Digitek (digoxin tablets)
Our firm continues to be at the leading edge of investigations into potential claims involving defective drugs. On April 25, 2008, Actavis Totowa LLC announced a Class 1 nationwide recall of the oral prescription medication Digitek (digoxin tablets, USP, all strengths) a medication prescribed for treatment of a variety of cardiac conditions including congestive heart failure and atrial fibrillation. Digitek is a generic drug that came to market after Digoxin went “off patent” and could be copied and sold in generic form. The medication helps the heart beat and contract more efficiently. Digitek is distributed by Mylan Pharmacueticals, Inc. under the “Bertek” label and by UDL Laboratories, Inc., under the “UDL” label. The oral medication is supplied in pill form in both 12.5 mg and 25 mg strengths.
The voluntary recall is due to the possibility that tablets with double the appropriate thickness may have been released to the public. Accordingly, some lots of Digitek tablets contained twice the level of the active ingredient digitalis. This dangerous double-strength dose creates a severe safety risk of developing digitalis toxicity. Symptoms of digitalis toxicity include nausea, vomiting, dizziness, low blood pressure, slowed heart rate and/or cardiac instability which can lead to heart failure, stroke, and even death. Patients using Digoxin in the past and who may have been switched to the generic Digitek or who were using any other prescription medication form of digitalis and were switched to Digitek should be aware of this manufacturing defect and its potentially harmful affects. Actavis maintains that none of the improperly manufactured Digitek pills ever reached the public.
The recall also followed an inspection by the FDA that revealed operations at the Little Falls, New Jersey, facility did not meet the FDA's or Actavis' standards for Good Manufacturing Practices. On August 1, 2008, Actavis issued a voluntary recall of all drug products manufactured at its Little Falls facility. In response, the U.S. House of Representatives Energy and Commerce Committee began an investigation in October of 2008 into the FDA's oversight of Actavis' drug manufacturing operations and asked the FDA to turnover all information relating to all FDA approved products for which Actavis had received approval since January 1, 2003. On November 14, 2008, the U.S. Department of Justice, on behalf of the FDA, filed a complaint seeking a permanent injunction against Actavis Totowa LLC and Actavis, Inc. as well as two of its officers for numerous and recurring violations of Good Manufacturing Practice requirements at its facilities in New Jersey and also for the manufacturing and distribution of unapproved new drugs. On December 29, 2008, Actavis announced that it reached an agreement with the FDA on a Consent Decree of Permanent Injunction regarding the company's Actavis Totowa LLC subsidiary. The New Jersey facilities affected by the Consent Decree are located in Little Falls, Riverview, and Taft. The Consent Decree confirms that Actavis has agreed not to distribute any products from the Actavis Totowa facilities until it has certified completion of certain requirements that demonstrate compliance with the FDA's Good Manufacturing Practice and has passed FDA inspections of its facilities.
A new report released in December of 2008 from The Center for Public Integrity (the Center) indicates that FDA records show that between April 1, 2008, and June 30, 2008, Digitek was cited by doctors and consumers as the primary suspect in the deaths of hundreds of patients in the United States. The FDA confirmed reports of 667 deaths reported to the Agency that health care professionals and consumers attributed to Digitek during that same time period.
The law firm of Alley, Clark & Greiwe is currently accepting clients who have ingested this medication and suffered injury or death. Any patient with a cardiac condition who suffered harm or any family of a patient who died in the recent past should check to see if this medication was being taken at the time of the adverse event.
Helpful Links:
Report - Criticism Mounts Over Digitek Recall (1/15/09)
Click here to view press release comment from Actavis on DOJ complaint
Click here to view The Center for Public Integrity report from December of 2008
