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Extent Of Digitek Recall Remains A Mystery Ten Days Later; Patients Are Left In The Dark

Heart Medication Sold By Mylan Was Made In Actavis Plant That Received FDA Letter About Manufacturing Problems Over A Year Ago

(Posted by Tom Lamb at DrugInjuryWatch.com)

News about the April 2008 Digitek recall came first in the form of a brief company press release dated April 25, which was followed by an FDA MedWatch Safety Alert posted April 28 on the agency’s web site.

As of May 5, ten days later, there had been little additional information from Actavis Totowa, the drug manufacturer, and none from the FDA, about the possible extent of the Digitek recall. 

Meanwhile, patients are being contacted by their pharmacists who, admittedly, know nothing more about the situation than what was set forth in the April 25 half-page press release about this "Class 1 nationwide recall of Digitek (digoxin pills, USP, all strengths)".

Understandably, patients are asking how far back in time they have been getting and taking Digitek pills that may have contained double the intended dose of active ingredient.

The latest news about the extent of the Digitek recall comes from a May 6, 2008 article, "Double-strength digoxin recalled in US", by Phil Taylor, which is posted online at In-PharmaTechnologist.com ("Breaking News on Pharmaceutical Technology"), of London, UK.

Because we do not want to misconstrue in any manner the intriguing information developed by Mr. Taylor in his May 6 article, we provide this extended excerpt:

A spokesperson for the company told in-PharmaTechnologist.com that the investigation into the problem was still ongoing, but at the moment there was no further information on what caused it and how many tablets were involved.

This is not the first time that there have been manufacturing problems at the Actavis Totowa facility in New Jersey, which was acquired as part of the takeover of Amide Pharmaceuticals by Actavis in May 2005, although the spokesperson said these earlier issues were entirely unrelated to the current incident.

Just over a year ago Actavis Totowa was sent a warning letter by the FDA after an agency inspection revealed that drugs products manufactured in the facility were ‘adulterated’.

The quality control unit at the site came under criticism from the agency, which said it failed to reliably establish the identity, strength, quality and purity of drug products manufactured and released onto the market. The FDA inspectors also noticed a general lack of investigation of out-of-specification test results, as well as a lack of sufficient documentation of the results.

It is understood, however, that all these ‘Form 483’ issues have since been resolved to the agency’s satisfaction.

Hopefully Actavis and/or the FDA will be making an official announcement, soon, about how far back in time the Digitek pills sold under the "Bertek" and "UDL" labels may have been double-strength tablets.  Until then, many patients and their families are left wondering if possibly related symptoms were caused by the use of these double-strength Digitek tablets.

14 responses to “Extent Of Digitek Recall Remains A Mystery Ten Days Later; Patients Are Left In The Dark”

  1. Karen Reynolds Avatar
    Karen Reynolds

    My father, who has a dementia diagnosis which admittedly complicates things, has taken DIGITEK for years. He started having the symptoms that have been posted now, approxiamtely 6 months ago. As of this e-mail….I have STILL NOT been notified by my pharmacist—WALMART—of the recall. I saw it on the local news on May 5th, 2008

    Reply
  2. Tom Lamb Avatar
    Tom Lamb

    I appreciate you sharing this information as we wait to hear how far back in time Actavis was having this manufacturing problem and making Digitek pills with double the intended dose of active ingredient.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  3. r. dugan Avatar
    r. dugan

    i’m with kaiser hmo in california and as of 5/8 nobody notified me. only found out because i went to their pharmacy to renew digitek. they gave me lanoxin instead.

    Reply
  4. HAROLD DYER Avatar
    HAROLD DYER

    I get my meds from Aetna Health and I haven’t been notified by phone by mail or by e-mail. My question is what am I supposed to dt to find out about my meds, after the 29th 0f April I just had a stent put in. Please Reply

    Reply
  5. Tom Lamb Avatar
    Tom Lamb

    To Harold:
    You should contact the prescribing doctor’s office now, it seems to me, rather than use the rest of your current supply of Digitek pills (if that is what you are asking about…).
    It is important to keep in mind that the FDA advises that no patient should stop taking any prescription medication without talking to the doctor who prescribed the drug.
    As shown by the last couple of comments, two weeks after the April 25, 2008 recall announcement some people have not been contacted and told that they should stop using their current supply of Digitek pills because they might contain twice the amount of active ingredient than they should. As such, some people are still at risk of over-dosing on digoxin and developing digitalis toxicity.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  6. Maritz Avatar
    Maritz

    My father has been takeing digetek for 158 days and the symptoms of severe lack of appetite occurred 20 days ago. The first symptom was, he was not feeling well & had a slight fever (38 deg) and after a week the lack of appetite occurred. Do I rush him to the hospital?

