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]It did not go through the standard FDA approval process. I know someone who works at FDA. You may want to see how a newly approved drug like this works on others before you jump into it. [/quote]

Why? The new drugs are a crapshoot on efficacy and have substantially worse side effects and safety profiles. Even if it ultimately doesn't work, it's worth a try just as much as the more dangerous drugs that are on-label.

Also, understand that the processes for updating labels are different and much less rigorous than the processes for approving a drug. This drug has already been approved for 70 years. Off-label prescriptions are both allowed and common, although given the litigious nature of modern society, some doctors are very reluctant to prescribe off-label in kids until it becomes common practice by others. Updating the label will hopefully facilitate more data, and if informal experiences and future clinical trials don't pan out, they can remove it from the label. Since the drug isn't dangerous in any meaningful way, there's no harm.[/quote]

So you just think the FDA approval process and research study methods are inapplicable to autism medications. OK! [/quote]

No, I'm saying the process for updating a label is always different than the process for initially approving a drug, whether it is for autism or any other condition.[/quote]

Can you provide support for that assertion? [/quote]

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