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North American Coral Snake Antivenin
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by Crazywolf on November 4, 2008
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Quote:
Originally Posted by FDA Center for Biologics Evaluation and Research
North American Coral Snake Antivenin (Micruris fulvius) (Equine) Lot 4030026 - Extended Dating Period to October 31, 2009
This is to provide you with important information regarding Antivenin (Micruris fulvius) (Equine), commonly referred to as North American Coral Snake Antivenin. Antivenin (Micruris fulvius) (Equine) is indicated for treatment of envenomation by Micruris fulvius fulvius (Eastern Coral Snake) and Micruris fulvius tenere (Texas Coral Snake). This product was manufactured by Wyeth Pharmaceuticals.
FDA has extended the expiration date on this lot of Antivenin (Micruris fulvius) (Equine). The extension is based upon FDA evaluation of stability data, which determined that this lot of product will maintain stability and potency for an additional year.
Wyeth Pharmaceuticals no longer manufactures Antivenin (Micruris fulvius) (Equine). There is no alternative product licensed in the U.S. for coral snake envenomations. Lot 4030026 is labeled with an expiration date of October 31, 2008. Because this lot has a new expiration date, you may continue to maintain the product in your inventory and keep it available for use until October 31, 2009. The manufacturer is updating the current labeling through a Dear Health Care Provider Letter.
Lot 4030026 continues to be available. Wyeth is closely managing their inventory, and will supply product only to direct customers.
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RE: North American Coral Snake Antivenin
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by Crazywolf on November 4, 2008
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this is a direct quote from the girl who posted this article in the herp society that i found this............
"
To sum up the FDA alert below, apparently the only manufacturer of antivenom for the North American Coral Snake has decided to stop making it. The FDA is extending the final lot#'s expiration date for a year...but then what happens??
So, all you venomous fans out there...don't touch the coral snake!"
yeah,....then what happens?
any thoughts?
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RE: North American Coral Snake Antivenin
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by Crazywolf on November 4, 2008
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you know what?
im reading this over and over, it dosnt exactly say thier going to stop making it, it just says the expiration date is being extended for a year.
am i confused? she thinks they are ending production, but i just see a letter of extension.
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RE: North American Coral Snake Antivenin
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by agkistrodude on November 4, 2008
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Wyeth has discontinued the production of coral snake antivenin.No $$ in it. The new antivenin I believe is made in Mexico,(Bioclon) is as good or better, cheaper, but not yet FDA approved.I think it is available if needed.Maybe some others have more info on this.Type "Wyeth" in the search engine on this site and you'll find past threads on this issue.In the meantime, be careful will those corals! Take care, Marty
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RE: North American Coral Snake Antivenin
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by Cro on November 4, 2008
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Marty is right, the Bioclon Coralmyn is not FDA approved for general use in this Country yet, but is in clinical trials at some locations, which allow it to be used because there is nothing else available.
That would mean that it is available at some hospitals and at Miami Dade Venom 1, and some zoos. If someone were bitten by a Coral Snake, it could be many hours before antivenom was available.
If you mess with Coral Snakes, it would be best if you keep your fingers out of their mouths !
Best Regards John Z
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RE: North American Coral Snake Antivenin
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by Crazywolf on November 4, 2008
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so production is indeed coming to a halt?
but there is another antivenin in production? hopefully by 2009 it will be fda approved, right?
or is this time length possible?
i like that...."it is best to keep your fingers out of their mouth"
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RE: North American Coral Snake Antivenin
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by LarryDFishel on November 4, 2008
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For reference, most (as far as I know all) antivenoms for exotic species are not FDA approved but can be legally aquired and used if necessary. It's mostly just a little extra paperwork.
The difference is that since coral snakes are native, the lack of antivenom would affect more than just snake keepers. So, there is a push to get the Bioclon product approved, at least partially (I suspect) to overcome the reluctance of many hospitals to use something unapproved for fear of lawsuits.
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RE: North American Coral Snake Antivenin
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by Cro on November 4, 2008
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Larry brings up an interesting point, and it is something that Chris touched on during his talk at the SHHS Banquet.
Basically, hospitals are allowed to use non FDA approved antivenoms, if, there is not a US approved one available for the snake involved, or, if the US type antivenom is not working.
For instance, Cro Fab is FDA approved for "mild" and "average" snake bites, but not for "severe" snake bites. This would allow the use of a non approved antivenom if the bite was deemed "severe."
Also, CroFab is approved for up to 18 vials. If the bite is not responding to that many vials of CroFab, then a different antivenom can be used, like the Mexican made Antivipmyn.
Best Regards John Z
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RE: North American Coral Snake Antivenin
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by COBRAMAN on November 4, 2008
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To answer the "What next?" question... If there is no antivenom available to treat a Coral Snake bite, the patient will simply have to be put on a ventilator until the venom runs its course and is filtered out by the kidneys.
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RE: North American Coral Snake Antivenin
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by Cro on November 4, 2008
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Ray, good to see you posting here.
Your profile mentions that you are planning on writing a book on snake bite treatment for medical folks.
I look forward to seeing that published, as it is something that is much needed, not only by medical people, but also by venomous reptile keepers who want to know as much about their animals as they can.
Best Regards John Z
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