DIGITEK

In April 2008, the Iceland based drug company, Actavis Towtowa, recalled all lots of Bertek and UDL Laboratories Digitek (digoxin tablets) for oral use due to a manufacturing defect.

The Food and Drug Administration (FDA) said the Digitek defect could expose users to twice the amount of active ingredient, which could cause serious and even fatal reactions. The FDA received several reports of illnesses and injuries in patients taking Digitek. Actavis said it had 11 such reports. But because not all adverse reactions are reported to the FDA or manufacturers, we believe that there are far more victims of this defective drug.

Digitek, manufactured by Actavis Towtowa, is sold by Mylan Pharmaceuticals under a “Bertek” label and by UDL Laboratories, 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. The medication is sold generically as digoxin by several companies.

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.

Digitalis toxicity is a complication of digitalis therapy. Digitalis toxicity can occur from a single exposure or chronic overmedication. People with heart failure are commonly given diuretics (medications used to pull excess fluid from the body) along with digoxin. Many diuretics can cause potassium loss. Low levels of potassium in the body increase the risk of digitalis toxicity. Digitalis toxicity may also result from low levels of magnesium in the body. Reduced kidney function will cause digitalis to accumulate in the body rather than being excreted normally through urine. Therefore, any disorders that disrupt kidney functioning (including dehydration) make digitalis toxicity more likely.

Digitek Recall

On April 25, 2008, Actavis Towtowa recalled its Digitek tablets because tablets with double the appropriate thickness may have been commercially released. The FDA deemed the Digitek recall a Class I recall, meaning that the defective Digitek tablets could cause serious health problems or death. Actavis’ failure to keep these Digitek tablets away from consumers constitutes an act of negligence.

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. Bradycardia is a slower than normal heartbeat rate.
Vision changes such as halos or light rings around objects, seeing lights and bright colors, experiencing changes in color perception, blind spots in vision, and blurred vision can also occur. Patients suffering digitalis toxicity can also experience decreased urine output and excessive nighttime urination, overall swelling, decreased consciousness, and difficulty breathing when lying down. At its most severe, death can result from excessive Digitalis intake.
 

Contact Us
The law office of Mark Davis is now handling claims for individuals who have suffered digitalis toxicity. Mark Davis, P.C. is experienced in pharmaceutical product liability cases and settlements. If you or a loved one has suffered digitalis toxicity, contact us at 1-800-277-0300 or send us an email at info@davisandfeder.com.