Levaquin Removed From Market Quietly Amid Concerns Over Side Effects of Antibioitic: Report

A new report reveals that Johnson & Johnson’s Janssen Pharmaceuticals subsidiary quietly ceased production of Levaquin late last year, ahead of new label warnings recently required by federal regulators about potential mental health side effects linked to the controversial antibiotic. 

In what was effectively a silent Levaquin recall, RTV6 in Indiana reports that the drug maker discontinued production of both the oral and IV name-brand versions of Levaquin in December 2017, without any apparent public announcement about the decision.

Janssen also ceased production on Floxin Otic ear drops, which belongs to the same class of antibiotics as Levaquin, known as fluoroquinolones.

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The revelation comes just days after the FDA issued a drug safety communication warning new fluoroquinolone warnings, which would require Levaquin, as well as Avelox, Cipro and other members of the class, to carry new label information that indicates they may cause mental health problems, as well as significant decreases in blood sugar. Those warnings were the latest in a string of serious health risks linked to the antibiotics.

Janssen officials who spoke to RTV6 reporters said that the discontinuation was due to the availability of other alternatives for patients and a company focus on developing unmet patient needs.

According to the FDA, doctors should stop treatment with Levaquin, Avelox and similar drugs immediately if patients report experiencing central nervous system side effects, psychiatric adverse reactions, or blood glucose problems. They should switch those patients to a non-fluoroquinolone antibiotic if possible.

The agency also warned doctors to make their patients aware of the risks of low blood sugar when taking these drugs, and that psychiatric adverse reactions could occur after just one dose.

The FDA recommends that health care professionals be aware of the new warnings and the potential risk of hypoglycemia that can result in coma, which could occur more frequently in elderly patients or diabetics taking insulin or an oral hypoglycemic medication.

Fluoroquinolone Side Effects

Hundreds of Levaquin lawsuits,  Avelox lawsuits and Cipro lawsuits have been filed in recent years, each raising similar allegations that the drug makers failed to adequately investigate the safety of their drugs or warn about the disabling side effects. Plaintiffs maintain that they may have avoided long-term and permanent peripheral neuropathy problems if adequate warnings had been provided.

The widely used class of antibiotics has been on the market since the 1980s, including brand names like Levaquin, Cipro, Avelox, Factive, Baxdela, and more than 60 generic equivalents. The new warnings apply to those fluoroquinolones taken by mouth or by injection, and is the latest in a string of label updates required in recent years.

In August 2013, the FDA required the makers of all fluoroquinolones to provide stronger warnings about the peripheral neuropathy risk from the antibiotics, indicating nerve problems associated with the drugs may last for months or years after an individual stops taking the drug.

The FDA issued a major fluoroquinolone antibiotics warning in May 2016, due to a variety of “disabling and potentially serious side effects,” which led the agency to conclude that the risks may outweigh the benefits associated with using the medications to treat uncomplicated infections.

That warning concerned reports of permanent nerve damage, known as peripheral neuropathy, as well as tendon ruptures and other health risks.

Concerns about the risk of aortic dissection and aortic aneurysm with fluoroquinolones emerged in late 2015, following the publication of a report in the medical journal JAMA Internal Medicine, which found that current use of Levaquin, Avelox or other similar antibiotics was associated with a two-fold increased risk of suffering an aortic aneurysm or dissection injury.

 

16 Comments

  • WayneMay 12, 2022 at 10:00 am

    Levaquin almost killed me I was rushed to the hospital because I couldn't talk or breathe within less than five minutes after taking that poison. The cipro I took a year and a half before the Levaquin experience... ... my doctor had given me snapped my Achilles tendon right foot. I've been left with permanent neuropathy in my legs. Feels like my legs are on fire with needles it's miserable. [Show More]Levaquin almost killed me I was rushed to the hospital because I couldn't talk or breathe within less than five minutes after taking that poison. The cipro I took a year and a half before the Levaquin experience... ... my doctor had given me snapped my Achilles tendon right foot. I've been left with permanent neuropathy in my legs. Feels like my legs are on fire with needles it's miserable. All this is NOTHING COMPARED TO NOT BEING ABLE TO BREATHE WHICH THE LEVAQUIN DID TO ME. NOVEMBER 2014

  • RobertApril 3, 2022 at 7:43 pm

    Hands, fingers swelled, Doc said that was because of all the liquids they had given me. 1 year later my fingers are still acing. cannot make fist in hand cannot open a water bottle, my hands are still VERY tender. Nothing helps!

