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Reports Of Tendon Ruptures Caused By Antibiotics Levaquin, Cipro, And Avelox

Public Citizen Files Lawsuit Against FDA Seeking "Black Box" Warning About This Painful And Lingering Side Effect

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  For recent developments regarding personal injury lawsuits that involve Levaquin and tendon-related side effects, visit the Levaquin Information page over at our Drug Injury Law web site.   (7/30/09)

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According to a January 3, 2008 Reuters article, "Group sues U.S. in push for new antibiotic warning", the consumer group Public Citizen has filed a lawsuit intended to force the FDA to consider whether stronger warnings should be added to certain antibiotics such as Johnson & Johnson's Levaquin as well as Bayer AG's Cipro and Avelox. This Public Citizen lawsuit was filed in federal court, specifically the U.S. District Court for the District of Columbia.

In August 2006 Public Citizen petitioned the FDA to add a "black box" warning to alert doctors and patients about the risk of tendon injury and rupture associated with Levaquin, Cipro, and Avelox, as well as generic antibiotics sold under the name ciprofloxacin — all being in the fluoroquinolones class of drugs.

According to the January 3 Reuters article about the new Public Citizen lawsuit:

The possibility of tendon rupture is now mentioned in the drug's prescribing instructions, but the warning "is buried in a long list of possible adverse reactions and is far too easy to miss," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group….

"While the FDA sits idly by and ignores the problem, more people will suffer serious tendon ruptures that could have been prevented," Wolfe said.

The FDA has received 336 reports of tendon rupture in patients treated with fluoroquinolones from November 1997 through March 2007, Public Citizen said. The actual number is likely higher because only a fraction of potential side effects are typically reported to the agency.

Levaquin, Cipro, and Avelox, as well as similar generic antibiotics, are widely prescribed in the U.S. and elsewhere for gastrointestinal, respiratory, and urinary tract infections.

P.S.  On July 8, 2008 the FDA announced that a so-called "black-box" Warning would be added to the package insert, or label, to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture associated with the following fluoroquinolones:

Ciprofloxacin (marketed as Cipro and generic ciprofloxacin)
Ciprofloxacin extended release (marketed as Cipro XR and Proquin XR)
Gemifloxacin (marketed as Factive)
Levofloxacin (marketed as Levaquin)
Moxifloxacin (marketed as Avelox)
Norfloxacin (marketed as Noroxin)
Ofloxacin (marketed as Floxin and generic ofloxacin)

For more details, see the July 8 press release, "FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs".  (7/9/08)

31 responses to “Reports Of Tendon Ruptures Caused By Antibiotics Levaquin, Cipro, And Avelox”

  1. Dominick Gagliardi Avatar
    Dominick Gagliardi

    In June of 2006 I suffered Kidney problems and was treated with Levaquin. My back and legs got so bad that I cound not lay in a bed for more than 6 months. With all the pain I had, I was sent for many Xrays. The doctor kept saying it was Arthritis. It took over a year for me to feel somewhat human again.

    Reply
  2. shane Avatar
    shane

    I had 4 courses of oral, 500mg. Levaquin for sinus infections from 2003 to 2006 and am now left with the debilitating effects of this drug, which has ruined my life. I am 45 and was actively fit.
    I now feel like a 90 year old. I have severe tendonitis in most of my body, but espescially arms, hands, legs and feet.
    I have tried so many drugs and therapies and nothing has helped.
    Warn your friends about this drug !!!!
    Shane

    Reply
  3. Tom Lamb Avatar
    Tom Lamb

    I appreciate you taking the time to share your unfortunate experience with Levaquin.
    Best of luck to you going forward.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  4. Joachim Svare Avatar
    Joachim Svare

    Something has to be done!!!
    I was treated with Avelox (for 17 days) due to a sinus infection in January 2008.
    The sinus problem went away and the day after I stopped taking the antibiotics my Achilles ruptured.
    My orthopedic doctor has no doubt that it was caused by Avelox !
    I’m now left with stacks of medical bills and a leg that will never be the same.
    Can anyone recommend an attorney who will take a case like this so I at least can get some compensation for my medical bills. I live in L.A.

    Reply
  5. Darlene Avatar
    Darlene

    I am experiencing the same thing. I’ve gone to the doctor a couple times already after a round of avelox, then levaquin, then cipro. I went to the doctor today to get a corisone shot in my knee and while I was there, I told him I thought I had a rotator cuff tear so he sent me for an x-ray on it, also. I told him the bottoms of my feet hurt. The side of my foot has hurt and the tendon in my thumb and forefinger has hurt. I had a double hernia last year. I bet that was from Cipro, also. It has been the antibiotic that I have taken for a long time when I have sinus or other infections. I too feel 90 years old. It’s such a shame. I wish I had known. I never would have taken the stuff.

