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Should Levaquin Carry Stronger Warnings?

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Los Angeles, CARecent concerns about Levaquin side effects have prompted some critics to call on the Food and Drug Administration (FDA) to take stronger action regarding Levaquin. A recent report by ABC10 News highlights some of the concerns medical professionals and patients have about the drug.

According to ABC10 News, some researchers are concerned that Levaquin has more serious side effects than those mentioned on the drug’s label. Specifically, they are concerned about depression, hallucinations and mitochondrial toxicity, which indicate the drug could actually have an effect on a patient’s cells. Studies have reportedly been undertaken at UC San Diego and University of Rochester to look into some of the side effects that could be linked to Levaquin.

Levaquin is an antibiotic in a class known as fluoroquinolones. Although they are lifesaving drugs, some experts believe they are overprescribed, putting many patients at risk for serious side effects. Further, in some cases, they are used for fairly minor infections that may not require a strong antibiotic, so the risks might outweigh the benefits. Levaquin currently carries a black box warning about the risk of tendon rupture.

The Southern Network on Adverse Reactions (SONAR) submitted a Citizen Petition (also found online at www.regulations.gov) to the FDA regarding Levaquin. In it, the organization requested a black box warning about the possible risk of mitochondrial toxicity, a label change to include the risk of “possible mitochondrial toxicity,” and the issuing of a “Dear Doctor” to inform physicians about the label changes.

The petition notes that from November 1, 1997 to February 3, 2011, the FDA Adverse Event Reporting System received reports of 79,328 reactions linked to Levaquin. Because the events reported to the FDA are estimated to be between one and 10 percent of actual events, SONAR estimates that the actual incidence of adverse events is between 793,280 and 7,932,800.

SONAR acknowledges that Levaquin may in some cases be the most appropriate medication, making some of the adverse events unavoidable. In other circumstances, however, if there had been Warnings, including a Black Box Warning, about the potential for Levaquin “Mitochondrial Toxicity,” some physicians may not have prescribed Levaquin for some patients.

Levaquin (known generically as levofloxin) is made by Johnson & Johnson.

A lawsuit has been filed against Johnson & Johnson alleging the company failed to warn about the risk of peripheral sensorimotor neuropathy. That lawsuit is Grossman v. Johnson & Johnson et al, Case No. 3:2014cv03557.

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READER COMMENTS

Posted by

on
I was given this drug levaquin back a couple of months ago and shortly thereafter pain started in my left knee, then to the right elbow, then to the left elbow and neck and finally both knees and elbows. Was admitted to the hospital for an eval and pain therapy. After coming off of the drug for a month or so I was able to move a little bit more but always with pain. Got put on levaquin two weeks ago due to having no white blood cell production caused by neutropenia, those pains are returning. going to see my primary care doctor and will ask the question, is this why I have been immobilized for the last 2 1/2 months, bet she don't have a clue.

Posted by

on
I was given Levaquin before oral surgery. I took one before bed and woke up in the middle of the night feeling suicidal and really depressed….it was a very scary out of control feeling. I called the doctor the next day. I got the feeling they thought I was making this up. Thank God I was switched to a different antibiotic.

Posted by

on
I took levaquin in 2006 and loss my baby...more problems followed heart problems..leg problems..blue toes numbness on my right side..then again in 2011 they gave me levequin again..for sinusitis .had a stroke now my face is twisted...and i have perferial nurapathy...and edema in both legs numbness in my right leg and im not over weight 145lbs and just turned 42...i dont eat meat...dont drink soda and dont eat out. My problems consists until now.

Posted by

on
First I want to give everyone an alternative to these deadly drugs & hope to save others from our fate. FOR ANY BACTERIA, & INFECTION, please try Colloidal Silver before allowing your health to be DESTROYED by incompetent doctors influenced by money grubbing pharmacutical companies that know the money they make from sales will be tenfold what they will pay in settlements years later when finally busted for their toxic products.

