May 16, 2008
Digitek® Safety Warning and Recall Notification
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.
Additional information regarding AMDUCA, this safety warning and the recall notification maybe found at the following FDA website links:
AMDUCA
Safety Alert
Recall Press Release
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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