Pansy Mae Christian, who suffered from a cardiac condition, died on November 8, 2007 after taking Digitek prescribed by her doctor. On May 2008, Christian’s estate administrator James R. Christian received notice of the drug’s recall and complaints about significant adverse side effects.

On January 15, 2008, Gary Lucineo suffered toxicity and died after taking Digitek prescribed by his physician for congestive heart failure. His estate administrator, Jeanette Lucineo, is suing the companies, claiming they failed to warn users of the drug that the medication was provided for use by the public with twice the approved level of active ingredient. That overdose caused toxicity that the suit claims contributed to Mr. Lucineo’s death.

In April 2005, Actavis Totowa LLC, initiated a nationwide Class I recall of Digitek after it learned that oversized tablets had been distributed, which likely contained twice the level of active ingredient. Taking more than the FDA-approved level of Digitek can lead to Digitek toxicity, also known as digitalis toxicity, a serious and life-threatening complication. Symptoms of digitalis toxicity include unusual visual changes, confusion, loss of appetite, nausea, vomiting or diarrhea, palpitations or irregular pulse.

If you are taking digitalis medications and symptoms of digitalis toxicity develop, contact your healthcare provider immediately.

SOURCE: Digitek Recall › Two lawsuits filed against makers of Digitek heart medication

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

The fact sheets will be used in court to determine whether Mylan Pharmaceuticals of West Virginia, Actavis US and DUL Laboratories misrepresented Digitek as safe and whether physicians and patients relied on those “misrepresentations and deceptions” in choosing to use the heart medicine.

Digitek is used in the treatment of various heart conditions such as atrial fibrillation, atrial flutter and heart failure. In 2008, the FDA issued an alert to the public of a recall of Digitek, after it was found that some tablets had been released at double the thickness, which were thought to contain double the active ingredient. As a result, some patients experienced digoxin toxicity, which can result in life-threatening complications.

The lawsuit argues that, “Plaintiffs have sustained severe physical injuries and/or death, severe emotional distress, mental anguish, economic losses and other damages for which they are entitled to compensatory and equitable damages.”

The fact sheets require plaintiffs to detail 10 years of medical history including the names of every doctor who saw them, every hospital that admitted them and every pharmacy that dispensed medications to them, as well as providing full disclosure for psychological disorders, substances abuse and acquired immune deficiency syndrome. They also are required to list all drugs they have taken and list possible side effects, complete a chart of diagnoses of family members, and state how much they smoke, how long they have smoked, and how much and how often they drink alcohol. They must complete charts of Digitek or Lanoxin pills usage. And, plaintiffs must submit job records including pensions and insurance and disclose all workers compensation claims, disability claims and personal injury lawsuits.

To date, more than 100 Digitek lawsuits have been transferred to U.S. District Judge Joseph Goodwin, and more are expected to be added.

SOURCE: Digitek Recall › Those suing for Digitek injury must fill out lengthy fact sheets

According to the West Virginia Record, the suit claims, “Digitek contains twice the approved level of active ingredient and a narrow therapeutic index, which means the medication has a limited margin between effectiveness and toxicity.”

Digitek has a negative history.  Since 2006, 11 or more complaints have been recorded about the dangerous side effects of the drug, which include injuries and diseases.

At this time, Digitek is the only heart medication that is supposed to correct atrial fibrillation, atrial flutter and heart failure. Instead of correcting these problems, Digitek has unfortunately lead some consumers to their deaths and has also affected numerous loved ones in the process.

Being filled with mental agony and grief are just a few ways John Anthony Conte has suffered in losing his wife to Digitek ingestion. Though John Anthony Conte seeks compensatory and punitive damages for his wife’s estate, his wife cannot be replaced.

SOURCE: Digitek Recall › Kentucky man files digitek suit after losing wife

Journal editor Dr. Jeffrey M. Drazen says the litigation process and the court system is a “key defense mechanism” to insure drug safety and to obtain justice if drug manufacturers have not made the risks involved with its product clear.

The doctors say the FDA is incapable of being the sole guardian of drug safety and that without the information supplied by liability litigation, “the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”

The opinion was submitted to the Supreme Court as a friend-of-the-court brief in the matter of Wyeth v. Levine, a case expected to be heard later this year. According to the AP story, the case involves Diana Levine, a guitarist who lost her right arm below the elbow after an injection of Phenergan. She sued the drug’s manufacturer, Wyeth, alleging the company had not adequately warned consumers of the risks associated with its product. The case was tried in Vermont, and the court agreed, awarding Levine $7 million.

Wyeth is appealing the case, saying the FDA had approved the drug, and that the state court could not overrule the FDA’s judgment.

However, the editors of the New England Journal of Medicine sided with 47 state attorneys general and two former FDA commissioners in supporting Levine’s position, the AP report states.

SOURCE: Digitek Recall › doctors support drug safety litigation

Doctors prescribe the drug, Digitek, to treat heart failure and abnormal heart rhythms.

Actavis Totowa, a Totowa, N.J., manufacturer, recalled Digitek after consulting with the Food and Drug Administration. Actavis makes Digitek for Mylan Pharmaceuticals of Pittsburg, Pa.

Actavis counsel John LaRocca said the company recalled Digitek after at least one pill emerged from the manufacturing process at double the appropriate thickness. An FDA statement said: “These tablets may contain twice the approved level of active ingredient than is appropriate.”

Double-strength tablets could lead to toxic levels of digitalis in patients with renal failure.

“We had some concerns about the process,” LaRocca said. He said the company knew of no deaths linked to Digitek use but Actavis and the FDA had received 11 complaints about side effects since 2006.

Actavis has asked pharmacists to instruct consumers to return all unused Digitek pills and to consult their physicians. While recalls often result in the removal of drugs from pharmacy shelves, consumers seldom receive personal notification.

At North Shore Pharmacy in Huntington, supervising pharmacist Ron Wood said, “We never keep the generic [Digitek] in stock, so it [the recall] doesn’t apply.”

Joel Bassuk, pharmacist at Raindew Pharmacy in Manhasset, said he received the recall notice yesterday but he only has about five customers who use the drug.

“They said to immediately examine your inventory and discontinue all lots,” Bassuk said, noting he has had no reports of adverse side effects.

CVS spokesman Mike DeAngelis said the chain had removed all Digitek from its stores. “We went back to see which patients had prescriptions over the past 12 months and contacted them,” DeAngelis said.

SOURCE: Newsday

SOURCE: Digitek Recall › Pharmacists will call: Digitek recalled