Digitek Digoxin Recall: Tablets May Be Double The Normal Dose

So-called "Digitalis Toxicity" Is Possible, Especially In Patients With Renal Failure

(Posted by Tom Lamb at DrugInjuryWatch.com)

In an April 28, 2008 MedWatch Safety Alert about Digitek (digoxin tablets), the FDA informed doctors and patients that this prescription medication is the subject of a nationwide Class I recall because of the possibility that some tablets were manufactured such that they contain twice the approved level of active ingredient.

In more detail, according to this Digitek MedWatch Safety Alert:

  • The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label.
  • The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure.
  • Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia.

This April 28 MedWatch Safety Alert came several days after a press release about this Digitek manufacturing problem was issued by Actavis Totowa LLC (formerly known as Amide Pharmaceutical Inc).  Therein, the manufacturer said it is recalling all strengths of Digitek because it may have accidentally released pills that are double the normal thickness, carrying twice the normal dose.

Digoxin is used in the treatment of arrhythmias and heart failure.

Patients taking Digitek tablets should contact their doctor if they have any concerns or questions.

P.S.  According to a brief newspaper article dated April 25, 2008, "Digitek heart drug recall":

[Actavis Totowa LLC spokesman] John LaRocca said 11 people have reported getting sick after taking the drug, but the Morristown, N.J., company is not aware of any deaths.

We will keep you informed about the number of patients injured by Digitek (digoxin) tablets that were defective, i.e., manufactured with a double-dose, as well as anything that we learn about the dates when these recalled Digitek tablets were being dispensed at pharmacies across the country. 

My law firm has been contacted already by several people who have had family members hospitalized with serious side effects apparently caused by the defective Digitek tablets.  We are in the process of investigating possible Digitek cases where the patient was hospitalized or that involve a death that may be related to the person’s use of Digitek tablets.  (5/1/08)

41 responses to “Digitek Digoxin Recall: Tablets May Be Double The Normal Dose”

  1. Jacleen Avatar

    Mom’s in ICU because of this error.

  2. Tom Lamb Avatar

    I hope your mother recovers well from this unfortunate adverse drug event.
    What seems peculiar at this juncture is the seeming lack of information about the dates when this manufacturing mistake took place and the number of tablets that are “suspect” as regards the potential double dose, or overdose, of this medication.
    Perhaps the drug company or the FDA will be more forthcoming in the near future.
    Tom Lamb

  3. Gail Potts Avatar
    Gail Potts

    Feb 22 my mother developed nausea and itching , low blood pressure after taking her to Walkin clinic they sent us to ER. She was then told her kidney were in stress. They admitted her, ( SHe has CHF and afib
    she had been in hospital in Jan for swelling due to Chf. After a week they moved her to Nursing home for Pt, they said, now I wonder. She swelled up again and after going back to ER, they said her spleen was full of blood and moved to ICU acted like they would do surgery. Next day she was back in a progressive room they called it, and was out of her mind, We asked if she has pnemonia, they said no, She has blood infection and all they could do was give medicines, She died that nite.
    They put Pnemonia and CHF on death certicate. She was 83, and was taking this recalled medicine. How can I find out if she was overdosed on this medicine and it started her downslide.

  4. Tom Lamb Avatar

    I am sorry for your loss.
    At this time there remains quite a bit to learn about the Digitek defective pill situation, as I pointed out in my follow-up article dated May 2, 2008:
    http://www.drug-injury.com/druginjurycom/2008/05/fda-says-it-doe.html
    I would suggest you contact the pharmacy where your mother obtained her Digitek to see if they have been notified what lots of the Digitek may have been part of this “double-dose” problem.
    I would be interested to hear about what you find out if you contact the pharmacy.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

  5. Lorrie Avatar
    Lorrie

    I am a cardiomyopathy patient who has been taking 5 heart drugs ince 1984. This is the first time that I have had a frantic call from my pharmacy (Costco in Wharton, NJ) telling me to not take another Digitak pill and to bring the bottle and remaining pills back to the pharmacy. They told me that the pills were a much higher dose than what the bottle says. They are going to replace the pills with a branded Digoxin. I have been feeling very tired lately and my heart has been beating too hard. I couldn’t understand why I was feeling this way. Now I know!!!!!!!! Are the pharmacys taking the bottle and remaining pills back to protect themselves? What happens if I have a long term effect from this high does of Digitak? How could I prove that I had it if they take the proof??? What is the Govt doing about this fiasco?

