Leucovorin now approved by FDA--will providers prescribe to ASD kids?
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Anonymous
Can you provide support for that assertion? |
Anonymous
No we do NOT KNOW if it is safe in the population it is now being touted for. It has side effects that absolutely could be more unsafe for kids with autism vs adults with cancer. Specifically, seizures and aggression are known side effects and these are bigger concerns for autism. AND there is also research connecting too much prenatal folate to autism. We.do.not.know. |
Anonymous
Other administrations likely wouldn't have the narcissistic personalities insisting on making it a political event, but there certainly would have been public and political pressure to facilitate use. You see this in more extreme cases- people pressuring the FDA to open up drugs that *don't* have established safety records for compassionate use. |
Anonymous
They did a lot more here than compassionate use (which is generally on an individual level and a last ditch effort when the person is dying). Totally different from rushing a med for otherwise physically healthy *children*. |
Anonymous
On that basis, almost nothing is "safe" for use in kids with autism because these kids often aren't part of clinical trial populations. Since you're saying a safety record for the general population shouldn't be used to infer safety in a subpopulation. Again, you're being disingenuous. This is done all the time. Heck, look how often drugs get prescribed off-label because of how hard it is to run trials (particularly in kids). Frankly, off-label use here would seem to be the right move, too. But clearly something has happened over the last 10 years, and particularly with this drug, to make some doctors lose their ability to weigh risks and potential benefits rationally and in the best interest of their patients. Why are they treating it so differently than something like guanfacine, another drug with a long safety history that is frequently prescribed for young kids with autism presenting with aggressive or self-injurious behaviors, despite those being off-label. |
Anonymous
This is a drug being specific touted FOR kids with autism. So yes, it is relevant to ask how it specifically affects them. And of course the whole point is that this went far beyond off-label use, departing from how additional uses are added and making overblown claims not supported by the evidence. More importantly while it may be an understandable stance for an individual parent with their doctor to use a med off-label under the background of slow or nonexistent goldstar research - that is far different from the people *literally in charge of the research* upending it. Trump and RFK jr are pretending like they aren’t the ones with the power to actually do the research our kids deserve. because they don’t actually care about our kids. They care about politics. |
Anonymous
These aren't healthy children. They are children with a profound disabilities that have a short window of time during childhood to reach important developmental milestones. Like "last ditch efforts" for dying cancer patients, this is worth substantial risk. And that's reflected by the side effects of the drugs approved and commonly prescribed for ASD, despite not being particularly effective. In comparison, Leucovorin has a remarkable safety profile. Adjusting expectations/demands for efficacy accordingly, there's no rational cost-benefit analysis that wouldn't lead you to conclude it is worth a shot in kids profoundly impacted by autism. |
Anonymous
The reality of modern medicine is that doctors now want top-cover for prescribing medications- particularly in kids. Guanfacine was able to become common before those pressures shifted. The only way we can really provide that top-cover is adding it to the label. If a doctor isn't satisfied there's a good risk-benefit tradeoff based on the available data, then they obviously don't need to prescribe it. It's not like they're trying to make this available OTC without a prescription. |
Anonymous
I thought we were past the point where we disregarded any harms of autism therapy because autism is uniquely bad. Or are we back to bleach, chelation, shocks and Lovaas abuse? And the label is for autism not “severe autism.” Also you need to stop comparing leucovorin to Abilify and Risperdal. Those meds are approved for specific severe autism symptoms (aggression) where the benefits may outweigh the risks. They are not for the core autism symptoms that Leucovorin is being touted for. They have nothing to do with each other. Our kids deserve the best in research not incomplete research pushed by quacks. |
Anonymous
Forgive me if I expect more from the people and institutions literally in charge of making the determinations of what can be prescribed safely. That’s the insane part. You’re saying that because our research and prescribing systems are not ideal that the people in charge of our research and prescribing systems have no other choice but to shrug their shoulders and say “the system sucks, take whatever”? |
Anonymous
"Severe autism" isn't a medical term with clear criteria. Even the severity levels are very limited in their ability to describe the symptoms and needs of a patient. The idea that the label is apparently being updated for "autism" does not mean it is appropriate for any patient with autism. That's why doctors need to evaluate patients and determine medications. Also, the labels for risperidone and Abilify aren't as narrow as you suggest. The label is for "irritability." Of course, you're right that that doctors will generally attempt to try other (often off-label) medications before prescribing risperidone or Abilify, or will reserve it for cases presenting with the most severe or dangerous symptoms, but the label gives doctors, patients, and parents the ability to make the appropriate cost-benefit determinations. |
Anonymous
The status quo basically is: "there aren't great medications, but you can try these things." And let's be clear, if the FDA updates the label, that isn't telling people to "try whatever." It is telling people to talk to their doctors about Leucovorin for kids with autism. It doesn't make it directly available to parents or patients. It doesn't tell doctors they need to offer to everyone with autism, or to anyone at all. It just makes it available as an option at a lower professional and legal risk to the prescribing physician. And a clearer path for insurance coverage. |
Anonymous
No matter how much you insist that nothing out of the ordinary happened here, we all know it did. And all for the purpose of aggrandizement of Trump, not for the purpose of helping our kids. Where’s the funding for additional studies on leucovorin? maybe that was included in the announcement and I missed it. |
Anonymous
| We live in NW but go to an autism specialist who actually has authored many studies on Leucovorin and autism. Look up drs Frye and Rossignol. They have data going back years. My dd has been on it for 5 years. They don’t put all of their patients on it. You need to do a FRAT test first to see if you have antibodies, etc. I hate that now everyone is jumping on board, regardless of if it will be effective. It’s not going to be effective for a large percentage of autism patients who don’t have a positive on the FRAT test. |
Anonymous
And this is why guidance is needed. Folks you really will have to do your own research in medical journals from now on out. |