Doctors provide no warning whatsoever of the dangers of these drugs. I was given levaquin at the ER for lung infectiion and not one word of caution or warning instead told it was antibiotic for viral instead of bacterial infections. When I began experiencing side effects and tried to report to my doctor, I was accused of imaginary pain and drug seeking. I explained the numbing tingling pain that progress to sharp knife like stabbing in my hands and feet and right side of my lower back down my right leg. also accompanied by disorientation, confusion and dizziness; then red bumps like a rash then finally handfuls of hair started falling out. After reading the symptoms in serious adverse effects of this drug another ER visit and attempt to report these problems added to the difficulty accompanied by my disorientated state, resulted in ignoring and dismissing my concerns of complications being associated with the drug. That was 2 years ago and health, mental and physcial problems including heart problems have continued and increased while doctor visits where my association of these issues beginning after taking levaquin are dismissed.
My life is over. I can't do anything at 50 years old. I'm a prisoner to the pain from this drug & the incompetence of medical professionals who will not even acknowledge my declining health problems are all listed in the side effects and began shortly after taking this drug.
I wish i would have found the miracle infection fighting Colloidal Silver before my life was destroyed so I HOPE to get the word out of this LIFE SAVING Infection fighter and maybe save others from the death sentence handed out by doctors prescribing toxic deadly drugs like this and steroids that shut off your immune system. Just watching drug ads on tv an listening to the rapidly worded warnings of side effects from Cancer to DEATH, how can sane person even think of taking ANYTHING, advertised & wish all drugs were PUSHED in commercials where at least Side EFFECTS are required to be REVEALED.

Posted by

on
When I has a surgical site infection I was given IV Vancomycin in the hospital, then oral Levaquin for months. I have been given Levaquin routinely ever since then as the infection was caused by MRSA and the physicians found me to be a carrier. I live with horrible pain every day. My rotator cuff is damaged and has reduced range of motion. I have muscle pain and weakness, tendon problems, tinnitus and insomnia since that first infection14 years ago. It has destroyed my quality of life. I feel this drug should be a back up for MRO (multi-resistant organism) and never offered routinely. It should be seen the same as giving a unit of blood. Both potentially carry long term negative health implications!

Posted by

on
I was given Levaquin along with Prednisone when I had a cold that made my asthma flare up. There was no infection at all. This drug ruined my tendons and my ligaments throughout my body. I took only 4 pills. These drugs should be reserved for cases where the infection is life threatening. This has changed my quality of life so much. The doctors do not realize that this damage is permanent for many people.

Posted by

on
I have been very sick by other drugs in this classification and am very active in trying to stop the use unless the person is literally on their deathbed. The reason why they should be on their deathbed is because after one ingest this poison, even months,later as there are delayed reactions and drs don't believe you, you already feel as if you are on your deathbed.

Having said the above, yes black boxes are important but more important is getting the doctors to READ the black boxes and know the dangers of these drugs as their drug reps don't tell them and that is where doctors get their information from. Drug Reps!

Doctors also need to know that Levaquin is in the same class as Cipro and Avelox and Floxin but they don't seem to know this and give out one or the other if the patient mentions they are allergic to Levaquin or one of many others in the FQ group.

Also topicals such as ear and eye drops need to be included as these are just as dangerous and given out too frequently as well. Children are given the drops and that is a major problem because infants and toddlers can't articulate what is bothering them. Perhaps their learning abilities are being disrupted too. It is a known neuro toxin and affects the brain.

Older people are given eye drops for cataracts. If they start complaining about aches and pains, doctors say it's their age and not the drops they put in their eyes.

Fluoroquinolones are terrible dangerous drugs.

Posted by

on
I was given sample pills of Levaquin for a kidney stone issue. Then I was given 4 bags of Levaquin in the Hospital. My problems started right away with a torn meniscus, torn rotator cuff and several other joint problems. I had severe anxiety and was pretty much confined to my bed. I had surgery for the torn meniscus and it's been downhill from there. Now my knee is bone on bone, I have peripheral neuropathy, spinal stenosis, Spondylosis, tennis elbow. I no longer feel I have a life. I can't exercise which has caused me to gain weight, I can't go shopping like most people this time of year and its caused me to feel depressed because I can't do the things I use to be able to do. This medication should be saved for people who are dying!! It would of been nice to be told that Levaquin could cause all of this BEFORE it was given to me. It truly sucks.....

