Information for Health Care Professionals: Anticipated Short Supply of Coral Snake Antivenom (Pfizer Inc. )
Posted Nov 18 2010 7:15am
May 18, 2010
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, Pfizer Inc. (formerly Wyeth Pharmaceuticals) is no longer making Coral Snake Antivenom, and there is no U.S.-licensed alternative supplier. Based on annual usage, FDA expects that supplies of in-date lot 4030026 will be sufficient at least until September-October 2010 and possibly longer. However, 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
If you have a patient with probable or definite Coral Snake envenomation and do not have Coral Snake Antivenom available at your institution, you may obtain assistance from the following:
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
You may consider using an investigational (non-licensed) imported Coral Snake Antivenom. These are available in some regions, under an Investigational New Drug (IND) protocol with informed consent. The Poison Control Centers may assist you in locating IND supplies of antivenom.
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 301-443-1240.
If Coral Snake Antivenom is Not Available
Your Poison Control Center can assist you with patient management.