In the first federal suit filed over Digitek, Bobbie Dyal and Robert Dyal, from Talladega, Alabama are suing Actavis Totowa the maker of a heart drug Digitek, which was used to treat heart failure and abnormal heart rhythms.
In April 2008, Actavis recalled all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP, all strengths) for oral use due to a manufacturing defect. The Food & Drug Administration (FDA) said the Digitek defect could expose users to twice the amount of the active ingredient digoxin, which could cause serious and even fatal reactions. The FDA received several reports of illnesses and injuries in patients taking Digitek; Actavis said it received 11 such reports. The defective tablets contained amounts of digoxin exceeding the dose indicated on the medication’s label and, in some cases, exceeded the dose approved for medical treatment in humans.
In their suit, the Dyals claim that defective Digitek pills caused Bobbie Dyal to suffer permanent heart damage attributed to digitalis toxicity, a lethal reaction to digoxin overdose. The suit states that Bobbie Dyal began having symptoms March 21 and was later flown by helicopter to Trinity Hospital, where she remained for nearly two months, until May 5. Bobbie Dyal underwent surgery to receive a pacemaker, according to the suit. Also according to the suit, Bobbie Dyal’s injury occurred a few weeks before the FDA announced the national recall.
Digitek was manufactured by Actavis Towtowa and sold by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. Digitek is a form of digitalis, a chemical derived from the foxglove plant that has been used as a heart medicine since the 18th century. Several companies sell the medication generically as digoxin.
Digitalis medicines strengthen the force of the heartbeat by increasing the amount of calcium in the heart’s cells. When the medicine reaches the heart muscle, it binds to sodium and potassium receptors. These receptors control the amount of calcium in the heart muscle by stopping the calcium from leaving the cells. As calcium builds up in the cells, it causes a stronger heartbeat. Digitalis medicines also control irregular heart rhythms (called arrhythmias) by slowing the signals that start in the sinoatrial (SA) node. This, in turn, reduces the number of signals that travel through the atrioventricular (AV node). Fewer signals mean fewer arrhythmias.
Actavis recalled its Digitek tablets because there existed a possibility that tablets with double the appropriate thickness might have been commercially released. The FDA deemed the Digitek recall a Class I recall, meaning that the defective Digitek tables could cause serious health problems or death. A double-strength Digitek tablet poses a serious risk of digitalis toxicity in those patients suffering from renal failure. Digitalis toxicity can cause nausea; vomiting; diarrhea; dizziness; confusion; loss of appetite; low blood pressure; cardiac instability and irregular pulse; heart palpitations; and bradycardia, a slower than normal heartbeat rate.
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