What is Digitek?
Digoxin is a medication used to treat congestive heart failure, abnormal heart rhythms and other heart conditions. It has been marketed under the brand name Digitek. The recalled products were distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label.
What are the dangers associated with Digitek?
On April 25, 2008, drug manufacturer Actavis Totowa LLC issued a Class I recall of Digitek (digoxin) tablets. Digitek was recalled due to the possibility that tablets were doubled in thickness and could contain twice the appropriate level of the active ingredient.
The existence of double-strength pills pose a risk of digitalis toxicity, which can result in nausea, vomiting, low blood pressure, cardiac instability, bradycardia and even death.
Digitek is a registered trademark of Actavis Totowa (formerly Amide Pharmaceutical, Inc.) for their digoxin tablets, which are prescribed to treat heart failure and abnormal heart rhythms. The drug is distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label.
Patients taking Digitek should contact their physician immediately for medical advice. Retailers who carry Digitek should return the product to the place of purchase. Overdosing on this drug can be very dangerous.
Digitek Side Effects
An individual who has taken the recalled Digitek may experience the following side effects:
- bradycardia (abnormally slow heart beat)
- cardiac instability
- low blood pressure (hypotension)
These are the Digitek side effects described in the voluntary recall announcement by Digitek’s manufacturer, Actavis Totowa LLC. The U.S.Food and Drug Administration (FDA) also listed these side effects as the reason for its April 2008 Safety Alert regarding Digitek.
Digitek has other, more common side effects that may appear even with a dosage that is not mistakenly doubled (as in the recalled Digitek). These side effects include:
- abdominal pain
- adverse cardiac effects
- confusion and mental disturbances (e.g., hallucinations, anxiety, delirium, and depression)
- gynecomastia (enlargement of male breasts)
- hemorrhagic necrosis of the intestines
- intestinal ischemia
- maculopapular rash (a flat, red areas on the skin covered with small bumps, as in measles)
- nausea and vomiting
- thrombocytopenia (low platelet count in the blood, making an increased risk of bleeding)
- visual disturbances (blurred or yellow vision; the appearance of blurred outlines/halos)
Digitalis toxicity can occur from a single exposure or chronic overmedication, or it may occur in patients with normal blood levels of digitalis if other risks are present.
Risks include taking digitalis medications such as Digitek (digoxin) or digitoxin, along with medications that interact with digitalis such as quinidine, verapamil, amiodarone, and others.
People with heart failure are commonly given diuretics (medications used to pull excess fluid from the body) along with digoxin. Many diuretics can cause potassium loss. Low levels of potassium in the body increase the risk of digitalis toxicity. Digitalis toxicity may also result from low levels of magnesium in the body.
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.
Why is Actavis recalling Digitek (digoxin)?
This voluntary all-lot recall is due to the possibility that some tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than is appropriate.
What should I do if I’m taking Digitek (digoxin)?
Patients should contact their physician to get a new prescription. All inquiries related to returning your product or the recall should be addressed to Stericycle customer service.
What should I do if I was seriously injured as a result of Digitek?
You should contact an attorney to review your legal options as soon as possible. While product liability laws vary by state, you have a very limited time in which to file a claim against the manufacturer. If you have legal questions, you may contact Beasley Allen for a free legal consultation.
How can I report serious side effects from, or reactions to, Digitek (digoxin)?
If you wish to report an adverse experience from taking digoxin, you are directed to select option “3” from the menu provided on the Stericycle answering service where you will be directed to an Actavis representative who will process your information.
You may also report adverse side effects via the FDA’s online reporting form.
If you need medical attention or have any inquiries regarding your treatment, however, you should contact your physician.
What is Digitek (digoxin)?
Digitek is the brand name for digoxin tablets, USP 0.125 mg and 0.25 mg, manufactured by Actavis and distributed by Mylan Pharmaceuticals, Inc. under the Bertek and UDL labels. It is prescribed for oral use to treat heart failure and abnormal heart rhythms.
Where is Digitek (digoxin) manufactured?
Digitek is manufactured in the United States by Actavis Totowa, in New Jersey.
Is the recall just in the United States, or also in other countries?
The recall is only in the United States.
What can I do?
If you or a loved one has suffered a serious side effect as the result of taking Digitek, you may be entitled to compensation. For a free legal consultation, contact us today!