[DANG! And we have 'em here in AZ...]
Why Snakebites Are About to Get a Lot More Deadly
By Glenn Derene
The cure for North American coral snake bite is about to disappear. Why an unprofitable anti-venom may end up costing lives.
As venomous snakes go, the coral snake is a clumsy biter. Unlike pit vipers such as rattlesnakes and cottonmouths, which have gruesomely efficient fangs that articulate forward during a strike and inject venom like hypodermic needles, the brightly colored coral snake has small, rear-facing fangs that guide venom into a wound. This process doesn't always work well--experts estimate that 25 percent of coral snake envenomations are dry bites--which is perhaps why the coral is so unaggressive. The snake is found throughout Florida, as well as in parts of Alabama, South Carolina, Louisiana, Texas and Arizona, but there are generally only about 100 or so bites each year.
SNIP
Unfortunately, after Oct. 31 of this year, there may be no commercially available antivenom (antivenin) left. That's the expiration date on existing vials of Micrurus fulvius, the only antivenom approved by the Food and Drug Administration for coral snake bites. Produced by Wyeth, now owned by Pfizer, the antivenom was approved for sale in 1967, in a time of less stringent regulation.
Wyeth kept up production of coral snake antivenom for almost 40 years. But given the rarity of coral snake bites, it was hardly a profit center, and the company shut down the factory that made the antivenom in 2003. Wyeth worked with the FDA to produce a five-year supply of the medicine to provide a stopgap while other options were pursued. After that period, the FDA extended the expiration date on existing stock from 2008 to 2009, and then again from 2009 to 2010. But as of press time, no new manufacturer has stepped forward.
Antivenom shortages are a surprisingly common occurrence. The entire state of Arizona ran out of antivenom for scorpion stings after Marilyn Bloom, an envenomation specialist at Arizona State University, retired in 1999. Bloom had been single-handedly making all the scorpion antivenom for state hospitals. Recently, Merck & Co, the only FDA-licensed producer of black widow antivenom, has cut back distribution because of a production shortage of the drug. In a 2007 report, the World Health Organization listed worldwide envenomations as a "neglected public health issue."
New scorpion and black widow antivenoms are currently in the pipeline, thanks to efforts by several poison-control associations to speed foreign drugs into the market through FDA research programs. There is also a coral snake antivenom produced by Mexican drug manufacturer Instituto Bioclon that researchers believe could be even more effective and safe than the outgoing Wyeth product. But that drug, Coralmyn, is not currently licensed for sale by the FDA. The tests required for licensing would cost millions of dollars, and for such a rare treatment (there are 15 times as many scorpion stings per year as coral snake bites), it could take decades for Bioclon to make its money back.
Envenomation experts express exasperation and disbelief at the situation. "It's ridiculous that we're losing a technology that we already have," says Joe Pittman, a snakebite treatment specialist at the Florida Poison Information Center in Tampa. "It's even more ludicrous that we have a product that's available, and we have to jump through so many hoops to get it approved." In July 2009, an FDA advisory board determined that Coralmyn qualified for an accelerated approval process, but there is still no one with the estimated $3 million to $5 million to pay for the required studies.
SNIP
rest of article HERE:
Why Snakebites Are About to Get a Lot More Deadly
By Glenn Derene
The cure for North American coral snake bite is about to disappear. Why an unprofitable anti-venom may end up costing lives.
As venomous snakes go, the coral snake is a clumsy biter. Unlike pit vipers such as rattlesnakes and cottonmouths, which have gruesomely efficient fangs that articulate forward during a strike and inject venom like hypodermic needles, the brightly colored coral snake has small, rear-facing fangs that guide venom into a wound. This process doesn't always work well--experts estimate that 25 percent of coral snake envenomations are dry bites--which is perhaps why the coral is so unaggressive. The snake is found throughout Florida, as well as in parts of Alabama, South Carolina, Louisiana, Texas and Arizona, but there are generally only about 100 or so bites each year.
SNIP
Unfortunately, after Oct. 31 of this year, there may be no commercially available antivenom (antivenin) left. That's the expiration date on existing vials of Micrurus fulvius, the only antivenom approved by the Food and Drug Administration for coral snake bites. Produced by Wyeth, now owned by Pfizer, the antivenom was approved for sale in 1967, in a time of less stringent regulation.
Wyeth kept up production of coral snake antivenom for almost 40 years. But given the rarity of coral snake bites, it was hardly a profit center, and the company shut down the factory that made the antivenom in 2003. Wyeth worked with the FDA to produce a five-year supply of the medicine to provide a stopgap while other options were pursued. After that period, the FDA extended the expiration date on existing stock from 2008 to 2009, and then again from 2009 to 2010. But as of press time, no new manufacturer has stepped forward.
Antivenom shortages are a surprisingly common occurrence. The entire state of Arizona ran out of antivenom for scorpion stings after Marilyn Bloom, an envenomation specialist at Arizona State University, retired in 1999. Bloom had been single-handedly making all the scorpion antivenom for state hospitals. Recently, Merck & Co, the only FDA-licensed producer of black widow antivenom, has cut back distribution because of a production shortage of the drug. In a 2007 report, the World Health Organization listed worldwide envenomations as a "neglected public health issue."
New scorpion and black widow antivenoms are currently in the pipeline, thanks to efforts by several poison-control associations to speed foreign drugs into the market through FDA research programs. There is also a coral snake antivenom produced by Mexican drug manufacturer Instituto Bioclon that researchers believe could be even more effective and safe than the outgoing Wyeth product. But that drug, Coralmyn, is not currently licensed for sale by the FDA. The tests required for licensing would cost millions of dollars, and for such a rare treatment (there are 15 times as many scorpion stings per year as coral snake bites), it could take decades for Bioclon to make its money back.
Envenomation experts express exasperation and disbelief at the situation. "It's ridiculous that we're losing a technology that we already have," says Joe Pittman, a snakebite treatment specialist at the Florida Poison Information Center in Tampa. "It's even more ludicrous that we have a product that's available, and we have to jump through so many hoops to get it approved." In July 2009, an FDA advisory board determined that Coralmyn qualified for an accelerated approval process, but there is still no one with the estimated $3 million to $5 million to pay for the required studies.
SNIP
rest of article HERE: