Consumers who use the drug Digitek for heart problems should be aware of a serious -- and potentially fatal -- manufacturing defect.
The manufacturer of Digitek recalled the product on April 28, 2008 after discovering that some tablets were released with double the normal thickness - and twice the approved level of the active ingredient.
Those double strength tablets may cause Digitalis Toxicity, the Food and Drug Administration has warned.
Digitalis Toxicity is a potentially fatal illness for people with impaired kidney function. The FDA has received several reports of illnesses and injuries.
Digitalis toxicity can lead to nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake.
Symptoms include: unusual visual changes such as blurred vision or blind spots; confusion; loss of appetite; heart palpitations; irregular pulse; decreased urine output or excessive nighttime urination; and difficulty in breathing while lying down.
Digitek was approved on December 23, 1999 to treat congestive heart failure and abnormal heart rhythms. Digitek is the brand name for digoxin tablets manufactured by Actavis Totowa LLC, the U.S. division of Actavis Group, the international generic pharmaceutical company. The drug is distributed by Mylan Pharmaceuticals, Inc. under the Bertek and UDL labels.
If you have any legal question regarding injury or death related to Digitek, contact the Florida drug injury lawyers at Gordon & Doner, P.A.
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