Digitek, a brand of digoxin, is a widely used treatment for various heart conditions such as atrial fibrillation, atrial flutter and heart failure.

According to the complaint, the companies received a warning from the Food and Drug Administration (FDA) that they failed to provide periodic safety reports for the facility where the medication was manufactured. By failing to provide the safety reports, the companies violated their adverse medical event reporting obligations. The FDA also warned that the drugs were being marketed without proper clearance and that at least 26 adverse events with the drug had not been reported.

In 2008, the FDA issued an alert to the public of a recall of Digitek, after it was found that some tablets had been distributed at double the thickness. Those oversized pills were thought to contain double the active ingredient. As a result, some patients experienced digoxin toxicity, which can result in life-threatening complications.

The complaint states, “The recalled Digitek was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended use.” Plaintiffs also contend that Actavis and Mylan Pharmaceuticals “placed tens of thousands of patients, including Decedent, unnecessarily at risk of serious injury and/or death and may have caused them to suffer personal injuries and harm, including medical expenses, anxiety and fear induced from ingesting the defective and misbranded drug.” The plaintiffs are asking for a trial by jury.

Source: The Southeast Texas Record

SOURCE: Digitek Recall › Product liability lawsuit filed against Digitek manufacturer, distributor

Watson Pharmaceuticals, Inc., announced the voluntary recall of Propafenone HCL 225 mg tablets sold in 100-count bottles in the United States. The affected tablets were sold to customers between October 15, 2008 and November 26, 2008. No other strengths or lots were affected and the company does not anticipate any product shortages as a result of this recall.

Propafenone is a drug product used to treat cardiac arrhythmias, or irregular heartbeats. It has a narrow therapeutic index, so some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure.

Watson is recalling the lot at the consumer level as a precautionary measure to minimize any potential risk to patients. Patients using 225 mg Propafenone HCL tablets who have medical questions should contact their health-care provider.

Last spring, generic drug maker Actavis Totowa LLC issued a Class 1 recall of its digoxin heart medication Digitek. A Class 1 recall is the most serious type of recall and involves situations in which there is a reasonable probability that use of the product will cause serious injury or death. The recall came after the company discovered oversized tablets containing twice the level of active ingredient.

Source:
FDA

SOURCE: Digitek Recall › FDA recalls another heart medication for oversized pills

Digitek was cited by the Center for Public Integrity as the “primary suspect” in 667 deaths reported between April 1, 2008 and June 30, 2008. Digitek is prescribed for various heart conditions such as atrial fibrillation, atrial flutter and sometimes heart failure. An incorrect dosage or overdosage can be dangerous and even fatal to heart patients taking the medication, causing even more cardiac instability and compounding existing problems.

Last April, it was discovered that some tablets produced in the Actavis New Jersey plant were oversized and contained as much as twice than the marked dosage of the active ingredient. A massive recall was ordered and Actavis contends that none of the oversized pills reached consumers. The New Jersey plant was officially closed in August to correct its shoddy manufacturing practices, and in November the U.S. Justice Department ordered the plan remain closed until it could prove it has met the FDA’s “Good Manufacturing Practice.”

In January, the FDA announced that it would allow Actavis to resume its production of Digitek provided it proves it has cleaned up its act. Actavis signed the proposed consent decree but whether it will start making Digitek again is anyone’s guess.

A division of the Icelandic Actavis Group, Actavis is among of the world’s five largest drug makers.

SOURCE: Digitek Recall › Actavis signs consent decree to resume making Digitek

Digitek is a medication widely used to treat heart conditions that cannot be controlled by other medications. Incorrect dosing of the medication can be dangerous, and sometimes fatal. In April 2008, Digitek’s manufacturers issued a nationwide recall because the pills contained twice the amount of the active ingredient. The oversized pills posed a serious risk of digoxin toxicity especially in patients with renal failure.

On behalf of her husband, Rosina Michna has filed a lawsuit alleging medical negligence against the doctor who initially prescribed Digitek but didn’t monitor his blood levels. She also is suing the numerous pharmaceutical companies involved in the manufacture, marketing and distributing of Digitek for negligence, according to the Marin Independent Journal.

An initial hearing of the lawsuit is set for April 27, 2009.

SOURCE: Digitek Recall › Widow files suit against doctor, pharmaceutical companies