  • JanDecember 1, 2021 at 4:11 pm

    I took a 10 day course of levaquin for bronchitis. I was over 60 and on chronic prednisone (steroid) both are reasons NOT to prescribe this dangerous, life changing drug. Suddenly on the 10th day i went to ER with BP 190/140-could not catch my breath. For the first 2 months i could hardly walk, i had to hold my head up, and more. Now, 6 years later i am left with residual imbalance needing a c[Show More]I took a 10 day course of levaquin for bronchitis. I was over 60 and on chronic prednisone (steroid) both are reasons NOT to prescribe this dangerous, life changing drug. Suddenly on the 10th day i went to ER with BP 190/140-could not catch my breath. For the first 2 months i could hardly walk, i had to hold my head up, and more. Now, 6 years later i am left with residual imbalance needing a cane at all times and i lost memory of how to make my sea glass jewelry and how to paint. I have had to relearn it all but little has come back on its own.

  • PattyAugust 21, 2021 at 4:49 am

    Two years ago, my SIL went to doctor after having a heat stroke at work. During follow up visit, mentioned having back pain. Even though test were negative for a UTI, he was prescribed Levaquin. One dose sent him to ER at hospital. Severe side effects and tendonitis left him unable to walk more than a few feet. He has not been able to work for two years.

  • SusanJuly 31, 2021 at 7:18 pm

    I was diagnosed with the onset of pneumonia back in 2014. Just a small amount of fluid on my lungs for which I was prescribed Levequin. I took the dose for 7 days. On the 8th day I felt this very strange warmth travel down my back. Within a day or two I could barely lift my arms to turn the radio or any activity that required lifting and stretching my arms forward. I also developed irritable [Show More]I was diagnosed with the onset of pneumonia back in 2014. Just a small amount of fluid on my lungs for which I was prescribed Levequin. I took the dose for 7 days. On the 8th day I felt this very strange warmth travel down my back. Within a day or two I could barely lift my arms to turn the radio or any activity that required lifting and stretching my arms forward. I also developed irritable bowel syndrome D, oral planus lichen (mouth inflammation and sores) and atrial flutter. I researched the side effects at the time and some of the reading I did said that there was some theory that Levequin leached magnesium out of the tendons. I started taking magnesium supplements back then. The tendon symptoms somewhat subsided over the years but there are still times when certain movements of my arms will hurt. I have no idea of the validity of the magnesium issue but I guess it didn't harm anything. While my symptoms are not as dire as many others I have read about, I agree it should not be on the market, though a nurse told me recently that it was.

  • GlendaJuly 27, 2021 at 2:20 pm

    i had a 3 month course of what seemed like "frozen shoulder" shortly into my second of this drug given me for staph i picked up during a minor surgery. This was in 2008. I still do not have full range of motion in this arm. Then, I was told: coincidence, Levaquin doesn't do that. I knew better then and know better now. Not all drugs out there are safe for all people all the time. And with the [Show More]i had a 3 month course of what seemed like "frozen shoulder" shortly into my second of this drug given me for staph i picked up during a minor surgery. This was in 2008. I still do not have full range of motion in this arm. Then, I was told: coincidence, Levaquin doesn't do that. I knew better then and know better now. Not all drugs out there are safe for all people all the time. And with the numbers of dire complaints about this one, I agree. It Should be off market. Period.

