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Eli Lilly Sends “Dear Doctor” Letter Regarding Cymbalta and Liver Injury

FDA Warning: Cymbalta May Cause Liver Damage For Patients With Chronic Liver Disease

On October 17, 2005 the FDA and Eli Lilly & Co. said in a MedWatch drug alert that the antidepressant Cymbalta (duloxetine hydrochloride) should not be used in patients with preexisting liver problems because Cymbalta might worsen the underlying liver condition.

The package insert, or label, for Cymbalta had already warned about the possibility of liver injury.  In an October 5, 2005 "Dear Doctor" letter, Lilly is informing prescribing doctors that patients with underlying liver disease should not be prescribed Cymbalta based on "several reports" of liver injury made to the FDA and Lilly.  There have also been reports of Cymbalta-induced jaundice, a liver disorder that can cause the yellowing of the skin and eyes. "Review of these cases suggests that patients with underlying chronic liver disease may be at increased risk" of liver damage with Cymbalta, Lilly said in the Dear Doctor letter.

This October 5 letter from Lilly also advises doctors not to prescribe Cymbalta to patients "with substantial alcohol use" because postmarketing drug-safety studies have shown that some patients experienced liver damage when they consumed Cymbalta and alcohol.

The FDA MedWatch safety alert for Cymbalta, which was posted on the FDA’s web site on October 17, said that Cymbalta has been associated with increased risk of liver injury in patients with chronic liver disease.  In relevant part, the MedWatch alert stated:

Postmarketing reports of hepatic injury (including hepatitis and cholestatic jaundice) suggest that patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage. The new labeling extends the Precaution against using Cymbalta in patients with substantial alcohol use to include those patients with chronic liver disease. It is recommended that Cymbalta not be administered to patients with any hepatic insufficiency.

Cymbalta was first approved by the FDA in August 2004 to treat major depressive disorder. Since then the FDA has approved Cymbalta for treatment of diabetic peripheral neuropathic pain, or nerve pain associated with diabetes. More than one million patients have been prescribed Cymbalta, according to Lilly.

(Posted by: Tom Lamb)

18 responses to “Eli Lilly Sends “Dear Doctor” Letter Regarding Cymbalta and Liver Injury”

  1. l. harris Avatar
    l. harris

    i took Cymbalta from May to Aug. 2005, i think it may be the cause of my neurological problems,last year my liver function was bad, while on cymbalta, then i had tremors and symptoms of MS. could this be serotonin syndrome? I still have no answer and am still looking for HELP ! i hurt all over.

    Reply
  2. S. Hart Avatar
    S. Hart

    I have been taking Cymbalta for quite some time and recently had a health risk assessment done thru my employer and just received the results last night in my email. It has shown very high alert level GGT, AST, and ALT. I also have tremors, dizzy spells, hurt all over, and have gained quite a bit of weight. I am not a heavy or even a moderate drinker and I have never had liver disease. I am worried about what this means and will make an appointment with my doctor as soon as possible.

    Reply
  3. Tom Lamb Avatar
    Tom Lamb

    I appreciate you taking the time to share your experience with Cymbalta.
    Hopefully your prompt attention to the elevated liver function tests will help avoid any serious liver damage.
    Keep in mind that the FDA advises patients not to stop taking any prescription medication without first talking to their doctor.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  4. jackie Avatar
    jackie

    I have have Hep C in the past and went hrough the intreferon treatments and it was effective, however, I am VERY concerned as t what effect Cymbalta may do to activate Hep C symptoms again. Any info on this would be greatly appricated.

    Reply
  5. Tom Lamb Avatar
    Tom Lamb

    As I am not a medical doctor, I am not in a position to give you any real guidance as regards this inquiry.
    I suggest you raise your concerns with the doctor prescribing Cymbalta or get a “second opinion” from another doctor.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  6. Sara Avatar
    Sara

    I have been experiencing extreme fatigue about 2 days after drinking only 2 beers. I have been on cymbalta for 1 year. Is there a correlation?

    Reply
  7. Tom Lamb Avatar
    Tom Lamb

    This question is probably more appropriate for the doctor who has prescribed you the Cymbalta and/or another one of your doctors.
    I will share with you that I see a lot of searches for “cymbalta and alcohol” by internet users, which makes me think that others have similar concerns.
    Be careful and best of luck to you.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  8. Mary Avatar
    Mary

    I have been on Cymbalta for three years, and take only 30 mg. per day. I have recently noticed cravings for alcohol that I did not experience previously…and when I start drinking I keep going till all the alcohol is gone…often meaning 12 beers or two bottles of wine. Other web postings seem to mention the same thing. I am going to see my doc right away.

