Digitek Digoxin Recalled Due to Manufacturing Defect

Digoxin, also known as Digitalis, Lanoxin, Digitek, and Lanoxicaps, is a refined plant extract, a purified cardiac glycoside (drugs used in the treatment of congestive heart failure and arrythmia). Digoxin is commonly marketed under the names Lanoxin, Digitek, and Lanoxicaps.

Digoxin has been used in the treatment of various heart conditions, namely atrial fibrilation and atrial flutter, both abnormal heart rhythms It is sometimes prescribed for heart failure that cannot be controlled by other medication. Antiarrhythmic agents are a group of pharmaceuticals that are used to suppress cardiac arrhythmias, such as atrial fibrillation, atrial flutter, ventricular tachycardia and ventricular fibrillation.

While the use of anti-arrhythmic agents to suppress atrial arrhythmia is still in practice, it is unclear whether suppression of atrial arrhythmia will prolong life. It was believed that following a heart attack, suppression of arrhythmia would prolong life, however large clinical trials found that suppression of these arrhythmia would paradoxically increase mortality. This may happen due to the pro-arrhythmic effect these drugs could potentially create in the patient.

The use of digoxin in heart problems during sinus rhythm(normal heart beat)was once standard, but is now controversial. While it appears that the increased force of contraction should lead to improved pumping function of the heart, its effect on prognosis is questionable; additionally, other effective treatments are available, making the use of the medication during sinus rhythm an unnecessary risk.

Nor is Digoxin the first choice for congestive heart failure, although it can still be useful in patients who remain symptomatic despite proper diuretic and ACE inhibitor(another pharmaceutical regimen) treatment. It has fallen out of favor because it was proven to be ineffective at decreasing the duration of heart disease, as well as in the reduction of numbers of deaths with regard to congestive heart failure. It has been shown to increase quality of life in some cases.

Digoxin is usually given by mouth, but can also be given by IV injection in urgent situations. The half life is about 36 hours; it is given once daily, usually in 125 g or 250 g dosing. In patients with decreased kidney function the half life is considerably longer, calling for a reduction in dosing or a switch to a different medication, such as digitoxin, a similar medication.

Common digoxin side effects can include: loss of appetite, nausea, vomiting, diarrhea, blurred vision, visual disturbances (yellow-green halos), confusion, drowsiness, dizziness, nightmares, agitation, and/or depression. Less frequent adverse effects include: acute psychosis, delirium, amnesia, and the possibility of life-threatening heart complications, including additional arrythmia episodes and heart failure. Additionally, Digoxin has been shown to be deadly in overdose situations.

Any patient who believes they may have been negatively affected by digoxin, whether it was marketed as Digitek or some other brand, should immediately contact a health professional to evaluate their condition.