    Reply
  6. Deborah Smith Avatar
    Deborah Smith

    I was given Avelox for treatment of pneumonia. As soon as I stopped taking it I started having severe pain in the bottom of my right foot, mostly in the heel and side of foot. After 2 follow up visits to my doctor and a visit to my foot doctor I was told it is plantar faciatis and heel spur. I have purchased over the counter orthotics and expensive shoes to try to fix it but it is still there. I go back next week to the foot doctor and he will likely tell me I need prescription orthotics which are very expensive and not covered by my insurance, OR WORSE, possible surgery to repair it. Now after reading that it could be caused by a medication that was prescribed by my doctor I am starting to wonder if it is even save to trust the medical profession again. Something is very wrong when the medication we take to fix one problem only causes more problems.

    Reply
  7. Tom Lamb Avatar
    Tom Lamb

    I understand why you are frustrated and doubtful, but most prescription medications are beneficial. Unfortunately, some unsafe drugs are on the market which doctors and patients need to beware of until if and when any such drug might be removed from the market because the serious side effect risks of that drug outweigh its benefits.
    I hope your medical condition improves.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  8. Rob Avatar
    Rob

    I recently took 750mg of Levaquin, 13 days, once daily, for a sinus infection. It was great for my sinus infection, but I now have tendon pain in both arms and came close to rupturing my Achilles on day 13 of the medicine. Coincidentally, on day 13, I attended a Levaquin presentation with my wife (a medical provider). No side effects were mentioned in the presentation but the Levaquin literature was distributed to the attendees with the mention of tendon ruptures buried in the handout. My wife read the pamphlet and quickly realized why I have been in pain since day two of taking the medication. Today is day 4 sans Levaquin and the pain has not waned. Can anybody tell me how long I need to stop physical activity without worrying about injuring myself any further? I am a former Special Forces Officer and I typically exercise four or five times a week so this is already killing me!!!

    Reply
  9. Connie Avatar
    Connie

    In 1998, my husband took Cipro 500mg. Around a month after taking it he started having rheumatoid arthritis type pain. We didn’t know it was connected to the medicine. 11 months after taking it he had his first rupture. He had 2 more after that. There were no ruptures for several years. In 2004, he took CiproXR. Around 11 months later the ruptures began again. He had 3 more ruptures after taking that. It would take too much time to write down all the ADR’s he has after taking these medicines. He’s disabled now. The benefits didn’t outweigh the risks for him.

    Reply
  10. Tom Lamb Avatar
    Tom Lamb

    Rob,
    As I am not a doctor, I cannot help you with the medical question regarding your condition.
    As you probably are aware by now, the tendon side effects are the subject of recent increased warnings for this antibiotic and others in its class.
    I hope you recover soon, and can get back to your normal level of activity.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  11. Tom Lamb Avatar
    Tom Lamb

    Connie,
    To the extent that your husband’s doctor(s) think the tendon problems are associated with his Cipro use, you may want to report your husband’s experience with this antibiotic to the FDA.
    Here are links to some pages at our web site, Drug Injury Law, which will tell you about the FDA’s MedWatch program and how to submit a report:
    http://www.druginjurylaw.com/drug-injury-reporting.html
    http://www.druginjurylaw.com/medwatch-report.html
    We wish your husband and you the best going forward.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  12. Greg Torre Avatar
    Greg Torre

    I was taking Cipro for a post-operative infection in my left leg while I was getting Supartz injections into my right knee to strengthen it (since the left leg was inpaired), the tendon on the medial front of my right knee ruptured and now I must use a brace on the knee and have chronic pain.

    Reply
  13. Tom Lamb Avatar
    Tom Lamb

    Greg:
    I appreciate you sharing your apparent Cipro side effect with us so that others know what to beware of if they use this antibiotic.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  14. Benton Avatar
    Benton

    Well no post have been here for a while. I took Levaquin about 2 years ago and had an awful time afterwards. No one ever told me what it was but I knew it was the medication. Haven’t been on any antibodic since until this week and had a bladder infection for which if was given macrobid. Never took it before but I now after finishing today have put together the severe pain in my feet is caused from this. I don’t know how long this will take to go away again but I can guarantee you I want be taking antibodics unless it is a matter of life and death. Someone said in the previous messages that it is bad how correction of on problems only leads to a worse problems.

