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Antibiotic Avelox Linked To Severe Liver Injury Side Effects, Again

Will The FDA Be The Last To Insist On Increased Warning; In Fall 2007 Bayer Updated Its Avalox Label In Europe

(Posted by Tom Lamb at DrugInjuryWatch.com)

On March 22, 2010 Health Canada issued a press release, "Updated Labelling for Antibiotic Avelox (Moxifloxacin) Regarding Rare Risk of Severe Liver Injury Information Update", which informed doctors and patients about newly updated labeling information for Avelox in Canada that incorporates important safety information related to the rare risk of severe liver problems when using Avelox.

Symptoms of liver problems include:

  • Abdominal pain;
  • Loss of appetite;
  • Yellowing of the skin and eyes;
  • Severe itching;
  • Dark urine; and,
  • Pale-colored stools.

In its March 2010 press release about Avelox, Health Canada advised: 

Patients who experience any of these symptoms are advised to stop taking Avelox and contact a health care professional immediately.

While this advisory from Health Canada about Avelox is important, it is far from new.

In an article which we posted to this site more than two years ago, "February 2008 'Dear Doctor' Letter About Avelox / Avalox Is Sent By Bayer In Europe", we reported that this letter from Bayer to doctors in Europe was intended to emphasize the addition of a warning about severe, possibly fatal liver injury to the package insert, or label, for Avalox (slightly different brand name for this antibiotic is used in the European Union) back in the fall of 2007.

We concluded our February 2008 article about this Avalox "Dear Doctor" letter that Bayer sent out only in Europe with this remark:

We will watch for any similar Avelox "Dear Doctor" letter from Bayer here in the U.S.

Two years later, we are still waiting and watching, here.

It is unclear thus far whether Bayer will notify doctors in Canada by letter about the Avelox label change concerning the risk of liver injury for patients using this apparently unsafe antibiotic.

Here's our "obvious" question to the FDA, now:  Is the FDA looking at Avelox for serious side effects such as drug-induced hepatitis and liver failure, which seem to be unique to this antibiotic among the fluoroquinolones?

We would like to hear about what you know regarding this liver-related Avelox safety issue.  As always, please share by leaving a Comment, below.

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7 responses to “Antibiotic Avelox Linked To Severe Liver Injury Side Effects, Again”

  1. Mark Anderson Avatar
    Mark Anderson

    I had every one of the symptoms relating to avelox and its effect on my liver. I was taking avelox for about three weeks for a sinus infection when the symptoms occurred. It was this article that allerted me to the side effects. Naturally I quickly stopped taking the drug and the symptoms went away within a day.

    Reply
  2. Tom Lamb Avatar
    Tom Lamb

    Mark:
    Thanks for sharing your experience with Avelox.
    You probably already have done so, but if not, be sure to let your doctor(s) know about the symptoms which you developed while taking Avelox.
    I hope you continue to read Drug Injury Watch.
    Tom Lamb

    Reply
  3. Nancy Avatar
    Nancy

    I took one Avalox tablet today, and was rushed to the Emergency Room within an hour. I had a “sunburn” rash that covered my entire body, I was having trouble breathing, I had swelling of my face and burning sensation on my feet and hands and in my ears and in my mouth. I felt like I was burning from the inside out I had tightness in the chest nausea, vomiting, and became very restless. Now my skin looks a little yellow.

    Reply
  4. Tom Lamb Avatar
    Tom Lamb

    Nancy:
    Sorry to hear about this apparent adverse reaction to Avelox.
    What diagnosis was made at the Emergency Room? Were you admitted to the hospital from the ER?
    Are you continuing under the care of a doctor for the conditions you described?
    You can provide this additional information, if you wish, by sending me a private email (druginjury@gmail.com) or you can post another Comment, below.
    Tom Lamb

    Reply
  5. Lory Avatar
    Lory

    I have been taking Avelox for only three days now and woke up this morning with severe vomitting and diareha. I have a taste in my mouth as if it is bile from my liver. Is this a side effect that is known?

    Reply
  6. Tom Lamb Avatar
    Tom Lamb

    Lory:
    Please understand that I am only an attorney and not a physician, I cannot give any medical opinion nor advice.
    I suggest you contact one of your doctors as soon as possible if these symptoms persist.
    Tom Lamb

    Reply
  7. Rose Marie Avatar
    Rose Marie

    Will be consulting my physician for similar symptoms – skin rash which lasted several hours after 24 hour use. I am into my third day and am experiencing numbness in my lower limbs and discoloration in my urine.
    I have decided discontinue this medication.

    Reply

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