FDA Broadens Liver Warning for Cymbalta

Discussion in 'Fibromyalgia Main Forum' started by Jgavi, Oct 29, 2005.

  1. Jgavi

    Jgavi New Member

    Not sure if everyone saw this- I just found out, so here it is again- i know many of us are on this drug!


    FDA Broadens 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 broadened a warning about possible liver problems with 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.

    Cymbalta's labeling previously noted possible liver problems. The label had warned that "Cymbalta should ordinarily not be prescribed to patients with substantial alcohol use." Now, that warning will read, "Cymbalta should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease," according to a letter to doctors sent by Lilly, Cymbalta's maker.

    "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 Lilly's letter.

    "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.




  2. fivesue

    fivesue New Member

    My doctor was going to switch me from Effexor to Cymbalta, and after hearing the warnings even though I have no liver disease, I don't choose to take it. I take other meds so if this one is hard on livers, put it together with other meds and it may be a big problem.

    So, I'll stick with Effexor. I am having a bit of a problem with depression, but think I'll just gut it out. Better than killing my liver.

    Thanks again.

    Sue
  3. dafoefan

    dafoefan New Member

    I changed from Effexor XR to Cymbalta. It lasted about 6 weeks for me, I felt the worst I have since I first got sick. I am so extra glad I went off it. I'd rather be a little depressed on Effexor XR than virtualy bedwritten with Cymbalta. And with the side effects, yikes. Definitely not the med for me!
  4. jaltair

    jaltair New Member

    . . for making sure that their bodies are healthy enough to take ANY type of drug.

    Every single drug we take has a multiple number of side effects. We take drugs to help our symptoms or diseases and have to be responsible to always weigh the benefits and the risks of taking anything. I'm tired of people constantly blaming the drug companies or government for problems that develop after they take drugs. People should know that any drug will possibly affect their liver as the liver is the filter for the body of anything that goes through the body. I just see the warning put out as another measure to assure that people are aware that they can't drink and take meds (duh!), or that if they have liver damage from past problems, that they should be very aware of taking anything. Personal responsibility!!!!

    A normal healthy liver can normally withstand the results of being on meds for health problems. Doctors do liver function tests regularly to monitor the function of the liver and even kidneys. If people are responsible for making sure that they see the doctor regularly and responsbile for taking care of their bodies, it won't be a problem.

    As for me, I think Cymbalta has been a Godsend! I had unrelenting migraines and after starting the Cymbalta, these horrible things stopped!

    Jeannette
  5. Mikie

    Mikie Moderator

    It is difficult to make informed decisions unless we are fully informed. It is no secret that the drug companies run multiple tests and cherry pick those which show their drugs in the best light for the FDA. In some cases, they know of problems with their drugs and choose not to inform the public or physicians until made to do so. In these cases, it is appropriate to hold the pharmaceutical companies and the FDA responsible if info was withheld.

    Some drugs are harder on the liver than others. It is not a bad idea to have liver panels run from time to time if one is taking meds. This is an important issue to bring up with one's doc.

    I choose to only take meds with a longer track record and all the recent problems with new drugs reinforces my decision. In addition, when I do take a drug, it is one I have researched to the best of my ability.

    Being responsible for oneself is a good idea and most of us try to do that, but we can only work with the info we have. We cannot depend on our docs because they get most of their info on meds from pharmaceutical reps. It is time that we, and the govt., demand full disclosure from pharmaceutical companies. Because of the HUGE contributions to political parties, pharmaceutical companies have been able to skate by while those responsible for representing us look the other way.

    It is this same govt. which allows the pharmaceutical companies to gouge us for drugs while selling them far cheaper in other countries. It is this same govt. which is shifting the cost of drugs for the medically indigent Medicare recipients from the pharmaceutical companies to the taxpayers and those on Medicare instead of using their clout to negotiate for lower prices for those on Medicare.

    Yes, we all have a responsibility for our own well-being and health but our govt. has a responsibility to act in our interest and represent us where we are unable to enforce laws and standards as individuals. That is what we elect them for. Unfortunately, it seems that govt. is more interested in representing those entities which contribute the most money.

    Most issues today are complex and just being responsible for self often isn't enough. If it were, we wouldn't need local, state, and federal govts.

    Love, Mikie
  6. cbella

    cbella New Member

    if you live in the states, you can go to the health dept. and request lab tests. We need to be responsible for our own health and not always let the dr. have the last say! I know after reading this, I'm going to make sure I have labs done by my doc or by the health dept. :)cb