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

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

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[quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous]I would love to hear other people experiences with Leucovorin[/quote]

Because we’re doing science by anecdote now I guess. [/quote]

Ever hear of case studies?[/quote]

Case studies are not the kind of evidence the FDA generally uses to determine the safety and efficacy of a medication. [/quote]

It's been used for 70 years. We already know it's safe.[/quote]

They put cocaine in cough syrup for 70 yesrs[/quote]

Do you not realize that Leucovorin continues to be used?[/quote]

… in cancer. Stop lying. [/quote]

You compared the safety record of Leucovorin to the safety record cocaine. I'm not the one being disingenuous. You can argue we don't know how effective it is for ASD, but we already know it's safe.

[/quote]

That wasn’t me but for the record cocaine actually does have medical uses right now (as a topical anesthesia). [/quote]

So do you think that makes the safety record of cocaine similar to the safety record of Leucovorin? Otherwise, what's your point?[/quote]

The point is that saying a drug is safe and effective for one indication says literally nothing at all about whether it is safe and effective for a wholly different indication. If you cannot grasp this entirely basic and fundamental point then you probably shouldn’t be in this discussion. [/quote]

Again, we don't know it is effective, but we do know it is safe. Safe doesn't necessarily mean there's absolutely no possibility of risk. We approve drugs and other substances while there is still small potential for risks, with after-market monitoring being used to catch exceptional events. Leucovorin has the substantial benefit over new drugs in that we already have a long safety history with the drug.

It's ridiculous to suggest it isn't safe. Particularly given the risks of other things that are available and generally accepted as safe- including prescription medications, supplements, and food ingredients.[/quote]

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. [/quote]

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.[/quote]

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. [/quote]

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.[/quote]

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