Manufacturer: Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.)
Date approved: December 23, 1999
Status: Digitek-branded Digoxin recalled April 25,2008 due to the existence of double-strength tablets that pose a risk of digitalis toxicity in patients.
Approved uses: Treating heart failure and slowing the heart rate in patients with chronic atrial fibrillation, a type of abnormal heart rhythm.
Off-Label uses: None
• blurred vision
• breast development in males
• change in heartbeat
• loss of appetite
• lower stomach pain
• yellow vision
Digitek Digoxin Recall
Digitek, generic name Digoxin, is a heart medication previously prescribed to patients with congestive heart failure, certain types of irregular heartbeat, and other heart problems. It improves the strength and efficiency of the heart, which leads to better circulation of blood and reduction of the uncomfortable swelling that is common in people with congestive heart failure.
In an April 28, 2008 MedWatch Safety Alert about Digitek brand Digoxin tablets, the FDA informed doctors and patients that this prescription medication was the subject of a recent nationwide Class I recall because of the possibility that some tablets contain twice the Digoxin as approved by the FDA. The potentially dangerous tablets were produced as a result of a manufacturing error and as a result the recall covers all strengths of Digitek.
According to the FDA MedWatch Safety Alert, the recalled Digitek was distributed by Mylan Pharmaceuticals Inc., under a �Bertek� label and by UDL Laboratories, Inc. under a “UDL” label. Additionally the Safety Alert explained that the existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure and additionally can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia.
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 . It is widely 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. Digoxin is commonly marketed under the name Lanoxin, Digitek, and Lanoxicaps, and has been manufactured widely in the United States by the pharmaceutical company Actavis Totowa LLC, formerly known as formerly known as Amide Pharmaceutical, Inc. It is the New Jersey headquartered and United States based manufacturing division of the international pharmaceutical company Actavis Group, a well known manufacturer and distributor of generic versions of previously name-brand drugs.
On April 25, 2008, Actavis Totowa initiated a Class 1 nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals, Inc. under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. According to the Actavis website:
The voluntary all-lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than is appropriate.
Digitek Side Effects
The posting indicates, as do other reports, that both of the Mylan Pharmaceuticals laboratories(Bertek and UDL) incorrectly manufactured the Digitek pills with double the amount of active medicine, spiking the risk of side effects dramatically. Common side effects 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, Digitek has been shown to be deadly in overdose situations.
Indeed, several postings on consumer health and recall websites reflect the outrage over this egregious error. Reports of illnesses, complications and even deaths consistent with the relevant side effects of overdosing have been surfacing in the press over the last month. These reports, coupled with the Class 1 nationwide recall of all Digoxin tablets distributed by Mylan Pharmaceuticals, and the additional reports released by the FDA and other independent health care professionals lead to a sincere possibility of a Class Action or Mass Tort lawsuit. In fact, several law firms have already reported the beginnings of proceedings in such cases where overdoses from Digoxin have injured clients and caused dangerous, damaging, or deadly side effects.
Digitek Digoxin: Important Facts for Patients
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. It has been manufactured widely in the United States by the pharmaceutical company Actavis Totowa LLC, formerly known as Amide Pharmaceutical, Inc., the New Jersey headquartered and United States based manufacturing division of the international pharmaceutical company Actavis Group. Actavis Group prides itself on being a well known manufacturer and distributor of generic versions of previously name-brand drugs.
Digoxin is widely 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.
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. Additionally, patients may want to contact a digoxin law firm to help them better understand any potential digitek lawsuit that may be developed. To be put in touch with a qualified digitek lawyer, simply fill out the digoxin attorney contact form at the top of this page.