Posted by

on
ALL fluoroquinolone antibiotics, whatever route of administration carry EXACTLY the same risks.
Only they are not really antibiotics, they are instead extremely dangerous synthetic neurotoxic chemotherapeutic agents, there is nothing therapeutic about this chemo unfortunately, & chemotherapy is EXACTLY what they may as well be, as they are Topoisomerase inhibitors, if you look this up you will find the other drugs with this mechanism of action are in fact Chemotherapy, Why oh WHY !, are we being prescribed an atomic bomb for a simple UTI , or even as in my case without ANY infection even being present ? It is unreal !. They can only EVER be justified for use as a last resort when all others have been tried , have failed & the only alternative left is your death!.

I have now lost 26 years of my life to this, & I have to explain to my severely disabled grandson why nanny cannot play with him, he just does not understand, & it breaks my heart…
I am now permanently damaged , both cognitively & physically, I feel like I am 90 years old, I am melting inside, my connective tissues disintegrating day by day.
The original Quinolones were deadly enough , but the fluoroquinolones come straight from the depths of hell, believe me
Unfortunately as is the case for far too many people, they can then drag you straight back down there with them , & then leave you there, in excruciating pain which truly is not of this world …... all too often for the rest of your life !!.

Posted by

on
It has been a year for me now since taking Levaquin and I am still experiencing muscle pain and weakness, tendon problems, tinnitus and insomnia. I spend every day in pain now, and doctors have no answers on how to help me. Forget the black box warning. This drug needs to be taken off the market!

Posted by

on
Avelox which is the kissing cousin to Leviquin, is also a very scary drug. It is also a Quinqlon drug like Leviquin but also comes with no warning that it can be lethal. Bobby, a 78 year old very healthy male, was diagnosed with diverticulitis, hospitalized for for two days, given Cipro and Flagil IV and discharged with no further symptoms. With no warning what-so ever he was given a script for Avelox, to be taken for 7 days as follow up med. With a call to two different pharmacists, again receiving no warnings, he took it and began to become very ill. Later I learned that it was a drug of last resort and the pharmacists never dispensed it ie they knew llittle about it other than the class of drug. He began Feverof of 103 and the after several house when the fever broke, a temp of 94, tremors, extreme weakness, unable to consume any food without gagging, extremely low B/P, 30 pound weight loss in one month. When questioning the prescribing personal physican he was never told to d/c the drug. He was hospitalized, under the care of infectious disease specialists, who tested him for everything under the sun for 17 days and and he was discharged with no diagnosis. He was at home in a wheelchair forr 5 days and trqansported to Duke University Hospital and discharged again with no conclusive diagnosis, but tests pending. Three days later, duke called and said get a Rheumatologist ASAP. His numbers for Lupus and RA were off the chart. He has been treated for over a year for Lupus and now, also diabitis. He now takes 22 pills a day and has good days and bad days but is half the person he was. Many days he needs to sleeps 15 or more hours a day.
Avelox is given as a drug of last resort primarily for resistent lung infections and should never have been prescribed for a sucessfully treated bowel problem. About a week into the 17 day hospitalization, I went to Wal Mart and the pharmiscist gave me what she called their "gold list" from her computer. It is a about a five page document describing the adverse effects of Avelox.
In that list, it documents Bobby's symptoms. His immune system has been severly, adversly affected. He now must take Cellcept, 3000 mg. per day, which is the maximum dose and which is usually given to transplant patients to supress the immune system. It is a very serious drug and has many side effects.
This whole situation has been a nightmare which is far from being over.