    Reply
  15. Tom Lamb Avatar
    Tom Lamb

    Benton:
    Thanks for letting us know about your problems when using Levaquin.
    I hope you recover well, and that you continue to read Drug Injury Watch.
    Tom Lamb

    Reply
  16. Erick Owens Avatar
    Erick Owens

    On October 9th, 2008 I was prescribed Ciprofloxacin 750mg for an Upper Respitory Infection. I felt and heard a pop in my left ankle area on October 15th. My Family doctor diagnosed a ruptured achilles tendon and sent me to a specialist who stated it was actually a ruptured Grastrocnemius muscle. I am now in a hard cast. Why in 2008, is this drug still on the market. I did not see any info about this type of side affect. Which means if it was there…it needs to be in bolder writing. It’s bad enough I suffer from Lymphedema in both feet, ankles, and legs due to Colon Cancer surgery. Now I have to add this to my misery.

    Reply
  17. Tom Lamb Avatar
    Tom Lamb

    Erick:
    I am sorry to hear about your Cipro side effect. I hope you recover fully and quickly.
    There are some law firms handling this type of drug injury case. Let me know if you need assistance finding an attorney should you be interested in possibly getting legal compensation.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  18. Cammie Avatar
    Cammie

    Dear Tom,
    Wonder if you’ve seen any reports relating fluoroquinolone use to hypervascularization or venous perfusion into scar tissue? I’ve looked through available medical literature but have not seen this.
    I recently discontinued Avelox after 12 weeks (yes, “weeks” – long story).
    I was taking the Avelox due to infected surgical sites and hardware infection after a bad/open ankle break. Now, in addition to Achilles tendonitis, over the last 7 weeks I’ve had 3 separate episodes of swelling and inflammation along and surrounding the surgical scars, followed in a few days by what appears to be a varicose vein running just under the skin along the scar, which after a few more days opens and drains.
    The docs continue to treat these episodes as recurrent infection, which I suppose is relatively harmless (now using TCN-family drug) but these are really quite dissimilar to the original infection.
    I was just thinking that if hypervascularization of scar tissue could indeed be caused by fluoroquinolones, could venous perfusion into tendon tissue be one of the mechanisms for the tendonitis?
    Thanks in advance if you could point me to any reports such as mentioned above. (And sorry for the long-winded post either way!)

    Reply
  19. Tom Lamb Avatar
    Tom Lamb

    Cammie:
    To start, as I am only an attorney and not a doctor, I cannot give you a medical opinion.
    Of course, your doctor(s) would be a good source of information concerning this possible side effect.
    Another source of information is a web site dedicated to Avelox and the various other antibiotics known collectively as fluoroquinolones:
    http://www.fqresearch.org/
    Please let us know if you learn there was any connection.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  20. Angie Cowan Avatar
    Angie Cowan

    I was prescribed Levaquin in October 2007 for a sinus infection. Immediately afterwards suffered terrible achilles tendon pains and my Dr. had no idea what had caused this. After physio, acupunture and ice baths, exercises etc. I was on the mend in April 2008. In July 2008 I was prescribed Levaquin for pneumonia and started to feel tingling in my arms and legs. I referred to the symptoms to watch on the pharmacy list and there was no mention of tendons problems. I started to feel the same type of severe pain in my tendons again! I returned to the Dr. and still no answers for my pain. I returned to my physiotherapist in August 2008 and was referred to a chiropractor for laser treatments. In October my physiotherapist informed me of the possibility that an antibiotic could have caused this terrible pain. On the net all my pain was confirmed. I have since informed my pharmacist, my new Dr., Health Canada and the drug company. Through surfing the net I have added high absorption (chelated) magnesium to my diet. I have experienced some relief but the pain hasn’t disappeared completely yet. The drug company couldn’t give me a cure but warned me not to take “steroids”!

    Reply
  21. Tom Lamb Avatar
    Tom Lamb

    Angie:
    It sounds like you have had a difficult and unfortunate time with Levaquin.
    Let us know if you get any “new” information from the drug company, Health Canada, or anyone else that adds to what you have learned about Levaquin-related tendon side effects by means of your own research.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  22. Cindi Avatar
    Cindi

    I took Levaquin for several months several years back, during which time my knees hurt worse and worse, to the point where I could barely walk. After stopping the drug the pain went away slowly but they have never fully recovered.
    Is there a summary of the class action suit going on and what the parameters are, so I can see if it is worth my time? I hate to just choose one of these attorneys that pop up on a web search.

