Digitek Recall
Digitek is a drug prescribed to patients who have experienced heart failure or have an abnormal heart rhythm. The drug's active ingredient makes the heart beat more strongly and at a more appropriate rhythm.
In April 2008 Digitek's manufacturer, Actavis Towowa LLC, issued a Class I recall of all Digitek tablets after it was discovered that some tablets may be twice the approved thickness and therefore contain twice the approved amount of the drug's active ingredient. This increased dose can lead to a form of poisoning called digitalis toxicity, especially in patients who have suffered kidney failure. In addition to Digitek, the drug is sold under the brand names Lanoxicaps and Lanoxin, and under its generic name: digoxin. Its distributors are Mylan Pharmaceuticals Inc. (Bertek label) and UDL Laboratories, Inc. (UDL label).
If you have experienced any of the symptoms outlined in the section below, contact your doctor immediately, as digitalis toxicity is a potentially fatal condition. For more information on the legal implications and Digitek lawsuits, contact an attorney specializing in personal injury lawsuits. The manufacturers and distributors of Digitek may be liable for your suffering.
Digitalis Toxicity
Poisoning from Digitek and related drugs is called digitalis toxicity due to the fact that these drugs derive from the digitalis plant. Digitalis toxicity can be caused by intolerance to the drug or by an excessive dose (acute ingestion). Patients taking Digitek prior to the recall may have experienced digitalis toxicity after ingesting defective pills that were manufactured at twice the approved thickness.
Digitalis toxicity can have serious side effects, including arrythmias, bradycardia (slow heartbeat) and low blood pressure, as well as more minor effects such as nausea, vomiting and dizziness. In patients with heart problems, the condition may be intensified by the diuretics that are often prescribed, which can deplete the body of potassium. Potassium plays a vital role in the function of muscles, including the heart.
Symptoms of digitalis toxicity include the following:
- Irregular pulse
- Nausea
- Vomiting
- Diarrhea
- Loss of appetite
- Palpitations
- Confusion
- Visual changes
If you or someone you know was taking Digitek and experienced any of the symptoms or Digitek side effects outlined above, contact an attorney specializing in defective drug cases immediately.
The Digitek Recall
In April of 2008, Actavis pulled Digitek from the shelves through a Class I recall. (Class I recalls are initiated when a drug poses a very serious risk of health problems or death.) Recalls also have been issued for generic versions of Digitek. However, the recall does not include the capsule and injectable forms of the drug.
Since the recall, both Actavis and the Food and Drug Administration (FDA) have been widely criticized for their handling of the situation — particularly in regard to the lack of urgency with which the pills were collected and the methods used to track the recalled pills. Critics and plaintiffs claim that Actavis should have acted more swiftly after it received two critical letters from the FDA, which admonished the company for shoddy production practices at its New Jersey plant.
Criticism has not been limited Actavis, however. In January of 2009, The Institute for Safe Medication Practices (ISMP) lambasted the FDA, citing the Digitek recall as a prime example of the FDA's failure to properly collect and test recalled drugs. “Without extensive testing of distributed and recalled tablets,” ISMP noted, “it is difficult to separate cases caused by defective tablets from other causes, including declining kidney function, decreasing cardiac output and failure to monitor blood levels of the medication.”
Digitek Lawsuits
Numerous lawsuits have been filed against Actavis and other manufacturers and distributors of related medications. Some of these suits have accused the companies involved of negligence. Other lawsuits have been filed under pharmaceutical liability and product liability laws. Under these laws, a company is liable for any defects in its products which cause harm, regardless of whether negligence was involved.
If you or someone you know has suffered injuries or harm as a result of taking Digitek or a related drug, contact a personal injury lawyer as soon as possible. Statutes of limitations may limit the amount of time you have to file your claim. Family members of patients who have died as a result of taking Digitek may be able to file suit for negligent death. A lawyer for fatality specializing in defective drug cases can assess your case and help you determine if this applies to your situation. 