

“With this in mind,” the group added, “we do not support any recommendation from the HHS or FDA regarding increased use of folinic acid. Instead, we call for a well-designed, large scale clinical trial of leucovorin (folinic acid) with all of the rigor needed (biomarkers, proper endpoints) and, most importantly, a pre-registered analysis plan.””

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.

What do you think the answer would be if you asked parents if they wanted to try a drug now with a long safety history, that might not help, but that might lead to small-to-moderate improvements to verbal communication? Or if they'd rather wait for a couple years as their kid falls further and further behind?

They'd jump toward it.

I really don't think a lot of the posters here understand what kids and parents are already going through with medications. Even established drugs used for on-label indications have low efficacy and significant negative effects.

DP. How does this excuse Trump and RFK Jr engaging in this pump & dump scheme? When they are literally the two people in the entire country who could make the research happen so parents would have more to go on than “maybe this will help”.

And you are wholly ignorant if you think there is somehow no possibility of negative side effects. because of course the trials have *not been done* to find out.

Who said there was no possibility of negative side effects? Of course there is. But there's a 70-year history demonstrating safety, and recent studies involving kids with ASD demonstrating minimal side effects occurring at similar rates as placebo. Compare that to risperidone and Abilify. Or even methylphenidate and guanfacine.

Would I like to see more studies? Of course. Do I want to wait until they're done before looking at whether it plausibly might work for my son? Definitely not.

More studies are unlikely to answer the main question of efficacy: whether it will help my son. We've tried several on-label and commonly prescribed off-label medications over the years. Most didn't work. Many led to significantly worse behaviors. The available data on Leucovorin tells a pretty convincing story that it's better than most of what we've been through. It probably won't work, but it probably won't do as much harm as the other things we've tried.

You could probably call me a combination of selfish and impatient. But I've got a kid currently taking much more dangerous drugs with lackluster results at a critical time in his development. Waiting 2 or 3 years for a well-organized RCT would come too late. The odds of success are small, I know, but even small successes could be life-changing. Weighed against the outcome of doing nothing differently with my child, it seems like a very easy choice from a risk-benefit perspective.

I’m just going to quote the actual autism experts again:

“With this in mind,” the group added, “we do not support any recommendation from the HHS or FDA regarding increased use of folinic acid. Instead, we call for a well-designed, large scale clinical trial of leucovorin (folinic acid) with all of the rigor needed (biomarkers, proper endpoints) and, most importantly, a pre-registered analysis plan.””

There have been trials- one in the US, and a larger one in India. They both had pre-registered analysis plans.

Yes, they were small, but I don't understand the reluctance to accept them given the efficacy and dosing of ASD medications is always highly variable. If two double-blind RCTs found significant improvement to, say, cancer patients, using an established, safe drug, doctors would be jumping to try it before the label is updated. They're not going to tell patients to just hope that they're still alive in a few years after larger trials occur.

I could understand wanting more data before updating the label. I was initially under the impression that positive FRATs were not particularly common with ASD, making me think the applicable patient population is small. But, given the promising data and, especially, the safety record, I don't understand the opposition to off-label use.

The group you cited didn't just state caution and tell people to talk to their doctors. They're specifically advocating against off-label use. This isn't a situation where doctors always advise against off-label use. Most, if not all, doctors who treat ASD through medications end up commonly prescribing drugs off label.

That opposition to off-label use is what makes me think they probably need to update the label.

Some of this feels similar to the people that cautioned against the covid vaccines, suggesting that they were being rushed out before the election. People need to ignore Trump and RFK here. We all know they're idiots.

[Anonymous]

If your child has ASD, wouldn't you want to try everything? Try it for a month, if it does not work for you, move on to the next thing.

[Anonymous]

Anonymous wrote:If your child has ASD, wouldn't you want to try everything? Try it for a month, if it does not work for you, move on to the next thing.

Like we've done ten other times, often off-label...

The opposition here is really baffling given what is already commonly done.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.

What do you think the answer would be if you asked parents if they wanted to try a drug now with a long safety history, that might not help, but that might lead to small-to-moderate improvements to verbal communication? Or if they'd rather wait for a couple years as their kid falls further and further behind?

They'd jump toward it.

I really don't think a lot of the posters here understand what kids and parents are already going through with medications. Even established drugs used for on-label indications have low efficacy and significant negative effects.

DP. How does this excuse Trump and RFK Jr engaging in this pump & dump scheme? When they are literally the two people in the entire country who could make the research happen so parents would have more to go on than “maybe this will help”.

