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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 10 of 10. This is the beginning of the thread.
Posted by ttee on August 15, 2006, at 22:37:15
1: Clin Gastroenterol Hepatol. 2006 Jul;4(7):912-7. Epub 2006 Jun 22. LinksCase report: fulminant hepatic failure involving duloxetine hydrochloride.
· Hanje AJ,
· Pell LJ,
· Votolato NA,
· Frankel WL,
· Kirkpatrick RB.
Department of Internal Medicine, Division of Digestive Health, The Ohio State University, Columbus, Ohio 43210, USA. jim.hanje@osumc.edu
BACKGROUND AND AIMS: Duloxetine hydrochloride was approved by the Food and Drug Administration in August 2004 for the treatment of major depressive disorder and diabetic peripheral neuropathic pain. Initial product labeling contained a precaution regarding the risk for increases in liver function test results. Recently, postmarketing research has revealed episodes of cholestatic jaundice and increases in transaminase levels to greater than 20 times normal in patients with chronic liver disease. METHODS: In this case report, we describe a patient with non-Hodgkin's lymphoma in remission and depression treated with duloxetine and mirtazapine. RESULTS: Approximately 6 weeks after increasing her duloxetine dose from 30 to 60 mg daily, she became jaundiced and presented with fulminant hepatic failure. Liver function tests immediately before initiating duloxetine were not available, although the patient carried no prior history of chronic liver disease. A complete work-up for alternate causes failed to reveal another explanation for the patient's clinical presentation. A liver biopsy examination showed histologic changes of subacute injury and the patient's clinical course was consistent with drug-induced liver injury. Despite aggressive measures, the patient's condition deteriorated and the decision was made to withdraw care. CONCLUSIONS: This report shows a case of fulminant hepatic failure and death involving duloxetine use. Given recent reports of severe hepatotoxicity associated with the use of duloxetine in patients with pre-existing liver disease, further investigation into the safety of this compound is warranted.
PMID: 16797245 [PubMed - in process]
Posted by Phillipa on August 15, 2006, at 22:58:13
In reply to Cymbalta - More Trouble With This Compound, posted by ttee on August 15, 2006, at 22:37:15
Guess I'm glad I couldn't tolerate it. Love Phillipa
Posted by llrrrpp on August 16, 2006, at 0:24:50
In reply to Re: Cymbalta - More Trouble With This Compound » ttee, posted by Phillipa on August 15, 2006, at 22:58:13
Guess I'm glad I have a healthy liver.
-ll
Posted by silvercoin on August 16, 2006, at 8:22:35
In reply to Cymbalta - More Trouble With This Compound, posted by ttee on August 15, 2006, at 22:37:15
>
> 1: Clin Gastroenterol Hepatol. 2006 Jul;4(7):912-7. Epub 2006 Jun 22. Links
>
> Case report: fulminant hepatic failure involving duloxetine hydrochloride.
>
> · Hanje AJ,
>
> · Pell LJ,
>
> · Votolato NA,
>
> · Frankel WL,
>
> · Kirkpatrick RB.
>
> Department of Internal Medicine, Division of Digestive Health, The Ohio State University, Columbus, Ohio 43210, USA. jim.hanje@osumc.edu
>
> BACKGROUND AND AIMS: Duloxetine hydrochloride was approved by the Food and Drug Administration in August 2004 for the treatment of major depressive disorder and diabetic peripheral neuropathic pain. Initial product labeling contained a precaution regarding the risk for increases in liver function test results. Recently, postmarketing research has revealed episodes of cholestatic jaundice and increases in transaminase levels to greater than 20 times normal in patients with chronic liver disease. METHODS: In this case report, we describe a patient with non-Hodgkin's lymphoma in remission and depression treated with duloxetine and mirtazapine. RESULTS: Approximately 6 weeks after increasing her duloxetine dose from 30 to 60 mg daily, she became jaundiced and presented with fulminant hepatic failure. Liver function tests immediately before initiating duloxetine were not available, although the patient carried no prior history of chronic liver disease. A complete work-up for alternate causes failed to reveal another explanation for the patient's clinical presentation. A liver biopsy examination showed histologic changes of subacute injury and the patient's clinical course was consistent with drug-induced liver injury. Despite aggressive measures, the patient's condition deteriorated and the decision was made to withdraw care. CONCLUSIONS: This report shows a case of fulminant hepatic failure and death involving duloxetine use. Given recent reports of severe hepatotoxicity associated with the use of duloxetine in patients with pre-existing liver disease, further investigation into the safety of this compound is warranted.
