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FL Press: Coral snake antivenin supply

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Posted by: W von Papinešu at Tue May 18 06:40:11 2010  [ Report Abuse ] [ Email Message ] [ Show All Posts by W von Papinešu ]  

TAMPA TRIBUNE (Florida) 17 May 10 Coral snake antivenin supply in danger of running out (Keith Morelli)
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.
Coral snake antivenin supply in danger of running out


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