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Digitek®/Bertek®
According to the recall press release for Digitek® (digoxin tablets, USP, all strengths), the FDA has received several reports of injuries and illnesses associated with Actavis’ (distributed by Mylan Pharmaceuticals and UDL Laboratories Digoxin tablets) recalled drug Digitek® and/or Bertek. Apparently, Digitek® tablets with double strength active ingredients may have been commercially released.
Digitek® is used to treat heart failure and abnormal heart rhythms. 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.
The existence of double strength Digitek® tablets may lead to a potentially fatal condition known as digitalis toxicity in patients with renal failure. Digitalis Toxicity can cause a patient’s blood pressure to drop to dangerously low levels resulting in death and may also be associated with some of the following:
- Excessive, rapid weight gain
- Edema (swelling)
- Shortness of breath (dyspnea)
- dizziness
- nausea
- vomiting
- cardiac instability
- hallucinations
- seizures
- visual changes
- changes in color perception
- bright spotsblind spots
- blurred vision
- Palpitations
- Irregular pulse
- bradycardia
- loss of consciousness
- Loss of appetite
- Decreased urine output
- Excessive nighttime urination
- Cold sweats
- Difficulty breathing when lying down
- Death
U.S. FDA NOTICE
On April 25, 2008, the FDA and Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, initiated a Class I 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.
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