Recalled Digitek Pills Linked with Severe Adverse Reactions
The Food and Drug Administration (FDA) issued a class I recall – the most severe FDA recall – in April 2008 for under-fire heart drug Digitek. The recall follows reports of severe adverse reactions linked with over-dosed Digitek pills. The recalled pills are believed to carry twice the recommended strength and run the risk of causing an overdose in the form of digitalis toxicity.
Digitek Pills Marketed Under Bertek and UDL Brand Names
Digitek is the trade name for digoxin or digitalis, a heart drug commonly used in the treatment of irregular heart rhythms (arrhythmia) or congestive heart failure. Manufactured by Actavis Totowa, Digitek has been marketed by Mylan Pharmaceuticals and UDL Laboratories under the brand names “Bertek” and “UDL.”
As brands of Digitek, Bertek and UDL have been included in the recall. Patients taking Bertek and UDL should consult with their physician about getting an alternative medication.
Digitek and Digitalis Toxicity
The Digitek recall was issued in response to reports of digitalis toxicity affecting patients taking the prescribed dosage of Digitek. The recalled Digitek pills may contain twice the intended amount of digoxin, yielding the potential for overdose and corresponding adverse effects. Actavis Totowa has claimed that this oversight could have resulted from pills being manufactured with twice the appropriate thickness, yielding a corresponding increase in digoxin levels.
Symptoms of digitalis toxicity may include dizziness, nausea/vomiting, low blood pressure and arrhythmia. One lawsuit filed by a digitalis toxicity victim claimed low heart rate, speech problems, confusion and blindness. The victim also suffered severe heart damage and required the placement of a pacemaker to regulate heartbeat. A number of other federal lawsuits have been filed by Digitek injury victims, including one wrongful death claim in which the victim died as a result of the overdose.
Actavis Totowa has acknowledged a number of pending defective drug lawsuits related to Digitek injuries. Reports have intimated that FDA inspections of an Actavis manufacturing plant discovered a number of questionable production practices that may have resulted in the negligent production of hazardous doses of Digitek.
If you or a loved one has been injured as a result of using Digitek, you may be entitled to receive compensation for your pain and suffering. Digitek users have suffered severe adverse reactions, some of which required hospitalization, and at least one of which resulted in death.
Drug manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for public consumption. Failure to do so is considered negligent and grounds for personal injury litigation. The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. They have successfully represented and obtained substantial compensation for a number of patients who have been harmed by drugs. Contact AWKO law today at 888 255 2956 to get more information about your rights as a Digitek injury victim.