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FDA Announces Levaquin Risks Outweigh Benefits

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Washington, DCThe FDA today issued a new warning for Levaquin and other fluoroquinolones, adding that side effects of the antibiotic medication “generally” outweigh its benefits.

The FDA warning came almost a year after an investigation by NewsNet5. Its 5 On Your Side program reported that an FDA database comprised “at least 3,000 patients whose death had been linked to the drug and another 200,000 complaints of side effects including kidney infections and nerve damage.”

Johnson & Johnson, the Levaquin maker, is also facing a federal racketeering lawsuit. While some pundits and attorneys might consider this claim frivolous and politically motivated, attorney Shezad Malik says that J&J is facing more serious claims. “Up to 500 Levaquin lawsuits have been filed in the federal court system claiming severe nerve damage,” says Malik. “These cases are MDL’d [part of the multidistrict litigation] for pre-trial discovery.”

While the FDA warning came too late for many consumers, Malik adds that Johnson & Johnson failed to warn consumers of such risks. The agency says side effects can include damage to tendons, muscles, joints, nerves and the central nervous system, and it continues “to find an association between fluoroquinolone antibiotic use and disabling peripheral neuropathy,” according to the Wall Street Journal (May 12).

The WSJ reported that the FDA’s decision “comes after a study of the issue by the FDA’s Office of Surveillance and Epidemiology, which concluded as early as 2013.” At that time the agency did issue a public warning but didn’t go so far as to slap a boxed warning on the fluoroquinolones.

In its defense, Johnson & Johnson stated that Levaquin has been on the market for more than 20 years, and more than 36 million prescriptions for fluoroquinolones were written in 2014 alone. But both attorneys and Public Citizen, the non-profit consumer rights advocacy group, show that tendon disorders - mainly from Levaquin - were first reported in 1997. By 2005, about 800 cases had been reported by Public Citizen.

Meanwhile, Dr. Malik - who is also a cardiologist - is investigating the risk of aortic aneurism. “In October 2015, JAMA [The Journal of the American Medical Assocation] released a study showing that the fluoroquinolones can cause damage to the aorta by dissection, or tears, and aneurysms, or enlargement. Both conditions can be fatal.”

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READER COMMENTS

Posted by

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I am a 70 year old male who had a fairly active life style. After going through five knee surgeries on my left knee, I had an infection in my knee replacement, and was recovering well from the final surgery. Working out, walking, working in the pool with my best friend and making great progress. Then I got a cold and went to see my doctor. Thought I had pneumonia and prescribed, you guessed it, LEVAQUIN!!!!!!!!!! I took 3 doses and was walking out of the VA Medical Center in Milwaukee, WI, when I thought someone kicked me in the ankle. I looked around and there was no one near me. I took three steps and was in excruciating pain. Turned around and went in and was told I had blown out my achilles tendon. Went home in a boot. Three days later I blew out the other achilles tendon. Since then, two plus years, I have not been able to stand up with out rocking back and forth. I am very unstable and fall down often, even with a walker or cane. My life, including my sex life, is over as I knew it. Once again as everyone has said, SOMETHING HAS TO BE DONE TO STOP THIS FROM GOING ON AND THIS COMPANY CONTINUES TO COLLECT BILLIONS!!!

Posted by

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In 2013 I was diagnosed with helobacterial pylori in the intestines and was prescribed Cipro which several days later resulted in intense pins and needles in my feet and hands. About a month later I had a strange vibration occur in the brain area on the back of the head and thought I had a seizure but because the weather was bad, I wrote it off to perhaps some barometric pressure or something. Following that episode my left foot would turn beat red and swell up like a balloon. The right foot would just hurt to walk on so I really didn't know what was going on. Went to the doctors and he prescribed me Hydroclorothiazide for inflammation. Then I got A sonogram of my whole leg to check for blockages and nothing resulted from that. My hands tingle, fall asleep and I drop things and it gets worse as time goes on. Both feet constantly vibrate and sting in pain especially when laying down for bed; it is the worst. I was a very healthy, active 42 year old that fell apart over night. Now I'm just a statistic in a big pharma ginnea pig nightmare. Now, upon recently hearing about this, during the last year or so talking with my sister and her ailing issues as well that we relate too, we actually thought this was something hereditary. Her symptoms are far greater than mine. She is literally disabled from her repeated history of intravenous Levaquin and hand written prescriptions over the course of 7 years. We are devastated upon hearing that our symptoms relate to so many of you all. We both have all the documentation relating and not once did any doctor say that those prescriptions may have played a factor. Even after symptoms or side effects unknowingly contributed toward the levaquin which was prescribed for other reasons. This is insane!

Posted by

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I was given Levaquin 750 mg. (even though I only weigh under 100#) for pneumonia. Since taking Levaquin I have had constant sore muscles, bad indigestion, bowel pain, have had my thyroid removed (Grave's disease), have trouble walking with a steady gait, depression, weird rushes in my head.

