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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Dear Health Care Provider: Further Extension of Expiration Dating to April 2014, LOT NO.4030024 - North American Coral Snake Antivenin

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Pfizer, Inc.
235 East 42nd Street
New York, NY 10017 

December 7, 2012

Pfizer, Inc.
235 East 42nd Street
New York, NY 10017
 
Re: IMPORTANT PRODUCT SUPPLY INFORMATION
 
Antivenin (Micrurus fulvius) (Equine Origin) North American Coral Snake  Antivenin
 
FURTHER EXTENSION OF EXPIRATION DATING TO APRIL 2014
LOT NO.4030024
 
Dear Health Care Provider:

 
Wyeth Pharmaceuticals  (a subsidiary of Pfizer, Inc) would like to provide you with updated and very important information regarding Antivenin (Micrurus fulvius) (Equine Origin) North American Coral Snake Antivenin.
 
As you may know, Wyeth Pharmaceuticals no longer manufactures Antivenin, and there is currently no alternative FDA-approved supplier of this product.  In October 2012, Wyeth Pharmaceuticals announced  the extension of the expiration date of one lot of Antivenin, Lot No. 4030026, until October 31, 2013, an additional 60 months beyond the labeled expiration date of October 31, 2008.
 
Due to limited supply of Antivenin, Wyeth Pharmaceuticals,  working closely with the U.S. Food and Drug Administration (FDA), is extending the expiration date of a second lot of Antivenin, Lot No. 4030024, to April 2014.  Wyeth Pharmaceuticals has stability data that indicate product from Lot No. 4030024 continues to be within applicable specifications. Pfizer has made this second lot available for shipment.
 
Pfizer is carefully managing Antivenin (Micrurus fulvius) inventories and will supply product only to direct customers.

Antivenin (Micrurus fulvius) (Equine Origin) is indicated for the treatment of envenomation caused by the bites of M. f. fulvius (eastern coral snake) and M. f. tenere (Texas coral snake).

Patients sensitive to Antivenin or horse serum may develop anaphylaxis. Therefore, it is essential that prior to intravenous or intramuscular Antivenin administration a properskin test be performed, interpreted, and therapy modified if indicated.  Since the possibility of a severe immediate reaction (anaphylaxis) always exists whenever horse serum is administered appropriate therapeutic agents, such as tourniquet, oxygen supply, epinephrine1:1000, and another injectable pressor amine (notcorticosteroids) must be ready for immediate use.
 
Please see accompanying full Prescribing Information for indications and usage, dosage and administration, and important safety information. Also, the product Prescribing Informationcan be accessed at http://www.pfizer.com.
 
If you have any questions, please call our Customer Service Department at 1-800-666-7248.

Sincerely,

/s/

 

Salomon Azoulay, M.D.
Senior Vice President
Emerging Markets and Established Products
Medical & Development  Group
Pfizer, Inc.