And you are wholly ignorant if you think there is somehow no possibility of negative side effects. because of course the trials have *not been done* to find out.

Who said there was no possibility of negative side effects? Of course there is. But there's a 70-year history demonstrating safety, and recent studies involving kids with ASD demonstrating minimal side effects occurring at similar rates as placebo. Compare that to risperidone and Abilify. Or even methylphenidate and guanfacine.

Would I like to see more studies? Of course. Do I want to wait until they're done before looking at whether it plausibly might work for my son? Definitely not.

More studies are unlikely to answer the main question of efficacy: whether it will help my son. We've tried several on-label and commonly prescribed off-label medications over the years. Most didn't work. Many led to significantly worse behaviors. The available data on Leucovorin tells a pretty convincing story that it's better than most of what we've been through. It probably won't work, but it probably won't do as much harm as the other things we've tried.

You could probably call me a combination of selfish and impatient. But I've got a kid currently taking much more dangerous drugs with lackluster results at a critical time in his development. Waiting 2 or 3 years for a well-organized RCT would come too late. The odds of success are small, I know, but even small successes could be life-changing. Weighed against the outcome of doing nothing differently with my child, it seems like a very easy choice from a risk-benefit perspective.

I’m just going to quote the actual autism experts again:

“With this in mind,” the group added, “we do not support any recommendation from the HHS or FDA regarding increased use of folinic acid. Instead, we call for a well-designed, large scale clinical trial of leucovorin (folinic acid) with all of the rigor needed (biomarkers, proper endpoints) and, most importantly, a pre-registered analysis plan.””

There have been trials- one in the US, and a larger one in India. They both had pre-registered analysis plans.

Yes, they were small, but I don't understand the reluctance to accept them given the efficacy and dosing of ASD medications is always highly variable. If two double-blind RCTs found significant improvement to, say, cancer patients, using an established, safe drug, doctors would be jumping to try it before the label is updated. They're not going to tell patients to just hope that they're still alive in a few years after larger trials occur.

I could understand wanting more data before updating the label. I was initially under the impression that positive FRATs were not particularly common with ASD, making me think the applicable patient population is small. But, given the promising data and, especially, the safety record, I don't understand the opposition to off-label use.

The group you cited didn't just state caution and tell people to talk to their doctors. They're specifically advocating against off-label use. This isn't a situation where doctors always advise against off-label use. Most, if not all, doctors who treat ASD through medications end up commonly prescribing drugs off label.

That opposition to off-label use is what makes me think they probably need to update the label.

Some of this feels similar to the people that cautioned against the covid vaccines, suggesting that they were being rushed out before the election. People need to ignore Trump and RFK here. We all know they're idiots.

So you know better than all the autism experts. Got it!

[Anonymous]

Anonymous wrote:

Anonymous wrote:If your child has ASD, wouldn't you want to try everything? Try it for a month, if it does not work for you, move on to the next thing.

Like we've done ten other times, often off-label...

The opposition here is really baffling given what is already commonly done.

*nobody is opposed to this medication being studied.* what we (and the autism experts) are objecting to is Trump and RFK Jr politicizing it and rushing it to market with insufficient research. and no, “trying everything” is not advisable. Because there are a lot of quacks out there ready to drain us of our money and in the worse case scenario push harmful remedies (bleach? Chelation?). Kids with autism deserve the best in scientific and medical research, not this.

[Anonymous]

Anonymous wrote:If your child has ASD, wouldn't you want to try everything? Try it for a month, if it does not work for you, move on to the next thing.

Yes! my son struggles to communicate and it is debilitating for him. It greatly affects his quality of life. I am hopeful this will help my son. I am fully aware that it may not. Trying it for a month seems like an easy choice.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:If your child has ASD, wouldn't you want to try everything? Try it for a month, if it does not work for you, move on to the next thing.

Like we've done ten other times, often off-label...

The opposition here is really baffling given what is already commonly done.

*nobody is opposed to this medication being studied.* what we (and the autism experts) are objecting to is Trump and RFK Jr politicizing it and rushing it to market with insufficient research. and no, “trying everything” is not advisable. Because there are a lot of quacks out there ready to drain us of our money and in the worse case scenario push harmful remedies (bleach? Chelation?). Kids with autism deserve the best in scientific and medical research, not this.

