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Coral snake antivenin supply in danger of running
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by tigers9 on May 17, 2010
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http://www2.tbo.com/content/2010/may/17/coral-snake-antivenin-supply-danger-running-out/news-breaking/
Coral snake antivenin supply in danger of running out
Florida Fish and Wildlife Conservation Commission
The problem is it's hard to make money off a drug that's used to treat only about 100 coral snake bites a year.
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By KEITH MORELLI | The Tampa Tribune
Published: May 17, 2010
Related Links
• Database: Snake owners
• Florida animal attacks
TAMPA - Here's something you don't want to experience while cleaning out some dead brush from under your deck: A nip on the finger from a slender yellow, red and black snake.
If the color schemes follow the "red-to-yellow" motif, you could be in trouble, even if you don't feel any immediate pain.
The venom from the coral snake can take up to 18 hours to start showing itself or it could hit you right away. Left untreated, the venom can kill by shutting down a victim's lungs.
The good news is that there is antivenin for coral snake bites. The bad news is that the one manufacturer that made the stuff is no longer making it. Come October, the last batch of coral snake antivenin hits its expiration date.
The problem with manufacturing the antivenin is that so little is used through the course of a year it isn't profitable for drug companies to invest millions into studies, tests and manufacturing.
The Food and Drug Administration will test the existing antivenin batch in October and could grant permission to administer it for another year, giving researchers more time to come up with an alternative, said Cynthia Lewis-Younger, medical director of the Florida Poison Information Center in Tampa.
The Florida Poison Information Center is creating an informational Web page on the subject and is expected to post it on its website by the end of this week, Lewis-Younger said.
"We believe it is likely that the existing (antivenin) lot will be extended for another year," she said, "however, at some point, probably next year, we will have exhausted all that antivenin."
Lewis-Younger said medical care providers are concerned about the antivenin issue but hopeful another antivenin will be developed to take its place. She said researchers currently are working on three possible alternatives, including Coralmyn, which is the most likely antivenin to take the place of the existing one. None of the alternatives have been approved by the FDA.
The problem lies in the cost to develop a vaccine that isn't used that often, she said. The national average is about 100 coral snake bites a year, Lewis-Younger said.
"The risk, if you don't get treatment, is that you may die," she said. "If you do go into a hospital and don't get the antivenin, you may end up on ventilator for many weeks.''
"It's not a good alternative," she said, "and it's much more expensive than having the antivenin."
Coral snake bite victims go through at least three 10 milliliter vials of antivenin. Each vial costs $1,560, she said.
Over the past 10 years, she said, Florida has led the nation in coral snake bites with an average of just under 50 a year. Still, that's not a significant number.
"It's a pretty rare bite," she said. Florida's coral snake bites usually are in the central part of the state, including Hillsborough and Polk counties. She called the area "a hotbed of where bites occur."
The existing coral snake antivenin that is about to expire was made by Wyeth Pharmaceuticals, which recently merged with Pfizer.
"Wyeth Pharmaceuticals no longer manufactures the antivenin and there is no alternative product licensed in the U.S. for coral snake bites," the FDA said in an advisory issued in January.
In July 2009, an FDA advisory board gave Coralmyn, the most likely alternative, a fast-track for accelerated approval, but no manufacturers have stepped up to invest up to $5 million for the required studies.
Reporter Keith Morelli can be reached at (813) 259-7760
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RE: Coral snake antivenin supply in danger of runn
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by AquaHerp on May 17, 2010
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Nobody is going to be deprived of coral snake antivenom if bitten.
More hype.
DH
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RE: Coral snake antivenin supply in danger of runn
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by venominme on May 17, 2010
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The last batch manufactured had an expiration date of October, 2008, which obviously has been extended twice with approval. Now they are submitting for a third extension. Some doctors will refuse to use the expired product. In fact, some refused to use antivenom even when it was brand new due to somewhat unfounded fears of using a whole IgG product (Wyeth) because of alergic reactions. So they will use nothing. I have self immunized with coral snake and can tell you just anecdotally, I tried death adder venom and had very good cross protection. Not to start any SI thread, just saying, it would seem that any acetylcholinesterase inhibiting-type venoms (death adder, Tiger snake, etc) antivenom would probably work just as well. Better than nothing, any way.
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RE: Coral snake antivenin supply in danger of runn
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by AquaHerp on May 18, 2010
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Coralmyn is available in the event of an emergency. No doctor will refuse the use of antivenom in a life-threatening situation. Reactions can be managed with routine drugs.
DH
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RE: Coral snake antivenin supply in danger of runn
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by JoeCrotalid on June 7, 2010
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To Date, 3 alternative antivenins have been studied in animal models-Coralmyn (Mexico), Anticoral (Costa Rico) and Tigersnake (Australia). Anticoral was shown to neutralize more venom per vial than the Wyeth product, next was the Coralmyn, and last-the Tigersnake antivenin was equal to the Wyeth product but no better. Coralmyn has been chosen because it has already been granted an Orphan drug status.
Currently, the Florida Poison Center is working with Pfizer (formly Wyeth) to get all remaining Wyeth products out to the hospitals instead of in a warehouse where they do no good which is estimated to be around 500 vials or more, and the FDA is currently considering another extension of the expiration date. The Florida Poison Center is working hard with hospitals and Pfizer on this issue, and in order to maintain supplies is only recommending administration if patients begin to exhibit signs or symptoms. No studies have ever been done to determine dry bite % which is estimated at about 20-40%. In fact, very few studies on Coral snake envenomations including dry bite percentage, untreated fatality, etc. have ever been done pre or post antivenin era. Only 2 deaths were atributed to the Eastern Coral snake prior to antivenin, and 1 death in 2009 of a victim who did not seek treatment. Retrospective reviews of records do show many cases not treated with antivenin who did not develop symptoms.
The other thing to consider is that patients can be managed without antivenin altogether by being intubated and placed on ventilators. However, this is something the Florida Poison Center is trying to prevent because of variety of issues...prolonged time on vent in ICU, financial costs of care, patient's requiring Trachs due to long ventilator care, potential for decubitus ulcers, and developing ventilator aquired pneumonia to name a few.
The Florida Poison Center has taken the lead on the antivenin issue, and is currently working Bioclon and various hospitals to start safety syudies for administering Coralmyn in efforts to gain FDA approval. While Miami-Dade has stocks of Coralmyn available in an emergency, it should be noted that the administration of a non-FDA approved antivenin while an FDA approved antivenin is available does raise legal issues. However, protocols are being developed by the Florida Poison Center to cover administration if needed. And YES! There are physicians who refuse to administer antivenin FDA approved or Not!
As the lead Snakebite Specialist forr the Florida Poison Center-Tampa, I invite you to check out the web page which is now up and running. www.poisoncentertampa.org and click on red box titled Coral Snake Antivenin.
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