>
> PMID: 16797245 [PubMed - in process]
>
>
>
Concomitant use of alcohol seems to be a big risk factor with the liver issues seen with this drug. I read up on Cymbalta in June before deciding to go with Marplan this time and was somewhat surprised that this stuff is even on the market given the relatively high incidence of liver problems. They are certainly much more common than the hepatotoxicity seen with the MAOI hydrazine derviatives or with Serzone/nefazodone.Todd
Posted by ttee on August 16, 2006, at 10:28:25
In reply to Re: Cymbalta - More Trouble With This Compound, posted by silvercoin on August 16, 2006, at 8:22:35
Guess I should sell my Lilly stock.
Posted by yxibow on August 17, 2006, at 1:50:03
In reply to Cymbalta - More Trouble With This Compound, posted by ttee on August 15, 2006, at 22:37:15
>
> 1: Clin Gastroenterol Hepatol. 2006 Jul;4(7):912-7. Epub 2006 Jun 22. Links
>
> Case report: fulminant hepatic failure involving duloxetine hydrochloride.
>
> · Hanje AJ,
>
> · Pell LJ,
>
> · Votolato NA,
>
> · Frankel WL,
>
> · Kirkpatrick RB.
>
> Department of Internal Medicine, Division of Digestive Health, The Ohio State University, Columbus, Ohio 43210, USA. jim.hanje@osumc.edu
>
> BACKGROUND AND AIMS: Duloxetine hydrochloride was approved by the Food and Drug Administration in August 2004 for the treatment of major depressive disorder and diabetic peripheral neuropathic pain. Initial product labeling contained a precaution regarding the risk for increases in liver function test results. Recently, postmarketing research has revealed episodes of cholestatic jaundice and increases in transaminase levels to greater than 20 times normal in patients with chronic liver disease. METHODS: In this case report, we describe a patient with non-Hodgkin's lymphoma in remission and depression treated with duloxetine and mirtazapine. RESULTS: Approximately 6 weeks after increasing her duloxetine dose from 30 to 60 mg daily, she became jaundiced and presented with fulminant hepatic failure. Liver function tests immediately before initiating duloxetine were not available, although the patient carried no prior history of chronic liver disease. A complete work-up for alternate causes failed to reveal another explanation for the patient's clinical presentation. A liver biopsy examination showed histologic changes of subacute injury and the patient's clinical course was consistent with drug-induced liver injury. Despite aggressive measures, the patient's condition deteriorated and the decision was made to withdraw care. CONCLUSIONS: This report shows a case of fulminant hepatic failure and death involving duloxetine use. Given recent reports of severe hepatotoxicity associated with the use of duloxetine in patients with pre-existing liver disease, further investigation into the safety of this compound is warranted.
>
> PMID: 16797245 [PubMed - in process]
>
>
>
>
One has to read case reports with a fine tooth comb. Thats what they are -- case reports, of one or several people. In fact all of what we talk about here on the medication side are our own case reports. Negative case reports are often discussed online more than positive reports, because if some medication is not causing side effects there are less reasons to complain or ask for advice.
I'm not saying that one shouldn't ignore these things. It is simple to get an ALT test for your liver functions, and I get tests regularly because I am on multiple medications (including Cymbalta.)
Also, the case report here mentions someone with a cancerous disease (already weakening the system) and not only on one antidepressant, but also on a second, Remeron. Most antidepressants and psychiatric medications pass through the P450 cytochrome system in the liver.
