October 25, 2011
This information is intended to alert health care professionals about the anticipated short supply of Antivenin (Micruris fulvius) (Equine), commonly referred to as North American Coral Snake Antivenom.
Licensed Coral Snake Antivenom Supplies
The manufacturer, Wyeth Pharmaceuticals (a subsidiary of Pfizer, Inc.) is no longer making Coral Snake Antivenom, and there is no U.S.-licensed alternative supplier. In the setting of diminishing supplies and unpredictability of where any given envenomation will occur, local and regional shortages are possible and will become more common over time as supplies are consumed or expire. Pfizer Inc. is carefully managing inventories of Coral Snake Antivenom and supplies product only to direct customers on a replacement or emergency basis.
How to Obtain Licensed Coral Snake Antivenom for an Envenomated Patient
- Your Poison Control Center at 800-222-1222. Poison Control Centers will assist you in evaluating the patient, and locating nearby hospitals that have Coral Snake Antivenom.
- Pfizer Inc. at 800-666-7248 between the hours of 8 AM and 8 PM (EST). Pfizer Inc. representatives are trained to handle expedited shipping for emergency requests.
If Licensed Coral Snake Antivenom is Not Locally Available or Not Available in a Timely Fashion
- Use of IND products requires informed consent under the existing IND if your patient is eligible under that IND protocol.
- Alternatively, you may request use of the IND product as an emergency IND for single patient use by calling FDA:
- Business hours – 800-835-4709 or 301-827-1800
- Nights/holidays/weekends FDA emergency operations at 301-796-8240.
If Coral Snake Antivenom is Not Available
- Your Poison Control Center can assist you with patient management.
- We request that you report the shortage to FDA at: CBERshortages@fda.hhs.gov or by calling 301-827-4239.
What is being done to Alleviate or Prevent Short Supply of Coral Snake Antivenom?
- FDA, Poison Control Centers, and Pfizer Inc. are working together to monitor supplies and to provide information to Health Care Providers.
- FDA has extended the expiration date for lot 4030026 until October 31, 2012, based on stability data provided by Pfizer Inc. FDA will evaluate additional stability data as it becomes available, to support further expiration date extensions. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm155092.htm
- Poison Control Centers are available to assist in locating Coral Snake Antivenom and in providing management advice to healthcare providers.
- Pfizer Inc is allocating supplies and shipping directly to customers.
- FDA has mechanisms in place to allow importation of investigational products for treatment of envenomations. (http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/