Digitek recall issued after patients suffer digitalis toxicity due to improper manufacturing
Drugmaker Actavis Totowa issued a Digitek recall on April 25, 2008 after a number of patients experienced overdoses while taking the drug. The company says that some tablets of the heart medication were improperly manufactured at twice their normal thickness. As a result, patients could be getting a double dose of its active ingredient, digitalis, which could increase their risk of an overdose due to digitalis toxicity.
Digitek, which is also known as digoxin, is designed to treat certain heart conditions, such as an irregular heart beat or congestive heart failure. The drug works by increasing the amount of calcium in the heart muscles, which helps to stimulate and strengthen the beating of the heart. Digitek also works to slow the heartbeat and to eliminate the accumulation of fluid from the body.
Receiving an increased dose of digitalis could lead to a number of serious and potentially deadly Digitek side effects. Patients who receive an increased dose of Digitek could experience problems breathing, diarrhea, nausea, vomiting, heart palpitations, an irregular pulse or changes in vision, such as blurred vision or seeing halos or bright spots.
In more serious cases of a Digitek overdose, digitalis toxicity can lead to a heart attack, stroke or even death. Several patients have already reported suffering serious Digitek side effects such as these as a result of taking the drug. Patients with renal failure or other kidney problems may be at an increased risk because they may have difficulty eliminating the drug from their bodies.
The tablets which were involved in the Digitek recall were manufactured by Actavis and distributed by either Mylan Pharmaceuticals or UDL Laboratories. Tablets that were distributed by Mylan were sold with the label “Bertek,” while those that were distributed by UDL were sold under the “UDL” label.
Some experts have criticized Actavis’ response after issuing the Digitek recall. Although the company issued a press release in April to announce that it was issuing a digoxin recall, some have accused the company of not doing enough to alert doctors and patients of the extent of the problems with Digitek, including how long the improperly manufactured tablets were on the market before the Digitek recall order was made.
However, this latest issue is not the first manufacturing problem that has occurred with Actavis. The Food and Drug Administration sent a warning letter to the company last year which stated that some drugs manufactured its plant in New Jersey were “adulterated.” An Actavis spokesperson has stated that the FDA warning letter was unrelated to the current Digitek recall.
Several patients who were injured after suffering a digitalis overdose have already filed Digitek lawsuits against Actavis. These lawsuits have alleged that the Digitek they were prescribed is a dangerous and defective product. Digitek lawyers have said that they are evaluating cases from hundreds of potential clients to see if they are eligible to file a Digitek lawsuit.
Recently in New Jersey, nine federal lawsuits were filed by patients who were injured after suffering serious Digitek side effects. Similar Digitek lawsuits have also been filed in West Virginia, California and Alabama.
