CORAL SNAKE & ANTIVENOM FAQ’s
Why is there shortage of coral snake antivenom?
Pfizer/Wyeth has been the sole producer of antivenom in the United States. They no longer are manufacturing it. When present stocks are gone there, will be no FDA-approved antidote for coral snake bites.
How much Antivenom is available?
About coral snakebites:
About snakebite toxicity: What happens when a person is bitten?
The neurotoxic effects of the coral snake venom are manifested by muscle weakness,difficulty speaking, difficulty swallowing, difficulty breathing, unable to move eyelids (ptosis), blurred vision (diplopia), tongue fasciculations (twitching), decreased oxygen saturation, paralysis, and potential respiratory arrest. A patient may face weeks of ventilator support with subsequent pneumonia, tracheotomy and multi-system failure. Long term rehabilitation may be needed for neuromuscular damage. Prophylactic use of antivenom, which has long been the recommendation of poison centers, has been effective in preventing these signs and symptoms. Case reports of patients in which antivenom was delayed show that symptoms can progress to paralysis over a 12-18 hours period. In the last 40 years, there has been one fatality reported when a person failed to seek medical treatment after a bite.
What does the bitten area (bite site) look like?
About treatment of coral snakebites
About medical treatment: How effective is the antivenom treatment?
About eastern coral snakes:
How many bites occur each year?
How can the eastern coral snake be identified?
Where are coral snakes found?
What is the Latin name and classification for eastern coral snakes?
What’s being done about the antivenom shortage?
Managing and distributing remaining Antivenin(Micrurus fulvius)® supply:
- At the request of the FDA, Wyeth (now a subsidiary of Pfizer, Inc) made a five year supply of antivenin in preparation to allow a transition to another product. That supply was to have expired in 2008. Since 2008, Wyeth has been testing the remaining supply of lot #4030026 and obtaining FDA approval to extend the expiration date annually. In April, Wyeth obtained approval to extend the expiration date on lot #4030024.
- Florida Poison Information Center – Tampa has been conducting a antivenom inventory of its hospitals to determine the level of supply and provide information to pharmacists as needed.
- Florida Poison Information Center -Tampa has established a cooperative working relationship with Pfizer, Inc. to ensure a regional response that protects the potential snake bite victims and maximizes the availability of the Antivenin(Micrurus fulvius)®in those areas where it is most needed.
Educating health care providers and health care facility employees:
- Florida Poison Information Center – Tampa provided on-site professional education programs regarding this issue throughout its region to address this issue.
- Florida Poison Information Center- Tampa routinely notifies regional hospital pharmacies regarding the continuing availability of Antivenin (Micrurus fulvius)®.
- Florida Poison Information Center – Tampa provides this webpage as a service to provide needed information regarding the situation.
Outreach to the public:
Florida Poison Information Center – Tampa posts information on this website that is accessible to the public.
Securing a new supply of antivenom:
- Wyeth restarted the manufacturing process, and is planning to reintroduce Antivenin (Micrurus Fulvius) ®. It is unknown how soon a new supply will be available.
- Studies have been conducted to determine if antivenoms made in other parts of the world might work for envenomation by North American coral snakes. It has been determined that antivenoms made in Mexico, Costa Rica and Australia are likely to be effective.
- In January 2009, the National Institute of Health’s Office of Rare Diseases held a Coral Snake Antivenom Conference to discuss alternatives for addressing the discontinuation of the Antivenin (Micrurus Fulvius) ®.
- In July 2009, the FDA’s Blood Products Advisory Committee Meeting made recommendations to the FDA regarding the need to consider alternative routes to drug approval for a replacement antivenom.
- A study with an alternate antivenin was developed cooperatively between the VIPER Institute of the University of Arizona and the Florida Health Sciences Center, Inc (Tampa General Hospital) to test an alternative antivenom (INA2013). This study has been approved by the Florida Department of Health Institutional Review Board.