Double-Strength Digoxin Recalled

The FDA announced on April 28, 2008 that Actavis Totowa would begin a Class I recall of Digitek®. Digitek® is distributed by Mylan Pharmaceuticals label “Bertek” and by UDL Laboratories. The recall began after tablets double the appropriate thickness were discovered. These tablets may be double-strength and contain twice the approved amount of digoxin, the active ingredient.

Digoxin, also known as digitalis, is a purified cardiac glycoside extracted from the foxglove plant Digitalis lanata. Currently digoxin is marketed under the brand names Digitek® and Lanoxin®. Digoxin is used to treat abnormal heart rhythms such as atrial flutter and atrial fibrillation. It is also used as a second line agent in the treatment of heart failure.

A patient receiving a doubled dose of digoxin after ingesting a recalled tablet is at serious risk for digitalis toxicity. This risk is increased in patients with renal failure. Common signs of digitalis toxicity include nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia, and even death. Several reports of toxicity stemming from administration of the double-strength tablets have been reported and none of these have resulted in serious injury or death.

Pharmacists who have this product are encouraged to return the stock to the place of purchase and notify any patients who may have the recalled tablets in their possession. Adverse reactions associated with Digitek® should be reported to the FDA’s MedWatch Program.

References:
1. www.fda.gov
2. Actavis Pharmaceutical Press Release. April 25, 2008

Katie Priddy, PharmD. Candidate