Digitek heart drug recalled.Actavis Totowa notified health care professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals under a "Bertek" label and by UDL UDL Universal Design for Learning UDL Universitat de Lleida (Spain) UDL Universal Data Link UDL Urban Debate League UDL Uniformly Distributed Load (mechanics, building trade) UDL User Defined Logic Laboratories under a "UDL" label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient. . The existence of double strength tablets poses a risk of digitalis toxicity digitalis toxicity Digoxin toxicity Cardiology Clinical findings of digoxin overdose Clinical Loss of appetite, N&V, defects in color vision–reds and greens, or seeing halos around lights, psychotic changes, weakness, fatigue, or dizziness; new onset of in patients with renal failure renal failure n. Acute or chronic malfunction of the kidneys resulting from any of a number of causes, including infection, trauma, toxins, hemodynamic abnormalities, and autoimmune disease, and often resulting in systemic symptoms, especially edema, . Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia bradycardia: see arrhythmia. . Several reports of illnesses and injuries have been reported. Patients should contact their health care professional with questions. Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.h tm-Digitek |
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