Home : Unsafe Drugs : Digitek Digoxin
Digitek Digoxin
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.
Fast Facts
| Name: | Digitek |
| Generic: | Digoxin |
| 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 |
| Side effects: | Apathy, blurred vision, breast development in males, change in heartbeat, confusion, diarrhea, dizziness, headache, loss of appetite, lower stomach pain, nausea, psychosis, rash, vomiting, weakness, yellow vision |
| Related topics: |