This. I've seen parents blow money on snake oil and things that can harm kids. Even if not actively harmful, spending hundreds or thousands of dollars chasing the next thing comes at an opportunity cost for many parents who then struggle to afford things that do help, like speech therapy.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:If your child has ASD, wouldn't you want to try everything? Try it for a month, if it does not work for you, move on to the next thing.

Like we've done ten other times, often off-label...

The opposition here is really baffling given what is already commonly done.

*nobody is opposed to this medication being studied.* what we (and the autism experts) are objecting to is Trump and RFK Jr politicizing it and rushing it to market with insufficient research. and no, “trying everything” is not advisable. Because there are a lot of quacks out there ready to drain us of our money and in the worse case scenario push harmful remedies (bleach? Chelation?). Kids with autism deserve the best in scientific and medical research, not this.

This. I've seen parents blow money on snake oil and things that can harm kids. Even if not actively harmful, spending hundreds or thousands of dollars chasing the next thing comes at an opportunity cost for many parents who then struggle to afford things that do help, like speech therapy.

+1. And it really bothers me to hear people claim “there are no risks, it is a water soluble vitamin!” Um yes there are - allergic reactions, increased seizures, behavior changes.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.

Any person who thinks calling something a “vitamin” somehow makes the case for it being benign or safe sorely misunderstands the issues.

Youre right. I should have added thats water soluble. It isnt toxic nor build up in the human body.
Here's a list of side effects for the most common asd drugs plus leucovorin
Risperidone – can cause metabolic syndrome (weight gain, diabetes, high cholesterol), movement disorders (tardive dyskinesia, Parkinsonism), and hormonal effects (high prolactin → bone loss, reproductive issues).

Aripiprazole (Abilify) – generally less severe than risperidone, but can still cause movement disorders, metabolic changes, and rarely neuroleptic malignant syndrome.

Leucovorin – generally well tolerated, serious side effects are rare; it’s mainly supportive/filling in folate and not associated with long-term organ damage

Those two medications are for totally different autism symptoms. That’s an inapt comparison and just more evidence that you have no clue what you are talking about. I won’t even get into the notion that because it is “water soluable” that it is harmless.

Sorry you've been so wrong and are keeping yourself sick because of it. Thats sad.

Sorry you are terminally stupid. I guess your mom didn’t take her prenatal.

Remember back in the spring when I explained the FRAT and leucovorin and you accused me of working for the lab that does rhe FRAT test? I hope you mentioned that incident to your psychiatrist. Is it called paranoid delusions?

If you actually have a basis to provide medical advice or an expert assessment of the evidence, tell us your credentials.

Why would anyone believe what the pp claims for credentials?

There are, however, peer-reviewed papers to look at. I get the immediate instinct to discount anything that RFK and Trump say, but why not ignore what they say and look at the available data?

For the MILLIONTH TIME: I don’t think anyone here is disputing that it may be promising. The point is that the research is not done yet and Trump and RFK are pretending that it is, for political reasons.

You are sadly missing the point thst the research timeline of fifty years ago has been disrupted. It was disrupted during Covid and that was okay with you because your side was pushing for it. And it is disrupted now with Autism. But you are cawing and fear mongering about that because you have tds.

Leucovorin was already being studied and doctors could already prescribe it off-label. What changed is that the FDA approved its use for children with autism, so now that’s no longer an off-label use. However, we don’t have sufficient data to prove this is a real game changer for most autistic kids. You wouldn’t know that from the press conference, where dangerous disinformation about vaccines was shared alongside the Leucovorin announcement. Trump and Kennedy have zero medical knowledge and each has a history of sharing harmful medical disinformation. Dr. Oz has a financial interest in selling supplements with folinic acid. Rate their enthusiasm for Leucovorin accordingly.

[Anonymous]

I will definitely want to try it for my autistic kid who struggles with communication issues. The drug has proven to be safe, and if it may work, why not? Of course, I'll do it under medical guidance. But I agree with previous posters that it is a shame that everything is so politicized now... This has potential, but people now only see it through the Trump's lens.

[Anonymous]

Anonymous wrote:I will definitely want to try it for my autistic kid who struggles with communication issues. The drug has proven to be safe, and if it may work, why not? Of course, I'll do it under medical guidance. But I agree with previous posters that it is a shame that everything is so politicized now... This has potential, but people now only see it through the Trump's lens.

The drug has not been “proven to be safe.” The question is the risks and benefits, which have not been established using the normal FDA process.

I don’t see this drug only through “Trump’s lens,” although I certainly hear echoes of ivermectin and hydroxychloroquine. I see the push and PR surrounding the drug very much the through the Trump lens.