While a voluntary recall of Digoxin (Digitek) was issued by Actavis Totowa in April 2008, by this time a number of cases of illness and medical events related to Digoxin (Digitek) had already been reported to the FDA (Food & Drug Administration). The FDA immediately sprung into action as this drug could cause serious health problems and even death to those who took this medicine, and classified this as a Class I recall.

Heart patients in the US who were getting treated for heart failure and abnormal heart rhythms complained of nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia and in some other cases even death was reported. It was further found out that the symptoms were more prevalent in those patients who were administered a drug called Digoxin which was being marketed under the registered trademark of Digitek owned by Actavis Totowa(formerly Amide Pharmaceutical, Inc.).This drug is distributed by Mylan Pharmaceuticals Inc., under a Bertek label and by UDL Laboratories, Inc. under a 'UDL' label.
Digitek starts working by taking a direct action on our cardiac muscle, in addition to this it also takes an indirect action on the cardiovascular system and the autonomic nervous system of our body.

The autonomic effects include: (1) a vagomimetic action, which is responsible for the effects of Digitek (Digoxin) on the sinoatrial and atrioventricular (AV) nodes; and (2) baroreceptor sensitization, which results in increased afferent inhibitory activity and reduced activity of the sympathetic nervous system and renin-angiotensin system for any given increment in the mean arterial pressure.

The pharmacologic consequences of these direct and indirect effects are: (1) an increase in the force and velocity of myocardial systolic contraction (positive inotropic action); (2) a decrease in the degree of activation of the sympathetic nervous system and renin-angiotensin system (neurohormonal deactivating effect); and (3) slowing of the heart rate and decreased conduction velocity through the AV node (vagomimetic effect).

The effects of Digitek (Digoxin) in heart failure are mediated by its positive inotropic and neurohormonal deactivating effects, whereas the effects of the drug in atrial arrhythmias are related to its vagomimetic actions. In high doses, Digitek (Digoxin) increases sympathetic outflow from the central nervous system (CNS). This increase in sympathetic activity may be an important factor in Digitek (digitalis) toxicity.

Digitek (Digoxin) is available in tablet, capsule, liquid, and injectable forms, however the Digitek recall relates only to the tablets. It has been found that these tablets contain twice the approved/recommended dosage of the medicine. Also the medical providers have ascertained that if these tablets are ingested, it can result in severe medical complications caused by digitalis toxicity, which is a medical condition which leads to very serious side effects which are nausea, vomiting, dizziness, low blood pressure, cardiac instability and even death.
The condition of Digitek Digoxin toxicity is found to be associated with a manufacturing defect from Digitek. It has also been found that the tablets may contain twice the approved or recommended levels of dosage. The tablets were also found with double the thickness which is appropriate for commercial release, making it a double-strength pill which led directly to a risk of Digitek toxicity which causes nausea, vomiting, low blood pressure, cardiac instability, bradycardia and even death.

To put is simply “Digitek (Digoxin) inhibits sodium-potassium ATPase, an enzyme that regulates the quantity of sodium and potassium inside the cells. Inhibition of the enzyme leads to an increase in the intracellular concentration of sodium and thus (by stimulation of sodium-calcium exchange) an increase in the intracellular concentration of calcium.”