Digitek Problems Linked to 667 Deaths
Published: December 29th, 2008 • Comments: 8
Following Actavis Totowa’s Digitek recall in April 2008, the FDA received a spike in adverse event reports involving the generic digoxin heart drug and it has been identified as the “primary suspect” in at least 667 deaths reported to the agency from April 1 through June 30, 2008.
Digitek (digoxin), which was manufactured by Actavis Totowa, is used to treat heart failure and irregular heart rhythms. A recall for all lots of the drug was issued on April 25, 2008, after it was discovered that some tablets may be twice as thick as they are supposed to be, containing up to double the appropriate amount of the active pharmaceutical ingredient.
Oversized Digitek tablets could increase the risk of a digoxin overdose, know as digitalis toxicity, which can cause serious and potentially fatal injuries, including arrhythmias, heart failure and death
The Center for Public Justice, which is a nonprofit organization that produces original investigative journalism on issues of public concern, released a report on December 22, 2008, which questions whether the FDA and drug maker missed critical signals of Digitek problems and whether additional steps should have been taken to protect the public.
An analysis of FDA records indicates that there was a spike in reports Digitek problems during the months around the recall.
The Center’s report criticizes the FDA for taking too long to act on manufacturing problems at the New Jersey plant where Digitek was made, as FDA inspections up to two years prior to the recall uncovered signs of poor manufacturing practices and quality control problems. In addition, a number of public health experts indicate that the spike in reports of Digitek problems should have caused the FDA to more aggressively warn doctors, pharmacists and consumers about the risk of potentially defective tablets.
Despite the spike in Digitek problem reports, Actavis has maintained that none of their double strength pills ever reached the public, and that the recall was only issued as a precaution.
The company faces potentially hundreds of Digitek lawsuits filed on behalf of users who allege that serious and fatal digoxin overdose injuries were caused by oversized tablets they received. As of early November, at least 66 lawsuits over Digitek problems filed in federal courts have been centralized in an MDL in the U.S. District Court for the Southern District of West Virginia, and additional lawsuits have been in various state courts throughout the United States.
Comment by Jennifer on 30 December 2008:
My father passed away this past April after taking Digitek. I have an attorney and I assume it will be going to court soon. But none of that matters. No amount of money will bring my Dad back or take away any of the pain that he suffered before he passed or any of the pain that I suffer now. I recently read that 667 people may have died because of this drug. That is 667 too many. 667 Grandparents, Moms, Dads, Husbands, Wives, Sons, Daughters, Brothers, Sisters, Aunts, Uncles, Cousins and Friends. Not to mention the countless others that are living with other complications because of this medication. When are these drug companies going to stand up and take responsibility. I can’t remember the last time that I went to any Doctor without a drug rep waiting in the waiting room or catering lunch for the Doctor and his staff. One of my Doctors was even sent on vacation by one of these drug companies. Should that even be legal?
Pingback by Watson Propafenone HCL Recall Due to Oversized Tablets - AboutLawsuits.com on 25 March 2009:
[...] may have been commercially released that contained up to twice the appropriate amount of the drug. Oversized Digitek tablets have been linked to 667 deaths between April 2008 and June 2008, and a growing number of Digitek [...]
Pingback by Generic Digoxin Recall Issued Due to Oversized Tablets - AboutLawsuits.com on 1 April 2009:
[...] According to a report issued by the Center for Public Integrity in December 2008, at least 667 digoxin deaths were reported to the FDA between April 2007 and June 2007 involving potentially double strength [...]
Pingback by Digoxin Recall Causes Other Generic Drug Makers to Step Up Supply - AboutLawsuits.com on 3 April 2009:
[...] 667 deaths have been reportedly linked to a Digitek overdose, highlighting the dangers associated with production problems involving [...]
Comment by kim on 17 April 2009:
My father was a strong man that drove himself to the hospital for his heart surgery. He recovered did his rehabilitation but could never quite snap out of it. He received the digitek in april approximately 8 months after his heart surgery. He was a nonsmoker, not over weight and very mobile person. He drowned in his own congestive heart failure. He’s heart could beat hard enough to keep him moving and from getting tired. The heart monitor was very erratic and slow. I was with him when he took his final breath at hospice. He was only 66. He was such a good person. He trusted everyone. even when it came to taking his medicine he thought it was the right thing to do. After he passed away we received the letter that he did get medicine from the lots that were double strength. It hurts so much.
Comment by Niki on 28 May 2009:
My Father was prescribed Dogoxin for his heart condition and didn’t live past his 47th birthday. This is horrible that doctors can prescribe any medication that they may think will work and is safe for everyone to take. My whole family is suffering from their mistake! There is nothing in this world that can bring my father back!
Comment by Liz on 16 September 2009:
My grandfather passed away in January 2009. We received a letter from a pharmacy company in April 2009 that the Digoxin he was taking was being recalled, for the same reason as the Digitek product, varying pill sizes. My grandfather was very healthy and active. He was always on top of his regular physician visits, taking his meds, exercising. When he passed, even his doctor was shocked. We had no reason to believe that it could have been his medication. His death is recorded as heart failure. Because the paramedics declared it as natural causes, there was no autopsy or toxicology report done. Now, there is no way to prove that this could have been the cause of his death. After receiving the letter, I began my research. How could a company manufacturing a classified dangerous drug not implement additional quality control procedures knowing that their competitors had 667 deaths linked to the defective pills. It is criminal. No amount of money is going to bring him back, Mr. Latrosky from Caraco Pharmaceuticals stated that there have been no deaths linked to the drug. I think he is wrong. I think my grandfather would still be alive today if it wasn’t for their gross negligence. I don’t think that my grandfather is the only one that this may have happened to either.
Comment by Tim on 15 October 2009:
Who was responsible for determining who, if anyone, received the incorrectly manufactured products which was presumably determined by matching lot numbers to prescription numbers. Was it the manufacturer?
Was it the pharmacist? Was it the FDA? Was it another entity? Did any and/or all work together in determining who, if any, received the incorrectly manufactured products? Is it fair to assume that some or all of those involved have individuals working for the organization and/or own the organization who might have legal liability as a result of this apparent error? If so, is it fair to assume that some might have a very strong interest in avoiding liability and, if so, is it also fair to assume that some or all of those individuals might not be completely forthcoming in terms of their involvement or that some or all of those individuals might have strong motivations to cover up or misrepresent their involvement.
If I had a family member pass away as a result of a heart problem around this time period and they were using this drug, I think I would pursue legal action even if information was made available that contradicted a finding of error. My assumption would be that almost everyone involved has a strong motivation to lie and believing the fox when he says he didn’t eat the chicken would be irresponsibly naive.