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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.
  • 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?

    
 

Contact Us

  • Consumer Affairs Branch (CBER)

  • (800) 835-4709
  • (301) 827-1800
  • ocod@fda.hhs.gov
  • Division of Communication and Consumer Affairs

    Office of Communication, Outreach and Development

    Food and Drug Administration

    1401 Rockville Pike

    Suite 200N/HFM-47

    Rockville, MD 20852-1448

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