  6. Tom Lamb Avatar

    For all kinds of reasons, I would hold on to the bottle and your remaining Digitek pills until this manufacturing defect situation gets more defined. There is no reason, in your best interest, that the drug company nor the pharmacy needs the pills or the the bottle — and you can imagine why the drug company, at least, would like to collect the “evidence”.
    My advice to you and other people who have used the Digitek tablets that may have had a “double dose” is to hold on to their bottle(s) and pills until more is known about how long there has been an manufacturing defect problem at the Actavis plant in NJ as regards these generic Mylan-Bertek and UDL digoxin tablets.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

  7. Gail Potts Avatar
    Gail Potts

    Feb 22 my mother developed nausea and itching , low blood pressure low pulse, dizziness, after taking her to Walkin clinic they sent us to ER. She was then told her kidney were in stress. They admitted her, ( SHe has CHF and afib
    she had been in hospital in Jan for swelling due to Chf. After a week they moved her to Nursing home for Pt, they said, now I wonder. She swelled up again and after going back to ER, they said her spleen was full of blood and moved to ICU acted like they would do surgery. Next day she was back in a progressive room they called it, and was out of her mind, We asked if she has pneumonia, they said no, She has blood infection and her colon stopped working, and all they could do was give medicines, She died that nite.
    They put Pneumonia and CHF Copd on death certicate. She was 83, and was taking this recalled medicine. How can I find out if she was overdosed on this medicine and it started her downslide.
    UPdate: I talked with the phamacy
    they said she was on 0.125 mg once a day, of the recalled drug She got her refill on Jan 25th, ( she was in hospital in January also,so who knows if she got bad drug from pharmacy or hospital. She died March 16, and my sister who she lived with threw out all her medicines. Will there ever be away to know for my peace of mind.

  8. jen Avatar
    jen

    My dad has been on digitex for over 12 months. They adjusted the dose in Feb. he was having problems with arrythmias, low bp,nausea, fluid on legs etc. He was hospitalized on March 26. My father was having cardiac events on the monitor while in patient. I was told that it was just artifacts on the monitor not to worry. He had a massive heart attack on April 1 and died.
    The last week of April his local pharmacy called to tell us aboutthe recall and wanted us to bring his medication in to the pharmacy. I am really upset I told my mom to hold onto the medication and I am filing a complaint with FDA. Unfortunately on his death certificate it doesn’t state he died from heart attack becasue he also had cll. it says that he died from cll. Being a nurse I know bettter. I am not sure what to do.

  9. Tom Lamb Avatar

    To Gail and Jen:
    Our condolences to each of you concerning the recent death of your respective parent.
    To Gail: As for your situation, with the Digitek pills no longer being available: At present, little is known about how long the Digitek pills were being manufactred improperly. Once more is known, both the outside pharmacy and the hospital pharmacy should be able to determine whether they dispensed the defective, double-dose pills to your mother in the period of time when she was having the medical problems you described.
    To Jen: Holding onto the Digitek pills at this juncture is the best thing to do since you suspect that the pills may have been involved in your father’s death. As far as reporting his death to the FDA, in case you need it, here is a link to our web page that has some information about how to submit an FDA MedWatch report:
    http://www.druginjurylaw.com/medwatch-report.html
    To each of you: My law firm would be interested in investigating the death of your parent. If you want to pursue a possible wrongful death case, please complete the free online Digitek Case Evaluation Form which we have on our Drug Injury Law web site:
    http://www.druginjurylaw.com/DigitekEvaluation.html
    In alternative, you can contact me by email at druginjury@gmail.com
    I hope to hear from you.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

  10. Mary Avatar
    Mary

    My father passed away unexpectedly on 4/12/08. He was taking this medication and has for years. My mother advised he had complained of dizziness, tiredness and visual disturbances and such. He just collapsed for no apparent reason. And now this recall has us concerned. Neither his family doc or his specialist (he was suffering from the effects of a severe case of polio when he was young) can explain why he died so suddenly.
    We’ve been notified of this recall now but it appears it may have been too late. My aunt is a pharmacist and she called my mother immediately regarding this and her opinion is that this may be what killed my father. This is unreal.

