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Discussion

Fospropofol

Is anyone using Fospropofol/Lusedra? What do you think about it?

I haven't gotten to clinical yet, but I'm curious about how this drug is being received. Although I imagine that since it's new, it's expensive and not being widely used yet.

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    I've never heard of it. We used a lot of propofol when I was precepting in day surgery. Am I correct in assuming Fospropofol/Lusedra is a newer prototype of propofol?

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    Is anyone using Fospropofol/Lusedra? What do you think about it?

    I haven't gotten to clinical yet, but I'm curious about how this drug is being received. Although I imagine that since it's new, it's expensive and not being widely used yet.

    Fospropofol was specifically designed for sedation cases such as in the GI suite. The idea behind fospropofol (fos means that it is a prodrug) is that it is water soluble on injection and then after passing through the liver it actually becomes propofol. It allows for a nonburning longer acting version of propofol that in theory is supposed to be safer than propofol. Orginally the manufacture had hoped that they could bypass the FDA warning label on propofol that states it should only be used by anesthesia providers in nonintubated patients. That exclusion of the warning label did not happen and currently it carries the exact same warning label as propofol.

    Since, fospropofol is still recommended only to be used by anesthesia providers it hasn't gained much acceptance. Fospropofol takes longer to take effect and lasts longer than propofol which in general is the exact opposite of what we usually want as anesthesia providers.

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    Thanks for the info. You did a great job of explaining that.

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    I am not sure that fospropofol has hit the shelves yet. It only gained final approval in early November after being classified as a schedule IV controlled substance.

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    Yes, the drug itself was approved by the FDA last December. However it was then marked for review as a controlled substance. On October 6, 2009 the final order from the DEA was published, placing fospropofol under the controlled substance act as a schedule IV drug. The effective date of the order was November 5, 2009 so no fospropofol was sold before that date. In addition the manufacturer had to put into place all of the logistics of marketing a controlled substance.

    See; http://www.deadiversion.usdoj.gov/fed_regs/rules/2009/fr1006.htm

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    My understanding has been approved since December of last year. http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=1011

    The drug formulation was approved last December, however it was then flagged for review as a controlled substance. On October 6 of this year the final DEA order classifying it as a Schedule IV drug was published with an effective date of November 5. No fospropofol entered the market before that date. The maufacturer then needed to put all of the logistical components in place for marketing a schedule IV drug.

    See: http://www.deadiversion.usdoj.gov/fed_regs/rules/2009/fr1006.htm

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    Yes, it was approved Dec 08 and made available for use Nov 09.

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    I think that earlier concerns about a Propofol shortage may have given Fospropofol a bit of a shove out the door. AANA said it was made available for use on Nov 16th, 2009.

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    The idea was to avoid the black box warning associated with Propofol. So why would CRNAs use it? More expensive than Propofol, and just does the same thing? (as I understand it) Although the message above says it is not as good. I have never seen it. And as for a propofol shortage, never saw that either.

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    The idea was to avoid the black box warning associated with Propofol. So why would CRNAs use it? More expensive than Propofol, and just does the same thing? (as I understand it) Although the message above says it is not as good. I have never seen it. And as for a propofol shortage, never saw that either.

    Fospropofol was developed in the hope to avoid the black box warning so regular RNs could use it for sedation cases. Fospropofol gives choice to have less titrating and longer acting effects since it is a pro-drug. As far as propofol shortage goes my facility and the local area has propofol shortage so we are using gas inductions or etomidate inductions. I still think it is awful strange that about the time fospropofol gets approved that propofol and thiopental have a sudden nationwide shortage.

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