FDA Issues Liver Warning for Cymbalta

Patients With Liver Disease May Risk Further Liver Damage, Says FDA

By Miranda Hitti
WebMD Medical News Reviewed By Louise Chang, MD
on Monday, October 17, 2005

Oct. 17, 2005 -- The FDA and Eli Lilly and Co. have issued a new warning about Cymbalta, a drug used to treat depression and pain associated with diabetic peripheral neuropathy.

"Postmarketing reports of liver injury (including hepatitis and cholestatic jaundice) suggest that patients with pre-existing liver disease who take [Cymbalta] may have an increased risk for further liver damage," says the FDA.

New labeling will extend the precaution against using Cymbalta in patients with substantial alcohol use to include those with chronic liver disease.

"It is recommended that Cymbalta not be administered to patients with any [liver] insufficiency," says the FDA.

Maker's Letter to Doctors

About a million people have taken Cymbalta since the drug's approval in 2004, according to a letter to doctors sent by Lilly, Cymbalta's maker.

"Among these, several cases of [liver] injury have been spontaneously reported," states Lilly's letter.

"Some of these patients had underlying liver disease. Review of these cases suggests that patients with underlying chronic liver disease may be at increased risk of [liver] toxicity with [Cymbalta]," the letter continues.

Lilly is a WebMD sponsor.

Symptoms

Signs and symptoms of liver damage can include dark urine, jaundice (yellowing of the skin and eyes), itchiness, abdominal tenderness in the liver area, or unexplained flu-like symptoms. Elevations of liver enzymes may be found on blood tests.

Lilly asks that any questions about the warning be directed to Lilly's medical department at (800) Lilly-Rx ((800) 545-5979).

Report any Cymbalta side effects to Lilly at (800) Lilly-Rx ((800) 545-5979) or to the FDA's Medwatch program at (800) FDA-1088 ((800) 332-1088) or online at www.fda.gov/medwatch.

SOURCES: FDA Medwatch 2005 Medical Product Safety alerts: "Cymbalta." Eli Lilly and Company: "Dear Health Care Professional."

Thanks for the information, Lindsay. I heard this on this forum, months ago and had my liver tested then. It's just a blood sample and you get the results in a couple of days.

This is the first time I have seen the warning, Lindsay!

We really appreciate that you are on top of things!

Thanks for the information and warning! I was just prescribed this yesterday, started it today! I'll definitely have to keep an eye out!

I'd wait a couple of months, then get it checked. Good luck with the Cymbalta.

I am taking Cymbalta along with my mother. We need to take this under advisement. Mom has had hepatitis in the past so the warning is more ominous for her.

Swede

Just ask for a liver panel, Dogg. It's a blood test and tells about your liver function.

And I agree. It's an expensive med!

i started this medication about 6 months ago and ive had my liver checked and things came back normal. thanks for this information its a thing i have to keep an eye on as im a alchoholic.

This med may cut your craving for alcohol down. I know I rarely drink, and I never finish whatever I started. I just don't get the same old reaction to alcohol as I did in the past, and find that the headache that comes with it isn't worth it.......

Jackie

Pretty scary. I have had blood tests performed by my doctor and everything is OK, but I worry about long term effects of taking this or any anti-depressant. I wish I did not have to rely on medication to feel "normal" and happy.

We all understand that concept, but knowing that a med is hard on any particular organ is where it's at. I'm thinking that I probably need to get this test performed, once again. It's been years, you know?

Jackie

Probably a good idea for anyone to get their liver tested every few years while taking Cymbalta.

Hey everybody, I just wanted to let you all know that I had been on Cymbalta for 1yr and about 3months and my Liver Enzymes were elevated two weeks ago. When my doctor called to tell me about the results, he didnt he realize it could be Cymbalta doing it! I suggested it and so he said " The only way to know if its that is to take you off of it" DUH! He called me in Prozac and so i switched over the next day( not doing well but not horrible iguess) My ANA titer was also positive but im not sure if that had anything to do with the Cymbalta. I just started really being tired all the time and just felt sick a lot, itchy, nauseated, felt i was bloated and swollen a lot. Of course, i gained about 25 pounds also in the last year. Anyway, I went to the doctor with a list a mile long of the symptoms id been having so he ran a million tests and found it was my liver. I go back this week to see if they are still elevated or whatever but won't know for about another 2 weeks i guess. I will post back when i find out...