  11. Tom Lamb Avatar

    Sorry to hear about the recent loss of your father.
    As I have indicated in my two follow-up articles about this defective / double-dose Digitek recall, there is a remarkable lack of information coming from the drug company and the FDA about the extent of the problem.
    We are currently investigating possible Digitek legal cases where the patient was hospitalized or that involve a death that may be related to the person’s use of Digitek tablets. If you would like us to investigate your father’s death, please contact me when the time is right for you and your family. To get things started, you may want to provide the basic information using our Digitek Case Evaluation Form:
    http://www.druginjurylaw.com/DigitekEvaluation.html
    Of course, you can contact me directly by email or phone if you prefer.
    We hope more will be known about the specifics of this Digitek recall, soon.
    Tom Lamb

  12. Lisa Avatar
    Lisa

    I found out about this recall after refilling the script on April 28th. The pharmacist called me the next day (it was late and night when I ordered refill by phone). I still never heard anything on tv or the news about this recall. I wondered if I hadn’t tried to do a refill would I have been notified. I finally got the call yesterday (over a week after recall notice) and it was a recorded message.

  13. Tom Lamb Avatar

    Thanks for sharing this information about how and when you were contacted by your pharmacy about the Digitek recall.
    It seems to me that we should be getting better information from Actavis or the FDA about how far back in time patients might have been getting the double-dose Digitek pills. Based on what I am hearing about the date-range of patient notifications by various pharmacies, it seems the pharmacies are unsure, also, due to this “silence”.
    We’ll keep you posted on any developments here at Drug Injury Watch.
    Tom Lamb

  14. Mssr. Jouet Avatar
    Mssr. Jouet

    I got home today (5/6) to read the ‘confidential’ letter from Rite-Aid (based in Harrisburg) dated 4/28 and posted in Reading, PA on 5/3. I have dilated cardiomyopathy with aortic stenosis, suffered a heart attack in mid-December after moving to
    Charleston, West Virginia from New England, ‘coded’ during the dobutamine stress test the next day, was shipped cross-town for emergency open heart surgery to replace the aortic valve, suffered a stroke with left-sided hemiplegia during the surgery, and spent five weeks in medical rehab learning to do everything all over again, including walking, and while also fending off atrial fibrillation.
    I am fine now and have suffered no ill effects that I am aware of from the digitalis issue, am unemployed and, with a BA in Communication Studies and three decades of work experience, am available to help out in the public communications departments of either Rite-Aid or Mylan.
    Interestingly, of course, one of the main news stories here is the brouhaha over whether Mylan’s COO, Heather Bresch, daughter of WV Governor Manchin, actually earned her MBA from WVU.
    I can laugh about it because I am still alive, and ambulatory, thanks to the good folks at Thomas Memorial and CAMC.
    Thanks for your service to the folks that need it.
    mssr. jouet

  15. Sandy Avatar
    Sandy

    I am so very angry about all of this!!! I have been so very dizzy and sick to my stomach and have had diarrhea. I’ve been on this medication for many years and had no idea what was going on for the last month or so until I got the call from my pharmacy. I so appreciate the fact that they called me, but my concern now is what are the lasting effects of this overdose?? And, I want to know, if I have been overdosed and quit taking the meds a week ago, how long before the symptoms disappear??? My doctor said they should be gone in a few days, but then again, he didn’t even know about the recall until I told him. Does anyone know how long before the symptoms should disappear? Actually, yesterday I felt pretty good, but today am back to where I was before. I am currently on Lanoxin – not digitek or digoxin. Please, if anyone has any idea when this should go away, please write!!! Thank you!!! I’m really scared.