  • SusalynJuly 26, 2021 at 7:04 am

    I was prescribed levaquin for a bacteria in my stomach on July 2021 first day of drinking ok the second day my body was acking like if someone beat me up my left arm was hurting but as I kept drinking the pill 3 days later I couldn’t move my right shoulder n my bones was hurting went to the er n that’s when the doctor told me that levaquin does that to ur body had to stop drinking the med had to s[Show More]I was prescribed levaquin for a bacteria in my stomach on July 2021 first day of drinking ok the second day my body was acking like if someone beat me up my left arm was hurting but as I kept drinking the pill 3 days later I couldn’t move my right shoulder n my bones was hurting went to the er n that’s when the doctor told me that levaquin does that to ur body had to stop drinking the med had to see an orthopedic doctor said I have acute pain of right shoulder tendinopathy of right rotator cuff and frozen shoulder and now I have to go for therapy for my shoulder because of the dam pill the pain is so painful n burning that at night my shoulder nerve jumps on it’s own they need to remove this pill ASAP or they will be more people with worse condition causing even death .

  • MarleneJuly 17, 2021 at 3:47 am

    I had a serious lung condition that wasn't improving on other antibiotics. My doctor prescribed Levaquin which I took for 4 or 5 days. I woke one morning and couldn't feel my feet. I called my doctor and she said not to take anymore. Since that time, I have suffered many of the same side effects described. I have gotten weaker in my legs, especially, so weak I can barely climb the stairs to m[Show More]I had a serious lung condition that wasn't improving on other antibiotics. My doctor prescribed Levaquin which I took for 4 or 5 days. I woke one morning and couldn't feel my feet. I called my doctor and she said not to take anymore. Since that time, I have suffered many of the same side effects described. I have gotten weaker in my legs, especially, so weak I can barely climb the stairs to my bedroom! My feet are painful to walk on and the muscles in my legs seem to have lost their strength. Sometimes the numbness and pain are so bad all my legs, including my hips feel numbness and pain. I am 87 and have been in general good health, but I had never been so sick with coughing until I couldn't breathe. The Levaquin did help that condition, but all this time I have been in declining health, with much pain in the muscles of my thighs, calves, and feet. I have tried corrective orthotics which had done nothing to make me feel better. I have been depressed, and sometimes feel that I am going to die soon. My doctor wants me to see a psychologist. I am a psychologist, and I know how to gauge depression and stress I work 2 days a week and even that is becoming too much for me to do. Some days are worse than others, but the side effects are still operating. I'm angry and sad, because most people have thought I am much younger than my 87 years, but now I look and move like a sick old lady. My children don't understand. They think I need to go into some rehab or physical therapy or should just keep moving more. I feel that soon I will not be able to go to my room upstairs at all. I can't do my housework as I always did until this happened to me. It's just too hard and painful. I have to continually to rest even after I barely exert myself. I have to pull myself up the stairs by my arms. If I didn't have adult children who help me as much as possible, I don't think I would try to keep living. There is no help for these conditions as a result of taking this medication. I thank everybody who has commented here, and I believe that Levaquin is a dangerous medication that nobody is talking about!

  • BarbaraMay 6, 2021 at 9:21 pm

    I was prescribed Levaquin last June, 2020 for a stubborn sinus infection. During taking it I felt lightheaded and weak and almost passed out after bending down. The room went dark and was spinning. I stopped taking it and haven't felt right since then. Still weak and shallow breathing. Then in March I had another bad weak spell and felt like I was going to faint while standing at the kitchen sink.[Show More]I was prescribed Levaquin last June, 2020 for a stubborn sinus infection. During taking it I felt lightheaded and weak and almost passed out after bending down. The room went dark and was spinning. I stopped taking it and haven't felt right since then. Still weak and shallow breathing. Then in March I had another bad weak spell and felt like I was going to faint while standing at the kitchen sink. I made an appointment with my family practice doctor. She did a blood test and ordered an echocardiogram. My red blood count was down to 10.2. The echocardiogram showed a slight "regurgitation in one valve. Tomorrow I am seeing a Hematologist. I am very upset.

