Consumers who take the medication Digitek (digoxin) for heart problems should be aware of a serious and potentially fatal manufacturing defect associated with the drug.
Digitek, which is manufactured by Actavis, is most often prescribed to patients suffering from heart failure or those who need their heartbeat regulated due to atrial fibrillation. It is also prescribed to heart attack survivors as a preventative measure against future attacks.
To date, thousands of patients have suffered serious Digitek side effects, potentially without even knowing the drug was responsible for their symptoms. Several patients have also lost their lives while taking Digitek, leading many to speculate the drug was directly related to the patients’ passing.
If you or a loved one has taken Digitek and has suffered adverse consequences, contact the class action attorneys at Gordon & Doner today. We have the knowledge and resources necessary to file a Digitek class action lawsuit on your behalf and help you receive the justice and compensation you deserve.
Digitek Side Effects
Actavis recalled Digitek in April 2008 after discovering the drug was manufactured with double the normal thickness and twice the approved level of its active ingredient.
According to the Food and Drug Administration (FDA), the double strength tablets can cause an illness known as Digitalis Toxicity. This occurs when excessive amounts of the drug’s active ingredient accumulate in a person’s body.
Symptoms of Digitalis Toxicity include:
- Unusual vision changes, including seeing everything through a “yellow haze”
- Difficulty breathing
- Muscle weakness
- Fluid retention
- Nausea and vomiting
- Heart attack
- Dangerously low blood pressure or heart beat
Digitalis Toxicity has the potential to be fatal to all victims. However, those suffering from impaired kidney function are particularly at risk, as they are less likely to be able to filter dangerously high levels of Digitek from the bloodstream.
For more information, or to discuss joining a Digitek class action lawsuit, contact us today.
Digitek Manufacturer Offers Little Explanation
It is unclear how an FDA-regulated medication was manufactured with twice the recommended amount of its active ingredient, or how the noticeably enlarged tablets passed quality control inspections, time and time again.
The fact that doubly thick, doubly potent Digitek tablets were manufactured and distributed suggests that, at some time during the manufacturing process, two single tablets were combined into one. This explanation would account for the increased size and strength of the tablets, However, FDA regulators are still uncertain as to how so many significantly larger tablets made it past Actavis’ quality control unit.
To date, Actavis has offered no explanation as to what happened, what may have happened, or what is genuinely thought to have happened during the manufacturing process.
Actavis has only stated there was a “manufacturing problem” at the time the faulty Digitek tablets were produced. The company has not offered any additional details that may help clarify its somewhat vague admittance of a “problem.”
The Digitek class action lawsuit attorneys at Gordon & Donner believe those suffering from Digitek side effects deserve a much better explanation. They also deserve justice and compensation for their pain, suffering, medical bills, and diminished quality of life.
If you are, or think you may be, suffering from Digitek side effects, contact our Digitek class action lawsuit attorneys today. We can help.
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What is Currently Known About the Digitek Recall
According to an article published last year in the Validation Times newsletter, the FDA had already been concerned with quality control problems at Actavis prior to the defective Digitek tablets being recalled.
Allegedly, several FDA inspections were conducted at the Actavis manufacturing plant in Little Falls, New Jersey, where the double-sized, double potent tablets were made. The inspections were conducted from July through August, 2006, and resulted in some alarming FDA-issued citations.
Among Actavis’ list of citations was a number of “significant deviations from good manufacturing practices” for improperly producing several drugs at the facility. These deviations included numerous failures on behalf of the quality control unit to adequately investigate and resolve laboratory discrepancies, such as test results that indicated a drug did not meet the required specifications for sale or use.
FDA inspectors also reported observing deviations in the manufacturing process of medications. According to inspectors, there was no indication of prompt action by Actavis to respond to either the handling of laboratory discrepancies or deviations in the drug manufacturing process.
In 2006, Actavis sent a letter to the FDA addressing its concerns and ensuring that corrective measures would be taken. However, more than two years passed before Actavis issued a recall on its dangerous Digitek tablets. During that two-year time period, countless patients suffered severe Digitek side effects, some of which may have been serious enough to end patients’ lives.
If you have legal questions regarding an injury or death related to Digitek, contact the Digitek class action lawsuit attorneys at Gordon & Doner today. Our personal injury lawyers believe that all manufacturers of defective and dangerous drugs should be held accountable for their negligent and unethical actions. We also believe that all victims deserve justice and the maximum amount of financial compensation allowed by law.
Contact us today; our Digitek class action lawsuit attorneys are ready to put their knowledge and experience to work for you. If you or someone you love is suffering from Digitek side effects, we have the answers and legal help you are looking for.