  16. Light Avatar
    Light

    My grandfather recently died as a result of this medication. He complained of lower back pain, dizziness and falling, as well as vomiting. He eventually fell victim to a pulmonary edema. We will be part of the Class Action Lawsuit being formed now.

  17. Tom Lamb Avatar

    Sandy:
    It would be best to inquire with your doctor about any potential continuing side effects as regards your Digitek use.
    Short of that, perhaps someone who has discussed that issue with their doctor can report what was told to them, generally, about whether there are any “after” effects in this situation.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

  18. Tom Lamb Avatar

    To Light:
    Was your grandfather ever hospitalized because of experiencing one of the serious side effects associated with an overdose of Digitek, namely:
    Low Blood Pressure
    Cardiac Instability
    Bradycardia (slow heart rate)
    Did a doctor ever diagnose “digitalis toxicity”?
    Cases which involve one or more of these medical conditions — and presuming it can be shown that the person had used the defective Digitek tablets — seem to have the best potential in terms of getting some legal compensation from the drug company.
    Further, we believe that such a Digitek drug injury case should be filed as an individual lawsuit, and not made part of a large class action with hundreds or thousands of other people who may have had a lesser adverse reaction to the double-strength Digitek pills.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

  19. Harold Dyer Avatar
    Harold Dyer

    Can digitek help collapse an artery? Please reply Harold E Dyer Sr.

  20. Tom Lamb Avatar

    Harold,
    I do not aware of a collapsed artery being a known side effect of Digitek use.
    It seems this issue is a better question for a doctor.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

  21. Linda Avatar
    Linda

    My mom passed away September 10, 2008. From June 2008 until her death the only complaints were loss of appetite, weightloss,extreme thirst, eventially disorientation and extreme lethargy. Initial set of docs could not diagnose. Second set of docs diagnosed as lung cancer. Mom had no pain, no breathing issues. I felt she starved to death. The day before our first mother’s day without her, we receive a letter from mom’s pharmacy. Their records inidicate she was a recipient of the medication which is now under recall.

  22. Tom Lamb Avatar

    Sorry to hear about the loss of your mother.
    At this time there are many things that remain unknown about the situation concerning these defective Digitek pills that had a double-dose of active ingredient. For some discussion of what is still the “current” situation, you may want to read this page which was posted May 5, 2008 on our Drug Injury Law web site: http://www.druginjurylaw.com/DigitekRecall-interview.html
    Given this situation, at present my law firm is only able to investigate possible Digitek cases where the patient was hospitalized for a serious side effect which may have been caused by the use of Digitek tablets.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

  23. Rhonda Brown Avatar
    Rhonda Brown

    My husband (60 y/o) died Jan. 18. He was dignoised with Dilated Cardio Myopathy and treated with four meds, one of which was Digoxin 0.125 mg tabs / 1X. He died suddenly one morning.

  24. Tom Lamb Avatar

    I am sorry you lost your husband.
    If you are curious about whether any defective Digitek tablets contributed to his death, you should attempt to find out whether there were any abnormal digoxin blood test results, or digitalis toxicity, documented in the medical records for the period of time leading up to his death.
    If there were, then we would have to determine whether, in fact, he had been supplied the double-dose Dititek tablets during that time.
    To the extent you feel there is a possible case to pursue, my law firm is here to help you.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

  25. Michelle Iles Avatar
    Michelle Iles

    My grandfather passed away on March 10, 2008. He was on digoxin for years. Just the past year or so, his health seemed to deteriorate rapidly. He was in and out of the hospital with episodes of heart failure, swelling, dehydration for no apparent reason, problems seeing, sleeping and near the end, difficulty breathing. He was put on oxygen and continued to be in and out of the hospital for those same symptoms over the last few months of his life. Everything I have read about long term overdose of digoxin sounds like a picture of his health before he passed. Kidney failure is what took him in the end, I remember the doctor telling us that his body was just filling up with fluids and toxins and there was nothing they could do.
    Some of the websites I have read suggest that patients who have had too much over a long period of time don’t always show an elevated amount of digoxin in blood tests. Is that true? What else can be used to determine if that is the cause of his death? This whole thing is such a shame. My heart goes out to those who have also suffered or lost loved ones as a result of this.