Posted by

on
I've been suffering from reactions to Cipro for a little over a year now. My long list of problems include stomach, nerve, burning/tingling skin, anxiety, horrible tinnitus, depression, TMJ, pain in joints, vision flashing/and floaters, extreme headaches and the latest are my Achilles tendons in both ankles. Fortunately they have not ruptured yet, but I have insertional tendonitis an chronic tendonosis. I've been to countless specialists and no one could give me answers. A few mentioned it could be from the Cipro but could not prove it. The only doctor that actually agreed to it was my podiatrist which is now treating my Achilles tendon problems. He says the way my problems are presenting are classic flourquinlone induced problems that he has treating around 15 times over the last few years. What really stinks about this whole experience is I ended up finding out that I never had an infection and did not need the cipro anways. After the first dosage I started experiencing problems and notified my doctor but he said it would all pass and I should keep taking it. Needless to say I never returned to that doctor. It was only weeks after stopping on the 11th day of Cipro that I started to piece all together. I talked to about 6 different pharmacist as I was trying to piece this all together and not even one of them knew about the warnings on this drug. They kept wanting to explain the Half Life of the drug and how there is no way it could be causing my delayed reactions as it should have already left my system. About 2 months went by with me doing my own research only to return to these pharmacist to show them I found the black box warnings on this drug and they said oh I didn't know it had one. In all the steps you have to go through to get these drugs from doctor, insurance, to pharmacy someone needs to be responsible enough to warn the patients about the risks. I was given 3 dosages of cipro after a bladder scope with no paper work or warning at all. This was 2 days before I was actually prescribed the 30 days of cipro. My hope is that I am able to cope with the problems and they stop presenting new ones. Of all of the problems I am currently experiencing only two of them are slowing me down in life. The tendon problems and the tinnitus. I never knew I could actually feel sound, but that is what it is like. Loud sounds come through and amplify the buzzing in my ears causing me to feel pain in my head. When my daughters talk loud I have to go to another room as I can not stand the reaction.

As a previous poster commented. I can not get legal representation because I, 1: Took the generic and 2: took it after the black box warnings were issued, so it was at my own risk is what I was told.

Posted by

on
I question how effective the black box warnings are that are already in effect. People continue to be damaged, many permanently, by the thousands.
Why? because pharmacists continue to fill prescriptions with out a word of caution. Doctors give this drug our like candy without telling people that it carries a black box warning. When patients come in with the very adverse effect in the product inserts, they are told it is not the drug and thrown into a receptacle of fibromyalgia, arthritis or depression. This system is broken.
We need more than more warnings. We need doctors to respect this drug as it was intended, a last resort treatment. We need doctors and pharmacists to read the warnings and side effects to the patient so they will both be aware of the dangers when they present themselves.
Above all, disclose to the patient that this drug works by disrupting the DNA/RNA replication of the bacteria, it does the same to the mitochondrial DNA of the host, you and me. A horrifying thought.
I might add that my own mitochondria was so damaged I was only producing 6% mitochondria energy at 4 years out. I took a total of two pills. Think about it and protect yourselves and loved ones.

Posted by

on
Absolutely, all FQs should carry stronger warnings!

They are damaging and killing people all over the world; better yet, if they can't regulate it, then they should all be pulled from the market as it is evident, especially since 2011 that they are doing more harm then good.

Sadly, the Fluoroquinolones are given out like Candy since 2021 for such minor ailments as sinus infection, colds, urinary tract infects. Myself, i was given these worse then chemotheraputic drugs ... 10 pills for 10days for a suspected UTI infection and Stones, which i told my doctor that my upper middleinner burning pain was from Clindamycin (another dangerous drug). She laughed at me and said there are no anbiotics that do such harm. I refused further antibiotics for 7 months, them i gave in as the the burning pain that felt like my organis were on fire ... Sizzling, burning ceased to stop. Then my doctor prescribed me Cipro XL within 2 hrs my first adverse reaction, then that night, then that week, and new serious adverse reactions continued. And again my doctor laughed at me and said it is genetics, then some other storey. She refused me to recommend me to any doctor's nor do any xrays, MRI.

Posted by

on
My life was ruined by Levaquin.....

Posted by

on
Levaqui cause my rotator cuff to ruture. I endured major surgery and PT following. I contacted an attorney who got all my records etc...then informed me that only the "Real" Levaquin manufactured by Johnson and Johnson (which only the very wealthy can afford) not the "generic" which I recived. Therefore the generics which they claim are the same drug, cannot be held responsible by their manufacturers. Is this a way for them to weed out the ones who cant afford the actual "real" drugs? I am still enduring pain and no one is being held accountable.

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