On April 28, 2008 Actavis Totowa LLC notified healthcare professionals of a Class I national wide recall of all strengths of Digitek. According to the FDA, the product was being recalled after the discovery that some of the “tablets with double the appropriate thickness may contain twice the approved level of active ingredient.”
Digitek, commonly known as Digitalis or Digoxin, is a drug manufactured by Actavis Towtowa (formerly known as Amide Pharmaceutical, Inc.) and sold by Mylan Pharmaceuticals Inc., to treat mild to moderate heart failure. Digoxin is derived from the leaves of a digitalis plant, and helps make the heart beat stronger and with a more regular rhythm. It was approved by the FDA on December 23rd of 1999. Since then, it has been used to treat patients with heart failure and abnormal heart rhythms.
The recommended dosage of Digoxin requires careful attention because of individual sensitivity of patients’ to the drug. Some of the factors to be considered are a patients’ body weight, renal function, age, and concurrent medications.
After its approval in 1999, the FDA sent warning letters to Actavis in September 2006 and February 2007 after it was found that the drug maker’s plant in Little Falls had manufacturing problems.
The adverse reactions to Digoxin are dose related and often occur when an excess amount of the active ingredient is ingested. As a result, Digitek at twice the approved level could lead to serious complications and poses a risk of Digitalis toxicity in patents with renal failure. Digoxin is primarily excreted by the kidneys; therefore, patients with impaired renal function require smaller than usual doses of digoxin. Some of the symptoms of Digitalis toxicity are:
- low blood pressure
- cardiac instability
- bradycardia (slower heartbeat rate).
- heart attack
- heart failure
Further, vision changes such as blurred or yellow vision, light rings around objects, seeing lights and bright colors, experiencing changes in color perception, can also occur. Patients suffering Digitalis toxicity can also experience decreased urine output and excessive nighttime urination, overall swelling, decreased consciousness, and difficulty breathing when lying down. Occasionally, death can result from excessive Digitalis intake.
On August 1, 2008 Actavis Totowa announced a voluntary recall of all drug products manufactured at its Little Falls, New Jersey facility following an inspection conducted by the Food and Drug Administration earlier this year.
There have already been hundreds of reports from Digitek users who have experienced digitalis toxicity.
If you or a loved one has a medical history of renal failure, and has experienced adverse side effects while taking Digitek, call or contact us to represent your interests in a Digitek lawsuit. At Oshman & Mirisola our experienced Digitek attorneys will provide you with aggressive representation in the handling of your case. We offer a FREE, no-obligation consultation with a Digitek lawyer so that you can learn more about your legal rights and options.