  26. Tom Lamb Avatar

    I much appreciate you sharing the unfortunate demise of your grandfather and I understand why you are curious as to whether these defective digoxin pills could have been a contributing cause.
    The investigation of these cases has two distinct but related parts:
    (1) So-called “drug supply” — meaning, did the patient get the double-dose Digitek tablets; and,
    (2) Medical causation — that is, is the condition suffered by the patient associated with an overdose of digoxin, or digitalis toxicity?
    We are currently investigating numerous possible Digitek cases involving hospitalization or death.
    Perhaps the most efficient way to give us some basic information about a possible case is to complete and submit our online Digitek Case Evaluation Form:
    http://www.druginjurylaw.com/DigitekEvaluation.html
    Thanks for reading Drug Injury Watch.
    Tom Lamb

  27. Susynn Avatar
    Susynn

    My father 66 passed away last year in April on 09 he was given Digetek on 03/21 and had taken only about 8 pills when he was rushed to the ER and then coded. My mother still has the bottle and the pills and after looking at the pills we have determined that this was a double dose. We have not contacted anyone yet do we have a case?

  28. Tom Lamb Avatar

    Susynn:
    To start, our condolences to you and your family concerning this recent loss of your father.
    I would like to speak with you about this possible Digitek wrongful death case.
    For that purpose, please send me an email — TJL@LambLawOffice.com — providing a phone number and indicate the best times to call you.
    In the alternative, you can call me on our toll-free number, 800-426-9535.
    Of course, you should hold onto the remaining Digitek pills at this juncture, despite the request that have gotten or will get from the dispensing pharmacy that you return the pills to them.
    I look forward to learning more about this situation.
    Tom Lamb

  29. Christina Avatar
    Christina

    In April, 2005 my husband had colon cancer surgery, his bowel was perforated and ended up in ICU for seven weeks with septic shock, was in hospital four months. His kidneys failed and also heart. He has been taking digoxin for three years, if he is not showing any symptoms right now how about down the road, could problems arise later on?
    By the way his kidneys did come back but his GRF is 43 is that low?
    Thank you kindly.

  30. Tom Lamb Avatar

    While I appreciate your concern for your husband’s future health, a medical doctor is better-suited to answer your questions.
    To my knowledge, generally the digitalis toxicity risk goes away once the patient stops taking the Digitek or any other digoxin tablet. If, however, the patient continues taking digoxin other than the defective / recalled Digitek pills, than there remains a risk of developing toxicity, still.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

  31. dianna keeney Avatar
    dianna keeney

    my mother was on both digoxine,and heparin,she was a dialysis patient.we ended up taking her to the hospital for all the symptoms described,she died april 3, a couple weeks later we received a letter from her pharmacy on digitek. would you be able to tell what drug,or if it was caused by either drug?

  32. Tom Lamb Avatar

    I am sorry about the loss of your mother.
    If she was hospitalized before her death, the medical records from that hospital stay may have some test results regarding your mother’s digoxin level — if that specific blood test was ordered by her doctors.
    My law firm would be interested in investigating this possible Digitek death case for you and your family. If interested, please call me on our toll-free number, 800-426-9535, or you can email me: druginjury@gmail.com
    Thanks for reading Drug Injury Watch.
    Tom Lamb

  33. Manny Avatar
    Manny

    What is the appropriate thickness of a Digitek pill?