    Reply
  9. Tom Lamb Avatar
    Tom Lamb

    I much appreciate you sharing this experience with us.
    As stated above, others seem to be searching for information about Cymbalta combined with alcohol use.
    Hopefully your doctor can help you avoid any possible serious problems due to this combination.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  10. lynn Avatar
    lynn

    I have been on cymbalta for over a year. I don’t remember anyone telling me not to drink alcohol with this drug and I do have anywhere from 1-3 drinks one night on the weekends. I also recently was prescribed lamisil by my podiatrist. He clearly told me not to drink alcohol on lamisil but now I’m worried about hepatic metabolism inhibition that I just read can occur between cymbalta and lamisil. Will lamisil still work? Am I harming my liver by taking these two drugs if I don’t drink?

    Reply
  11. Tom Lamb Avatar
    Tom Lamb

    Sorry for the delayed response.
    As I am only an attorney, I cannot answer your medical questions. It would be best to discuss your issues with the doctor(s) who prescribed the drugs you mentioned.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  12. jean Bergeron Avatar
    jean Bergeron

    Are any of these drugs really researched long enough? Or just testing them the fda acts like they are the good house keeping seal!

    Reply
  13. donna Avatar
    donna

    I too had tremors and spasms while on cymbata nuero probe and liver disease.since stopping cymbalta I feel better but I am left with some damage….i was not informed and if I complained I was told it cant be the cymbalta..well why then do I feel better now that im off that poison

    Reply
  14. Kathy H Davis Avatar
    Kathy H Davis

    Today my doctor put me on cymbalta I have liver deaseas why did he give it to me

    Reply
  15. Patricia Coppedge Avatar
    Patricia Coppedge

    I was prescribed Cymbalta in Oct 2012 and went into liver failure in Feb 2013. My health continues to decline with being diagnosed with chronic pancreatitis in Feb. 2013 and now Thrombocytopenia Purpura in 2016. I have not felt well since the liver failure adverse drug event in 2013.
    I am seeking help from an attorney or law firm regarding malpractice or product liability against Cymbalta and Eli Lilly with respects to adverse drug reactions, such as: liver failure.
    I recently read an article from the NIH about Cymbalta being prescribed to adults in their early 50’s. Approximately 48,000 cases of liver failure and pancreatitis have been reported in adults in their early 50’s prescribed Cymbalta.

    Reply
  16. Tom Lamb Avatar
    Tom Lamb

    Thank you for your Comment.
    I suggest you contact a medical malpractice attorney in the state where the doctor(s) prescribed you the Cymbalta.
    I wish you the best in all aspects going forward.
    Tom Lamb

    Reply
  17. wendy west Avatar
    wendy west

    i have been taking cymbalta for maybe 4 years now. this last year i have been tired all the time with stomach issues dizziness brusing mood swings etc. ive been complaining to my doc about it for the intire time. he has tested me for liver disease and kidney failure which led to a diagonise of nafld. i dont drink. perhaps one glass of wine a year. i have not had any issues with my liver in my life. nothing was mentioned about cymbalta. as the year progressed my tiredness and stomach pain increased leading to many visits to the er. they tried to do a colanoscopie but were unable to complete it. they have done a crt scan and a berium ennama test all inconclusive. again no one mentioned any connextion to cymbalta tho they ALL knew i was taking it. i take cymbalta for bipolar desease. my mood swings this year have been extreame. i would go into states of sub psycotic rage. these would last for days then all of a sudden i would just come out of it but i would be extreamely tired. i would sleep for about 36 hours. unable to do anything but sleep. i almost lost my job it was so bad. my doc told me i would probablly never find out why it was happening. just this month i noticed it would happen when i would forget to take my meds. i have a long term issue with forgeting meds when life gets hard. my doc knows this. since then i have eased off of cymbalta very slowly (for me) over three weeks. i stopped completely when i was at one pill one day none of the second day. the day i took cymbalta i was sick. the day i did not take it i felt wonderful. 6 days without cymbalta at all and i have near normal bowel movements after 3+ years of very loose movement with blood i can wake up in the morning and sleep at night im happier and i work better also i have no pain in my stomach any more. my boss says its like “getting the old wendy back” on the down side i have pins and needles in my right hand almost all the time. at night my hands and ankles ache and i have headaches on long work days (10-14 hour days)
    one more thing i have noticed, this last year my dog who is very attached to me has more often then not slept in the livingroom instead of in my bedroom. 2 days after stopping cymbalta completely she is now back in my room nightly and sleeps against my back like she always did. not on the floor as she has been the last year when she would sleep in my room.

    Reply
  18. Jennifer Marie Avatar
    Jennifer Marie

    Hi wanted to see where you…out are today health wise. Im trying to wean myself off cymbalta now.

    Reply

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