Before this I was a physically active, strong person, and rode horses. I have had to give up the horses because I'm usually too weak to take care of them.

Levaquin has changed my life from a happy active one to a struggle every day to keep going for one physical reason or another. I have cramps in my legs and feet and become very depressed for no reason.

My life will probably never be active and happy again.

Marilyn Warren

Posted by

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I was a HEALTHY GYM RAT and ate HEALTHY to make sure my husband and I stayed in great shape which we did for close to 20 years. Faithfully went to the gym 5 to 6 days a week. This really kept us young prolonging oxidative stress to our bodies keeping us fairly younger tha n our counterparts.
BUT AS OF MARCH 2012 MY LIFE/OUR LIVES HAS ENDED AS WE KNEW IT.

I developed a mild case of pneumonia which felt worse than the worst flu ever. Went to a GPS that was my mother-in-law's Dr. and not mine. I had an x-ray and in the end was given Levaquin, 500mg twice daily. By day 2 of medication I started with mild symptoms but a ringing in ear I never had before. 3rd day I had every SEVERE ADVERSE REACTIONS such as hallucinations, psychosis, not being able to think and form sentences. I freaked the ringing was in my head too not just in my ears. I stopped the medication called the doctor and he told me to take a lozenges. Can you believe that? Not one time did he say go to the ER. He never explained to me in the beginning what I was about to be up against. The PHARMACIST at Walmart FAILED TO CONSULT ME AND TO AT LEAST TELL ME POSSIBLE DANGERS.....NOTHING!!

Within a few weeks the tinnitus or ringing in the ear which most people get, mine started, my in my head too. You have to experience it to know. I cried nonstop for days and one Sunday my husband and son were on the sofa as I. I suddenly lost it, ran to the kitchen and cut both of my wrists cause I wanted to die it was so intense. Thank God my husband grabbed the knife but both sides were cut. Wasn't deep thank God.

Fast forward and I was suffering with severe pain in my left ankle. For months until I got an MRI. Found out I had a muscle tear. That tear snowballed into severe nerve damage. So now I've had 7 surgeries below left knee all the way down to foot. Nerves have been severed and killed. Nerve pain has been off the charts. Pain management doctors can't believe you are in this much possible pain. My 7th surgery was 2 months ago. Shoulder surgery, that was #8. Carpal tunnel syndrome severe in both hands. Occipital neuralgia of the nerves on my head. I'm now extreme depression and think about suicide all the time. I have a 17 year old that I had to go thru in-vitro to have him. That's how much he was wanted and loved. Now he's seeing his mom not being able to walk and my muscles, joints and tendons feel like they are in a vice grip.

I've been to every specialist under the sun and the same story of not believing this medication can cause this damage. Doctors please stop letting effing kickbacks and stupidity that you know nothing of the severity of permanent damage the medication causes. You have to know, it's been exposed and the FDA knows. I attempted to hang myself but my son is what keeps me fighting.

My life is over as I knew it. I will suffer with the debilitating nerve damage, body wide pain. I feel like someone beat me with a 2x4. No one deserves to live out their young remainder of their lives like this. Doctor failed me, pharmacist failed me and all the doctors that I brought this to their attention that suddenly develop a less than grade school education when acting they have no clue or still don't believe Levaquin does this OR THEY WILL HAVE TO ADMIT THEY WERE PART OF THE EQUATION OF DAMAGING LIVES.

THIS IS MY HORRIBLE LIFE STORY THAT I AM LEFT TO TRY AND CARRY ON WITH. ONE LAST THING, IF YOU TOOK A GENERIC YOU HAVE NO RECOURSE OF GOING AFTER THEM OR ANY GENERIC DRUG.

Please take name brand medication if it is the first time taking it. Spare yourself the heartache. I'M sorry for the long story buy felt you guys need to know there are others like us that are in bad shape.

Posted by

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I too have been prescribed both Levaquin, both in IV and oral form for bronchitis and kidney infections. I was never advised on the black box warnings ever. I have had really bad side effects even today including increased joint/muscle pain (I am current sufferer of Anklylosing Spondilitis) increased anxiety and just overall tired feeling and some confusion. I am just so angry that I wasn't better educated on this awful medication.

Posted by

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I was given this drug after a knee surgery by the VA became infected in 2008. Severe tendonitis in left leg since then and torn left Patellar Tendon. Go figure. Like to know.