  • EricFebruary 5, 2021 at 9:32 am

    In 2011 my wife owned a dance and gymnastics studio. She was extremely fit, strong, and healthy. She had a sinus infection and was prescribed Liviquin. The next 10 years of her life have been hell. Approximately 3 days after taking the drug she suffered a series of tonic seizures. Probably about 15 over a 2 month period. She had numerous tests at significant cost but no explanation was ever gi[Show More]In 2011 my wife owned a dance and gymnastics studio. She was extremely fit, strong, and healthy. She had a sinus infection and was prescribed Liviquin. The next 10 years of her life have been hell. Approximately 3 days after taking the drug she suffered a series of tonic seizures. Probably about 15 over a 2 month period. She had numerous tests at significant cost but no explanation was ever given. She was restricted from driving for a year which resulted in numerous issues with her business and the emotional trauma was incredible especially on her but our daughters too who witnessed these seizures, they were 8 and 10. She never had additional seizures. At the time we were told it was unlikely it was the leviquin. Although I was convinced it was! Shortly after this she started suffering countless tendon issues that have progressively gotten worse. She also began to suffer from numerous optic migraines which was blamed on a atrial septal aneurysm. This was found during all the tests that were performed to explain her seizures. She has had numerous surgeries on the tendons in both elbows. Her shoulders also have damage. We decided to close the dance studio due to all this despite that the business was doing ver well she just physically could not do it anymore. In 2014 we moved to gulf coast hoping warmer weather would help her. She did some teaching at local dance studios but her body continued to decline. We had a device installed in her heart to stabilize the aneurysm in 2017, I don’t think it’s helped. She’s seen numerous doctors that can’t explain all the damage to her body. She filed for disability in 2018 and it was granted in 2020. Her health continues to decline. She has lost all her muscle tone and is just a fragment of what she was 10 years ago. She is now 45, 5’ 10’ and110lbs and barely able to do anything. She struggles to put on weight and can’t create any muscle tone. She lives in constant pain and continues to see numerous doctors weekly for all her issues. My brother passed away in December 2020, a few weeks prior he told me of the Leviquin horrors and told me to look into it. I just started researching and have read so much of similar stories to my wife. Is it possible it is all related to that 3-4 day period in 2011 that she took it? I don’t know if she has a case here but something has to explain the decline in her health. Back before we closed the studio I use to say she should be the most fit and muscular person around because she worked out 6+ hours a day but it seamed the more she worked out the more muscle mass she lost. It never made sense but her decline all seamed to happen right around the time she was prescribed the Leviquin.

  • DeborahOctober 19, 2020 at 1:06 am

    I’ve been completely stopped by this drug as well. Reading all these comments let’s me know I’m not alone but also that there is no help for us either. I too have Achilles’ tendon tears, cannot pick thongs up because there is no integrity in my hands and they feel like they’re breaking. I have been in a fog and feeling like I cannot concentrate and feel dizzy most of the time. I lost my job in[Show More]I’ve been completely stopped by this drug as well. Reading all these comments let’s me know I’m not alone but also that there is no help for us either. I too have Achilles’ tendon tears, cannot pick thongs up because there is no integrity in my hands and they feel like they’re breaking. I have been in a fog and feeling like I cannot concentrate and feel dizzy most of the time. I lost my job in beginning of June because of COVID. I am not fit to work currently because of my physical and mental condition. I feel ruined! What can we do ?

