Digitek®/Digoxin

Digitek® is manufactured by Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company, Actavis Group, headquartered in New Jersey.  Actavis manufactures products for Mylan Pharmaceuticals and UDL laboratories. The products are distributed under the Bertek label by Mylan Pharmaceuticals, Inc., and under the UDL label by UDL laboratories, Inc.

Digitek®, the generic name for Digoxin, is also known as Digitalis, Cardoxin, Lanoxin, and Lanoxicaps. It is a refined plant extract, a purified cardiac glycoside, and is distributed as a medication prescribed for patients with heart problems like congestive heart failure, and irregular heartbeats.  Digoxin is usually given by mouth, but can also be given by IV injection in urgent situations.  The purpose of the medication is to help to regularize the heartbeat.  However, the double strength tablets reportedly pose a particular risk of digitalis toxicity in patients with renal failure due to the lack of ability of their body to excrete the drug.

There have been several reports of injuries, illness, and even deaths due to over-dosage of Digitek®.  On April 25, 2008, the FDA recalled the drug.  The Actavis Group is initiating a Class I nationwide recall of Digitek®, Bertex, and UDL for oral use.  The recall of the medication is due to the possibility that the Digoxin tablets were made with double the appropriate strength for a commercial release.  It is suspected that certain of the drugs may contain twice the approved level of its active ingredient, which can cause symptoms of digitalis toxicity that include nausea, confusion, vomiting, hallucinations, vision problems, low blood pressure, or abnormally fast or slow heartbeat.

If you or a loved one have been prescribed Digitek®, contact your health professional immediately.  To obtain confidential advice and counsel regarding the Digitek® recall at no cost, or to file a Digitek® defective pharmaceutical claim, contact the law offices of Capretz & Associates today. Our experienced attorneys can help you.