  34. Tom Lamb Avatar

    Unfortunately I don’t have the correct-sized Digitek pill dimension measurements to provide.
    To see a picture of the two types of Digitek pills, go to our Free Case Evaluation Page:
    http://www.druginjurylaw.com/DigitekEvaluation.html
    Manny, you might want to call Stericycle (1-888-276-6166) — the company hired by Actavis and Mylan to collect all the recalled Digitek pills, which is all pills that were manufactured during the period March 2006 to April 2008 — and ask them this Digitek pill thickness question. If you do, please let us know what they tell you in response.
    If anyone else can help us with Digitek pill thickness information, it would be appreciated by Manny and me, amongst many others.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

  35. Manny Avatar
    Manny

    Thanks, but I’ve already called Stericycle 3 times. A live person never answers the phone, so I always leave a message. They’ve called back just once so far, and all they did was leave a generic message without answering my very clear question about pill thickness. They are not exactly a model for good service (at least not from my perspective). I see that Susynn commented on May 20 that she verified her father’s pills were double thickness/dose – was hoping she’d explain how she did that.

  36. Tom Lamb Avatar

    It’s disappointing that Stericycle is not being more responsive to what seems to be a simple enough inquiry. Perhaps this information is something they would rather not let the public know about….
    Does anyone else have this Digitek pill size / dimensions information to share with Manny and others who are understandably interested in determining whether they unwittingly took one of the defective Digitek pills manufactured by Actavis and distributed by Mylan Pharmaceuticals?
    Manny, maybe your next call should be to the FDA. You can report your experience with Stericycle as concerns this Class I drug recall, and ask the FDA if they will tell you what Stericyle seemingly will not divulge.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

  37. Manny Avatar
    Manny

    Thanks, but I already tried the FDA also. They at least responded after a few days or so, but they sent me to Stericycle for information about the tablets. Same with the pharmacy. All paths lead to the manufacturer, which appears to be trying to avoid liability much more than it is trying to be helpful.

  38. Tom Lamb Avatar

    Manny:
    Thanks for reporting back on your efforts to get information from Actavis, Stericycle, and the FDA about the defective Digitek pills.
    I think you may be right that Actavis is more concerned about its liability exposure than it is with helping alleviate the concerns and fears of patients who might (or might not) have taken the “double-dose” Digitek pills.
    As regards Stericycle, has anyone asked them what they are doing with the Digitek pills that they are getting back from patients, either directly or through pharmacies where patients turned them in as requested? If so, what were you told? Are they keeping track of what pills came from what patients? Are they testing those pills so they know what patients had the defective pills dispensed to them? Or are they simply tossing them in a big hopper so none of that will ever be known? Or, perhaps, destroying them upon receipt?
    To anyone with this type of information, please share it with us by means of submitting a Comment or by sending me an email: druginjury@gmail.com
    Thanks for reading Drug Injury Watch.
    Tom Lamb

  39. johnny graham Avatar
    johnny graham

    does not look like the company is gonna refund the money i paid for the medicine, they give me a different story every time i call.
    has anyone else had this problem?
    they got my medicine back in may.

  40. Tom Lamb Avatar

    Johnny:
    I appreciate you reporting your experience with Stericycle. (I presume you are speaking with Stericycle, as this company was hired by Actavis and/or Mylan to collect the recalled Digitek pills from consumers.)
    Has anyone else spoken with Mylan or Stericycle about the status of any purchase price refund program? If you’ve been paid, perhaps you can let Johnny know how and when, so he can get paid, also.
    Has anyone asked Stericycle what they are doing with the recalled Digitek pills which were sent to them by consumers? Is Stericycle or Mylan keeping the pills with identification information regarding who sent the pills? Is Stericycle or Mylan destroying some or all of the possible defective / “double-dose” Digitek pills?
    Any information you may have about the fate of Digitek pills returned by consumers to Stericycle would be valuable because this issue comes up often when I speak with people who sent in their Digitek pills as requested by Stericycle and Mylan.
    Let us all know what you know, or think, about this aspect of the Digitek recall.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

  41. G. Ann Avatar
    G. Ann

    My MOTHER Died because of this “Accidental Depensed” Overdose Medication …. She started taking this October 2007 and Died Dec 2007 … And She had EVERY SIDE EFFECT LISTED …. INCLUDING DEATH!!

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