OK, I guess I am the same way, I like to have a glass of wine everynow and then, but since I have been on this med, I have a headache with just half a glass, and its not worth it, I hate getting up at 4:15 in the morning to go to work, and having a headache makes it even worse!

I will never take cymbalta again - this is not the first "warning" related to the drug. As you see on their commercials (now) they say do not take with migraine medicines. Well, I cannot prove it, but I sincerely believe that taking a combination of cymbalta and axert (for migraine) caused a blood clot that ended up in my right eye, which is now permanently damaged. It could have been worse though - if the clot went to my brain (stroke out) or my heart (heart attack).

I am so sorry to hear that this combination of meds resulted in this happening to your eye. I don't know how this happened if it's a warning by the company and your doc must have read this? What a terrible outcome to have to deal with!

Let this be a lesson to all of us! Read those inserts about other meds that you are on and other conditions that you have!!!

Have a liver panel done if this is a concern to you. It's just a simple blood test and it's worth the blood draw.


Any med we take can cause problems in the liver as that's where your system detoxifies meds.

Jackie

Hi, its 7upanddown again....Since January 2008 i became lethargic, sick feeling, bloated, etc..After all tests I was diagnosed with Drug Induced Lupus!!! I was completely taken off cymbalta, although it took me several attempts. Not to mention the TERRIBLE withdrawal symptoms. I was then placed on Prozac 20mg. My ANA titer is now negative and all blood tests are normal! The symptoms were quite vague so PLEASE KEEP A CHECK ON YOUR BLOOD b/c I just thought i was exhausted and sick from the stress of college. Cymbalta was the best antidepressant but it could have caused me a lifetime of physical illness.

I'm really sorry to hear you have had these results and that the cause was Cymbalta. I had my annual blood work and liver enzymes checked in March and thankfully all was normal. jI think anyone on ADs should make this a part of their annual checkup. I hope you start to feel better!

....Thanks for the Info...I am on that drug....IM

Hi I was diagnosed with depression and was put on Zoloft. The Zoloft didn't help much & my symptoms worsened, especially the addition of severe joint pain. The doctor then changed me to Cymbalta. It worked fantastic for approximately 1 & 1/2 years. Then I began to have increased depression symptoms again. I continued the Cymbalta, but sought doctors care once again. I went into a severe depression, then began hallucinating, just at night. The doctor wanted to double my Cymbalta, but I held off instead asking to talk to mental health. That didn't help much, I began thinking I caused doom for people around me, some even 1000's of miles away. I am an college educated health professional. Part of my mind told me I was at fault & the other part tried to reason with me. My mom got into a bad car accident far away from me & I thought I caused it. I couldn't work safely and lost my job. The doctor then actually wrote me a prescription for Zyprexia, diagnosing pyschotic depression, but I couldn't get myself to fill it. I started to think everyone would be better off if I weren't around. Then I didn't have the money to buy the Cymbalta, so I stopped it cold turkey. The hallucinations & feelings of doom completely went away within 2 weeks, my mind started clearing up. Throughout this whole ordeal I had no support from my husband or my middle daughter. My son just steered clear of me. The only one who showed any support was my oldest daughter and she had many health issues of her own, I didn't want to burden her. I have talked with another doctor who told me that if the prior doctor had doubled my Cymbalta I probably would not be here today. I still have depression, bawling my eyes out just writing this, lack of motivation ect... but my thinking is clear. Today I do not take anything. My biggest problem is that I am still so angry with my family that did not support me. I am trying to find a way to forgive them. I saw the report side effects to Lilly & I copied it to contact them tomorrow. I have been having right upper quad pain and intermittent episodes (I think) of jaundice, so I am going to ask my doctor to test my liver. I believe my adverse reaction to Cymbalta could partly have been due to genetics as my sister had similar problems with other medications.

I've been taking Cymbalta for about a year now. I was warned, not by my prescribing GP about the liver concerns, but by my counsellor. I've not had any problems with liver levels, etc. The drug helped with the depression very shortly after initially taking it, and has been the best anti-depressant drug I've been on regarding effectiveness and the lack of side-effects.

What were the withdrawal effects? I will consider going off in the future.