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U.S. Department of Health and Human Services

Animal & Veterinary

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Digitek® Safety Warning and Recall Notification

May 16, 2008

Veterinarians who use the human drug Digitek® (digoxin tablets, USP) to treat their patients should be aware of the possibility that the tablet strength may be doubled in the product.  This increase in tablet active ingredient could result in life-threatening adverse drug reactions in some animals.  Digoxin is used in both humans and animals for the treatment of various heart conditions, namely atrial fibrillation, atrial flutter and sometimes heart failure that cannot be controlled by other medication.  Under the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) veterinarians are allowed to prescribe extralabel uses of certain approved animal drugs and approved human drugs for animals under certain conditions.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855