    Reply
  7. Tom Lamb Avatar
    Tom Lamb

    Of course, concerns and questions concerning your father’s use of Digitek and his health are better directed to his doctor. I am not in a position to give any medical advice.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  8. Jane Avatar
    Jane

    My dad complained of the symptoms off and on the past year — he was 91. Hearty for a 91 year-old, he died in March during a hospitalization in which the cardiologist was adjusting dad’s meds, which seemed strangely out of whack. Nonetheless, both Walgreen’s and Merck (by mail pharmacy) contacted my mother about the recall after his death.
    If you know of a loved-one who takes Digitek, check the meds or have your pharmacist do so.

    Reply
  9. Tom Lamb Avatar
    Tom Lamb

    While I know Actavis and Mylan are attempting to collect all Digitek pills produced since March 2006, I am advising anyone who suspects there was an injury or death caused by use of Digitek to retain possession — but clearly mark “Do Not Use” — of all remaining pills for possible evidence in any legal claim that may be filed.
    My law firm is representing people who have been hospitalized or died due to digoxin toxicity (also known as digitalis toxicity or poisoning) or other serious side effects associated with Digitek.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  10. D, Starr Avatar
    D, Starr

    My grandmother’s story has an uncanny resemblance to Tom Lamb’s June 11th posting so it doesn’t warrant repeating….My grandmother was not acting at all like her usually whip-smart self and I had a strange feeling about the medicines she was taking. The were making her very confused, taking her apatite away, and she was having hallucinations at night. She also had a renal stint.
    She died in February and we just received the notification from Walgreens this week.

    Reply
  11. Tom Lamb Avatar
    Tom Lamb

    I am sorry to hear about the death of your grandmother.
    As mentioned previously, my law firm is representing people who have been hospitalized or died due to digoxin toxicity (also known as digitalis toxicity or poisoning) or other serious side effects associated with Digitek.
    One way to have us consider a possible Digitek case is to submit a free online Case Evaluation Form:
    http://www.druginjurylaw.com/DigitekEvaluation.html
    In the alternative, you can call us on our toll-free number: 800-426-9535.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  12. Leah Avatar
    Leah

    My mother has recently past away while living in healthcare facility. I took my mother to her doctor for a check up in Augst and the dr. asked if she had quit taking digitek. I told him I was not told that the medicine had been discontinued. The lab that the facility uses drew blood the same day that I took her to the dr. and there was no trace of digitek. The dr. was concerned and sent her to his lab which the results showed 0.8 in her system. So i’m not sure what could have happened. I don’t know if this could have any effect on her death, the dr. was called by the facility of her death and the dr. put Acute Heart Arithmia.
    Clueless in KY

    Reply
  13. Alice Allen Avatar
    Alice Allen

    I started taking digitek 11/07. I had an ablation done on my heart 1/08 and it took about a month to recover. A couple of weeks later, I started feeling horrible. Headache, dead tired, heart would pound when I walked from one room to another. I am only 57 years old and this wasn’t normal for me. When I was contacted by Medco I wasn’t upset, but glad that there was a reason I was feeling so bad. I started feeling better within a week or so of changing to lanoxin. A month later when I saw my cardiologist, he sent me for a blood test for my digoxin level and it was normal. I was told by Medco that my batch was affected. Why would my digoxin level not be high? Are there longterm affects? I have tried to ask my doctors but I believe they are cautious because of a possible lawsuit. Little do they know that if they were up front with me I wouldn’t consider a lawsuit. But I can’t get answers.
    Do you know where I might get this information. I believe the pharmaceutical company should be punished. They do consider our suffering insignificant. I did not die. I don’t know if there is longterm damage. I DO know, I was so sick and worried and now I worry if there are longterm affects. Whether there are or not, I worry, and I cannot get (what I feel is an honest answer) from my doctors. I am not the type to file a lawsuit because someone made a mistake. I don’t think that it would be advantageous monetarily in the end. I am considering a lawsuit because I am so tired of feeling like a victim when I only want to be dealt with honestly.

    Reply
  14. Tom Lamb Avatar
    Tom Lamb

    Alice:
    If you did not get tested during the time you were taking the defective “double-dose” Digitek pills but, instead, only were tested later when you were taking the normal Lanoxin pills it is not surprising that your digoxin level was normal.
    If you would like to speak with us about a possible Digitek lawsuit, you can call us (1-800-426-9535) or complete an online Digitek Case Evaluation form, available at:
    http://www.druginjurylaw.com/DigitekEvaluation.html
    This same offer to investigate a possible Digitek case goes out to others who believe they suffered side effects and symptoms consistent with digoxin toxicity.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply

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