Urgent Digitek Recall: Defective Pills Could Cause Fatal Overdose
On April 25, 2008, a nationwide recall was issued for all strengths of Digitek, a prescription drug used to treat heart failure and abnormal heart rhythms. According to Actavis Totowa LLC, Digitek’s maker, a manufacturing defect may have caused double-strength Digitek tablets to be released to the public. The Digitek recall related to tablets that are distributed by Mylan Pharmaceuticals Inc. under a “Bertek”? label and by UDL Laboratories, Inc. under a “UDL”? label.
Although very little information is available about the scope of the Digitek problems, the Digitek recall is classified as a class I recall, meaning that the defective Digitek tables could cause serious health problems or death. All together, it is estimated that up to 50 percent of the Digitek currently on the market could contain a dangerous double-dose.
Because the active ingredient in Digitek is poisonous if taken in excess, the recalled double-strength Digitek pills may be extremely dangerous. In fact, recall information posted on the FDA website states that double-strength Digitek pills pose a risk of digitalis toxicity, a potentially fatal condition caused by Digitek overdose. Early symptoms of digitalis toxicity may include nausea, vomiting, diarrhea, abdominal pain, hallucinations, delirium, cardiac instability, low blood pressure, and severe headache
Following the recent Digitek recall, a Digitek lawsuit seeking class action status was filed in U.S. District Court in New Jersey against Digitek’s foreign maker, Actavis Totowa LLC. One of the lead plaintiffs in that class action is a woman who alleges she experienced changed cardiac symptom episodes, nausea, and dizziness from taking Digitek. In addition, another plaintiff alleges he may have suffered serious personal injuries, including kidney damage, after taking the defective drug.
According to the Digitek lawsuit, the FDA issued a warning letter to Actavis back in August 2006 for failing to provide periodic safety reports at its oral dose manufacturing plant in Little Falls, N.J. The lawsuit alleges that some of the defective double-strength Digitek was manufactured at that plant. In addition, the suit claims that an FDA inspection in early 2006 revealed six potentially serious and unexpected adverse drug events dating back to 1999 for products that included generic Digitek, that Actavis did not report to the agency.
Should the plaintiffs in the Digitek lawsuit prevail, they may be entitled to compensation for their injuries, as well as money to cover medical monitoring in case they experience future health problems. In addition, the class action plaintiffs could recover monetary damages for pain and suffering and lost income.
If you or a loved one has suffered an injury that you suspect is associated with Digitek or any other medication, our Digitek injury lawyers can confidentially inform you of your legal rights and options at no cost or obligation to you. Contact Us Today.