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Author Topic: Recall of Digitek (digoxin)  (Read 397 times)
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Arlo
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« on: April 29, 2008, 07:54:52 AM »

http://www.fda.gov/oc/po/firmrecalls/actavis04_08.html

"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 it appropriate.

Digitek® is used to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received."
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5CatMom
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« Reply #1 on: April 29, 2008, 08:23:28 AM »

This makes me very angry!  Angry

What is wrong with these companies?  Just the same old "garbage in - garbage out" business plan.

And the bad news is that they continue to get away with it.

5CatMom
=^..^=
« Last Edit: April 29, 2008, 08:25:06 AM by 5CatMom » Logged

"What is man without the beasts? If the beasts were gone, men would die from a great loneliness of spirit. For whatever happens to the beasts, soon happens to man. All things are connected." Chief Seattle

"We are the caretakers of our creatures . . . the peacekeepers of our planet"
GoingNUTZoverthis
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« Reply #2 on: April 29, 2008, 10:45:13 AM »

Seeing another recall makes me paranoid for my moms surgery on the 6th, surgery is bad enough let alone having to worry about the meds being bad.  GEEZ
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kb
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« Reply #3 on: April 29, 2008, 09:05:29 PM »

Thank you, I'll be calling my mom first thing in the morning to find out what brand she takes. 
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3catkidneyfailure
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« Reply #4 on: May 20, 2008, 08:30:56 AM »

This from the CVM this morning for any of you treating fur-kids with an off-label use of Digitek:

http://www.fda.gov/cvm/CVM_Updates/DigitekSafetyRecall.htm
CVM Update
<<Back
May 16, 2008

Digitek® Safety Warning and Recall Notification

Veterinarians who use the human drug Digitek® (digoxin tablets, USP) to treat their patients should be aware of the possibility that the tablet strength may be doubled in the product.  This increase in tablet active ingredient could result in life-threatening adverse drug reactions in some animals.  Digoxin is used in both humans and animals for the treatment of various heart conditions, namely atrial fibrillation, atrial flutter and sometimes heart failure that cannot be controlled by other medication.  Under the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) veterinarians are allowed to prescribe extralabel uses of certain approved animal drugs and approved human drugs for animals under certain conditions. ...

cross-posted: http://itchmoforums.com/veterinary-and-medications/may-16-2008-veterinary-recall-of-digitek-for-extralabel-use-in-pets-t4902.0.html;new


« Last Edit: May 20, 2008, 08:37:05 AM by 3catkidneyfailure » Logged
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