Posted by

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In search for answers in to what has happened to me. Fluoroquinolones seems to be the only explanation that makes any sense at all. I have many tendon issues, aneixty attacks, neuropathy, complete muscle loss, advanced aging skin. The list goes on. I received a phone call today from a genetic specialist. I had mtDna done on myself and my parents to rule out anything genetic. This test did rule out genetic causes. I have two gene changes that affect my intellectual ability and muscle. So I can state something has happened and with all the other issues it points directly at Fluoroquinolones, there is no genetic markers that could have caused this. This has been a life altering situation for me. I have seen so many medical providers that simply pushed it aside and have ignored my pleas for help. I am appalled at the system in place as it is today. I have been handed so many anti-depressants and simply been told I was depressed. Me not accepting these diagnoses I pushed further with Physcians for it to only become really expensive and degrading. I have lost everything I was and am, and still no one cares. Not many Medical professionals will take the time to know their patients, so I ask this question. How can you treat someone you know absolutely nothing about. These Doctors are simply looking at charts. I can assure you they are not read and understood completely and are full of medical errors that a patient is simply not aware of. I pulled a lot of my medical records. Shock was a understatement. this is a mistake I will not make again. I went to the Dr screaming and begging with side effects of these drugs, I never in my wildest dream had a clue that a Antibiotic could do this to me. So I went ignored for years. Even after I figured it out. I was ignored. To me this is a disgrace to the profession. Had I had the attention of my medical providers, had they even looked for a cause, some of my damage may have been prevented. I took Levaquin in 2008 and 2009 and to further that along I took Cipro in 2012. This is something that needs attention yesterday, not tomorrow. And even after the FDA announcement I would be willing to bet that these drugs will still be handed out like candy.

Posted by

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It has been a year and a few months since I took Levaquin. My life as I knew it is over. I am in constant pain with my arms and right ankle. the feeling of anxiety and just overall not feeling well. I never knew about the black box warning on this and was not advised. I have been telling everyone what happened to me every change I get. Sometimes I just can not walk to move. I only took 8 pills and from the 8th pill i could not move my arms for over 4 months. so sad what they are doing to people.

Posted by

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I totally agree with Linda. Cipro is the enemy. I was first given Cipro in May of 2011. I was given it because I had a high white cell count. Since then my life has been a living hell. It started with projectile vomiting and diarrhea. It gave me a hiatal hernia. Later that year, I broke my ankle. The surgeon said my cartilage was like a wet paper bag. They ended up having to take out 2 inches of dead bone. I was in a wheelchair for years. After a few surgeries I am able to walk with a cane. In 2013 I was hospitalized. I made sure my chart said I was allergic to Cipro. Without my knowledge I was given Cipro again. For 10 days I laid there knowing I was dying. I overheard the doctor say Cipro!! OMG Take me off of it. I slowly got better. Since then I have met several people suffering the affects of Cipro. Terrible stories!!

Posted by

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I took Levaquin for pneumonia not knowing the potential side effects. Since that time I have been suffering with joint pain, tendonitis. After complaining to the doctor about the drug, I was given something else. I still have the bottle and some of the Levaquin.

Posted by

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I have torn four different tendons and also suffer from peripheral neuropathy. I now take numerous medications to help with the nerve pain. I have missed a lot of work because of this. I used to be very active but now spend a lot of my time resting because of the fatigue.

Posted by

on
I am suffering with multiple adverse reaction to this poison, But A more deeper investigation of this medication the manufacture and the FDA need to be done. There has medical research done with this class of drugs and its effect on the mitochondrial cell proving that the drug does mutate, damage and even kill off the mitochondrial DNA cell. The way this drug works is by mutating the DNA cells of the bacteria so it can not reproduce so it dies off, Our mitochondrial DNA cells looks exactly the same as that of the bacteria DNA cells and the drug can not tell the difference,, In the past the FDA has taken off the market similar medication for its bad effects on the mitochondrial DNA cell, But Every time its bean brought to the FDA to add to the black box warning that these drugs causes possible damage to the mitochondrial The FDA has voted it down the adds something like they just did to make us feel like we have one a victory, What I would like to see done is that this be added to the warning, I would also like to see that every prescription for this medication come with an informed consent for use of this medication stating all of its possible adverse effects that both the Doctor and the patient sign. This way both the Doctor and patient are fully aware.

Posted by

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I have been sick for over 21 years from various forms and names of Fluoroquinolones. The latest in 2013 the topicals which are NOT included in the FDA warnings but very well should be. My dad died of an aortic aneurysm 6 weeks after taking levaquin IV 4 years ago and Dr. Malik should indeed do more research on this newest finding. Doctors will still in my opinion give them out recklessly.

Posted by

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Since January 2015 Cipro has been the enemy. I was "floxed" and my life has spiralled down ever since with numerous problems including tendonitis, neuropathy and even broken teeth. I would not have believed that one drug could cause such a multitude of ailments but I am not alone and I truly hope the use will be reigned in so others do not suffer.

Posted by

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I took Levaquin three or four times for pneumonia. I never knew the potential side effects. Since that time I have developed consistent pain in my legs, arms, and back. There seems to be no medical reason for it. I do not know if Levaquin is responsible, but I would like to find out.

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