And it is also dare I say, prudent for doctors to practice CYA (cover your ***) medication in people with impaired liver function. You don't give nefazodone to someone who has complex cirrhosis.
While liver disorders are something to absolutely avoid obviously, there are signs oneself can see rather early on to avoid liver damage. It is one of the organs in the body that greatly repairs itself, and with supportive care, one can survive for quite some time on 5% to 10% of it. Jaundice shows up rather early on, with yellow bruising and eye color changes and partial liver transplants are much more common and routine, if there is such a word, now.
I guess what I'm saying is that all medications have side effects and there are choices to take or not take, and most go through the liver through a complex system that all doctors need to be aware of, the P450 cytochrome, with few exceptions such as the benzodiazepine Serax which largely goes through the kidneys.
Posted by flmm on August 17, 2006, at 20:18:01
In reply to Re: Cymbalta - More Trouble With This Compound, posted by yxibow on August 17, 2006, at 1:50:03
I agree with you yxibow! I have been on many meds including serzone.I am now on cymbalta. I always get my liver checked, never had a problem! I also do not drink alcohol which I suspect plays a major part in these problems! Better be safe but a few negative do not discount a valuable medication. Only the negatives are talked about....
Posted by ttee on August 17, 2006, at 21:39:04
In reply to Re: Cymbalta - More Trouble With This Compound, posted by flmm on August 17, 2006, at 20:18:01
Your right, it only takes one to ruin things for everyone. Although, I bet the poor women that died would have appreciated an extra sentence in the PI that directs the prescribing physician to order periodic liver function tests and obtain a baseline LFT's before prescribing. Interesting to note that Serzone didn't get black boxed and abandoned by the manufacturer until the drug was nearly off patent and at the end of its gravy train. As you know, it can take over 7 years past FDA approval for serious problems with a med to start to surface.
Personally, I experienced a 5 times over the upper limit range ALT/AST when I took Cymbalta. I was taken no other meds with it. I don't drink any ETOH. Unlike the women that died, I did obtain a complete blood test including LFT's before going on Cymbalta. My baseline LFT's were fine. After I discontinued Cymbalta, my LFT's returned to normal again in about 4 weeks. The ER filed a MedWatch report to the FDA about what happened with me with Cymbalta, and because I had no other illness, didn't drink ETOH, improved immediately upon discontinuation of the med, the is little doubt that it could have been from anything but Cymbalta. I am currently on Lexapro and get LFT's frequently now and have no seen any more acute elevations. I am sure that my experience was rare as was the poor women that died. I am lucky that I recognized the symptoms of liver dysfunction and got to the ER without delay and received proper treatment, in this case discontinuation of the med. Had I listen to my psychiatrist on the telephone, his advise was to increase the dose of Cymbalta and that my symptoms were just side effects or just plain symptoms of depression. It was not long after they submitted the MedWatch report to the FDA, that they manufacturer came out with the stronger liver warnings for Cymbalta. I know I am not alone for them to do so.
Posted by Cairo on August 18, 2006, at 10:16:07
In reply to Cymbalta - More Trouble With This Compound, posted by ttee on August 15, 2006, at 22:37:15
Some people will have idiopathic liver failure from many drugs and I believe I read that you can't predict who this will happen to. It's unfortunate, but you can't generalize to the rest of the population. Liver function testing should be done.
Cairo
Posted by invisibleman15010 on August 21, 2006, at 16:25:48
In reply to Re: Cymbalta - More Trouble With This Compound, posted by Cairo on August 18, 2006, at 10:16:07
Scary, but odd I remember reading almost the same type of report on Effexor, one of the reasons I was scared off of it.......there are so many negatives for each and some,maybe less positives...I started asking my GP for liver panel tests and cholesterol every six months, kinda sad my Psy. doc. nevers questions any of that. I know my Cholesterol skyrocketed while on Effexor. My GP did not want to add a statin because of all of the meds I was on. So I added Omega 3 and Niacin and it did help bring it down. So many side effects, who knows what the real long term effects are.
e
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