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Digitek, manufactured by Actavis Totowa, is used to strengthen the force of a heartbeat by increasing the amount of calcium in the heart's cells. When the medicine reaches the heart muscle, it binds to sodium and potassium receptors. This prevents them from releasing the calcium from the cardiac cells. As calcium builds up in the cells, it causes a stronger heartbeat. Digitek is also used to control irregular heart rhythms (called arrhythmias) by slowing the signals that originate in the sinoatrial (SA) node (your heart’s natural pacemaker). Fewer signals mean fewer arrhythmias.

In April 2008, Actavis Totowa recalled all units of Digitek. Following are the companies which sold the drug for Actavis Totowa, the labels they were sold under and the reason they were recalled:

COMPANY DRUG LABEL REASON
Mylan Pharmaceutical Inc. Bertek manufacturing defect
UDL Laboratories, Inc. UDL manufacturing defect

The Food & Drug Administration (FDA), after receiving several reports of illnesses and injuries in patients taking Digitek, stated the defect could expose users to twice the amount of active ingredient, which could cause serious and even fatal “digitoxicity” reactions. 

Digitoxicity is a complication of digitalis therapy and may be caused by an acute ingestion of digitalis. The harmful effect can occur from a single exposure or chronic overmedication.  Factors which increase your risk of digitoxicity are:

  • Use of Digitek along with diuretics (medications used to pull excess fluid from the body). Many diuretics can cause potassium loss, which in turn increases the risk of digitalis toxicity.
  • Reduced kidney function will cause digitalis to accumulate in the body rather than being excreted normally through urine. Therefore, any disorders that disrupt kidney functioning (including dehydration) make digitalis toxicity more likely.
  • Receiving more than the approved level of Digitek in one dosing.

The recall in April of 2008 was deemed Class I by the FDA. A Class I recall is the most serious type of recall and involve a situation where there is a reasonable chance that use of the product will cause serious injury or death. The following side effects may result from ingestion of an increased dosing:

  • nausea
  • vomiting
  • diarrhea
  • dizziness
  • confusion
  • loss of appetite
  • blurred vision, halos or light rings around objects, seeing lights and bright colors, changes in color perception, or blind spots
  • decreased urine output and excessive nighttime urination
  • overall swelling
  • decreased consciousness
  • difficulty breathing when lying down. 
  • low blood pressure
  • cardiac instability and irregular pulse
  • heart palpitations
  • bradycardia (slower than normal heart rate) 
  • death

Immediately contact a doctor if you or a loved one have experienced any of the above side effects associated with the use of Digitek.

You should also contact the North Carolina dangerous drug attorneys of Hardison & Associates . The skilled Raleigh personal injury lawyers of Hardison & Associates have represented clients who have been injured because of dangerous prescription drugs, including Digitek. Hardison & Associates have the resources to hire the necessary experts and investigators to fight big drug companies. Our experience and expertise can help you level the playing field. Contact our NC Digitek lawyers today.

At Hardison & Associates, we pride ourselves in giving quality legal service and exceptional client service. We are the North Carolina law firm with the 100% client service satisfaction guarantee. Do not delay -- there are time limits for bringing a legal action. Call us today at 1 (800) 434-8399 or contact us online.

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