Digitek
Manufacturer recalls Digitek due to risk of toxicity
Keywords: Digitek | Recall | Attorney | Santa Rosa | Lawyer | Lawsuit | Side Effects | Digitalis | Toxicity | Kidney / Renal Failure
On April 25, 2008, the pharmaceutical company Actavis Totowa initiated a Class I nationwide recall of its drug Digitek. A Class I recall is the most serious recall category used by the U.S. Food and Drug Administration (FDA). According to the FDA, Class I recalls are for "dangerous or defective products that predictably could cause serious health problems or death."
Digitek was administered orally to treat heart failure and abnormal heart rhythms. The drug was recalled because tablets with double the appropriate thickness were released and sold to the public. Such tablets exposed patients to twice the approved level of the drug's active ingredient. These defective "double strength" Digitek tablets can cause digitalis toxicity in patients with renal failure. Actavis recalled the drug after numerous reports of toxicity surfaced.
Digitek is the brand name for generic digoxin tablets. Digoxin contains the chemical digitalis, which is derived from the foxglove plant. Digitalis increases the amount of calcium in the heart's cells and strengthens the force of the heartbeat. The chemical also slows the signals traveling through the atrioventricular node, which controls irregular heart rhythms.
Toxicity from the chemical digitalis can be caused by high levels of digitalis in the body or a decreased tolerance to the drug. Patients with reduced kidney function are susceptible to an accumulation of digitalis in the body that would normally be excreted through urine. Symptoms of digitalis toxicity may include the following:
- Dizziness
- Nausea and vomiting
- Unusual vision changes (such as halos, light rings, blurriness, blind spots, and changes in color perception)
- Decreased urine output
- Excessive nighttime urination
- Overall swelling
- Difficulty breathing
- Affected heart rate
- Death
Toxicity can occur after acute ingestion (i.e., from a single exposure) or from prolonged digitalis therapy.
Several companies sell digoxin generically for use in brand name heart medicines. Digitek was manufactured by Actavis and distributed by Mylan Pharmaceuticals. Mylan distributed Digitek under the Bertek and UDL labels. Actavis recalled all Digitek tablets distributed under both labels.
Additional Information on Digitek
FDA Recall -- Press Release
FDA MedWatch
Actavis FAQ
FDA Actavis Recall List
Lawsuit
Our firm is currently evaluating claims against the manufacturer of Digitek. If you have suffered digitalis toxicity after taking Digitek, you may have valuable legal rights. For a free and confidential consultation, please fill out the form to the right or contact attorney Tarik J. Naber at (707) 545-1660 or tnaber@gsoglaw.com.