  • AmandaSeptember 22, 2020 at 8:06 pm

    I was just prescribed this in April. I was rushed out of the hospital because Covid cases were coming in and they sent me home on this. i was on a different antibiotic in the hospital. I took ONE PILL on Tuesday morning and by Tuesday night i had lumps in my legs and i couldn't walk. Called my doc in the morning and she said do NOT take another pill and go to the ER right away. They said i was hav[Show More]I was just prescribed this in April. I was rushed out of the hospital because Covid cases were coming in and they sent me home on this. i was on a different antibiotic in the hospital. I took ONE PILL on Tuesday morning and by Tuesday night i had lumps in my legs and i couldn't walk. Called my doc in the morning and she said do NOT take another pill and go to the ER right away. They said i was having a reaction to the medicine and they sent me home on different meds. That was in April. It is now September and there are days i can hardly walk at all. I cannot stretch my legs or arms. I get burning sensations in my legs and arms. My toes and fingers get tingly and numb. my achilles tendons are so tight i am afraid i will rupture them. and i'm developing carpal tunnel. my job is typing. I have no strength at all in my right hand anymore. I have talked to my doc so many times and said all he can offer is muscle relaxers and physical therapy. surgery cannot be done until something very bad happens or ruptures. I have tried finding a lawyer, but they are being blocked apparently from being sued, so not sure i will ever have a case. I have been a single mother for 11 years. i am all she has. if i cannot work or move,how can i take care of my kid. she is already helping me do everyday tasks around the house since i cannot lift or move a lot. This is unacceptable! The medicine needs to be removed or be locked away for legit plague patients. i had sepsis brought on by some kind of e coli. the other antibiotics worked. I've never had real health issues before and feel i did not need something so strong and lethal. Now i have to suffer with this and it is impairing my everyday life. My nerves and tendons are ruined by this drug and there is nothing i can do about it.

  • MichelleAugust 10, 2020 at 6:52 pm

    I was prescribed this drug in July 2020 at the ER for mild pnemonia. I think I've suffered every one of the black box warnings except the heart stuff/death. There are other options that would have been safer to start with. I assumed the doctor knew best and went against my better judgement. Now I can't use my hands or feet (tendon issues). My eyes, skin and mouth are beyond dried out plus I h[Show More]I was prescribed this drug in July 2020 at the ER for mild pnemonia. I think I've suffered every one of the black box warnings except the heart stuff/death. There are other options that would have been safer to start with. I assumed the doctor knew best and went against my better judgement. Now I can't use my hands or feet (tendon issues). My eyes, skin and mouth are beyond dried out plus I have been moodier than ever before. I've been off for 2 weeks (took for 5 days) and don't see any improvement. In fact, some things are getting worse. I have a connective tissue disease that was in remission and doing so well up to this point. It should say, "If you have any kind of collagen or connective tissue disease, do NOT take this, it will totally f*** up your life!"

  • NicoleJune 29, 2020 at 11:52 pm

    Just left the ER June 29th 2020. Acute tendonopathy of the achilles and pulled muscles/tendons of the rt hip flexor and rectus abdominus. Prescribed Levofloxacin 3 times this year for mycoplasma ureaplasma. It has ruined my life and the mycoplasma is still eating me alive. Going to lose my union factory job over this. Severe pain ignorant Docs

  • OrfMay 25, 2020 at 9:24 pm

    The are still using this poison RX I was poisoned by it April 22 2020 and now can hardly walk- pick up a coffee cup etc. the makers of this drug and those who RX it are evil.

  • BobJanuary 22, 2020 at 6:01 am

    I was just ion the hospital tonight (1/21/20), and they STILL are using Levaquin - it is NOT off the market! I've had diverticulosis for 25+ years. For the first (2) years my Dr prescribed Cipro as a first-course med to combat it, then I was prescribed Levaquin - for the past 23+ YEARS! I have all kinds of side effects and am thinking that it's linked to other issues I've been having. I'm wonder[Show More]I was just ion the hospital tonight (1/21/20), and they STILL are using Levaquin - it is NOT off the market! I've had diverticulosis for 25+ years. For the first (2) years my Dr prescribed Cipro as a first-course med to combat it, then I was prescribed Levaquin - for the past 23+ YEARS! I have all kinds of side effects and am thinking that it's linked to other issues I've been having. I'm wondering if it has anything to do with Celiac's Disease (allergy to wheat, etc) caused by "pockets" within the intestine. There's a LOT more to this story .. and Levaquin is at the heart of my problems.

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