    Reply
  23. Tom Lamb Avatar
    Tom Lamb

    Cindi:
    Although there are a growing number of Levaquin lawsuits, these are being filed as individual personal injury cases — this is not a class action situation (BUT you will see some web sites using “class action” either because they are trying to capture the Google searcher who types in “Levaquin class action” OR they just don’t know how drug injury cases are handled…).
    I think most of the Levaquin cases being filed involve a diagnosed tendon rupture.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  24. Kevin Rooney Avatar
    Kevin Rooney

    Shane:
    I am just discovering the reports regarding Levaquin. I am now 48 years old and have been disabled for three years due to joint pain of “unknown etiology” I have pain ALL over my body and NOTHING has worked for me, not even narcotics. I am being treated by one of the best rheumatolgists in NYC and he even never mentioned this phenomenon.

    Reply
  25. Tom Lamb Avatar
    Tom Lamb

    Kevin:
    Thanks for letting us know about your Levaquin situation.
    We wish you the best in all aspects.
    Tom Lamb

    Reply
  26. topher Avatar
    topher

    To whom it may concern:
    I am writing you today with major concern of a medication that I was prescribed for a Prostate issue.
    In August of 2004 my urologist diagnosed me with Prostatitis and I was placed on the Bayer medical product, Ciprofloxin, 500mg 2 times a day for 60 days. Before taking this medication I was a very healthy and active 25-year-old male, just graduated from college. I began my regiment of this medicine with the hopes that I would fix my prostate issues. Over the following few weeks I began to have joint and muscle pain, in various parts of my body. I did not put together that this could have been the medication and I put it aside as I was getting out of shape and needed to become more active. I would take my medication 2 times a day at my work place and became fatigued and sore at some times. Around my 2 month mark I realized that something was happening and I brought it to the attention of my urologist who told me that Cipro could not be causing such affects and the only damage that might happen is to my Achilles tendon. I was then given a 3rd months prescription and sent on my way with a follow up a month later.
    I decided at this time that Cipro was not working for me in my favor and I would stop it. I stopped taking my doses in October of 2004 and within days I was very fatigued, incredibly sore all over, my mind was not mine and I was just falling into something that was very painful.
    I would go to the ER 2 times and talk to doctors about my condition. They kept brushing it off as depression, I was not depressed, I was in major full body pain. Within 1 months time I lost over 35lbs of muscle and body fat, I collapsed in weakness and soon following I visited a rheumatologist and I was diagnosed with Fibromyalgia. This is when my life ended and I was no longer able to do anything of physical nature, I was unable to wash my own hair, unable to run or walk fast, I was not able to even lift my own laundry.
    I was not able to work and lost my job. I kept going to doctor after doctor, emailing and talking to anyone I could to find help as to why this has happened to me. I found others and support groups of people whom had taken doses of CIPRO or LEVAQUIN and ended up with disabling conditions. Many of them also had drug induced Fibromyalgia and other problems. These people also have been trying to convince doctors and hospitals that this medication has also hurt their physical beings. With this no one believed them either.
    I am a victim of this medication. I was perfectly healthy and able before I took this medication, my only problem was a prostate infection. When I came off of the Cipro I had ruined my body and spirit. I am now un-employed, I have no use of my degree in teaching, I have lost respect of family and friends due to my inability to attend many things although I appear normal looking. I have had to give up trips and gatherings due to my daily battle of full body muscle and joint pain. Cipro and Fibromyalgia have taken away my youth and my future. Half of myself has died because of the disabling affects of this anti-biotic.
    No one will listen, but I will continue to fight along with other victims until someone believes or hears my voice and pain. I continue to talk to any doctor that will listen, sadly some of them believe that Cipro has done this to me but will not help me due to the fact that their job is on the line and they care not to get involved in such a case of confusion.
    My body is ruined from this drug. I now live daily with chronic body pain, muscle pain, joint pain, cartilage damage, muscle damage, numb patches of nerve damage and a very depressed state over this pain that consumes my whole being. I am unable to work and I am unable to collect social security, for in my young life I have not earned enough to be helped. I now have to rely on the help of others to get me along as I try to recover and get my body back to any health it can reach.
    I want to be recognized, I want Bayer Company to take responsibility for what its medication has done to my body and life. Not to mention 100’s and thousands of other people like myself that are not heard and live in this pain.
    I would like a response and help for my situation. I am going to spread the word on this and also contact the numerous victims that I know to also get on the wagon to make our voices heard. As of now the support groups are overflowing with people who are crying for help.
    
Ive lived without a job, major debt, pain, and medical issues for the past 5 years.. my doctors still call me a hypochondriac.. and that Cipro could never hurt anyone… then the other half of my doctors believe this.. and say it IS the cause… I also have FULL medical documentation from DAY ONE. I went in HEALTHY.. I came out CHRONICALLY ILL.
    I belong to MANY internet and physical support groups that include hundreds of victims that are just as bad if not worse than I am. I have every piece of documentation, websites, letters, people, medical files, all of it to provide. I have been emailing lawyers and any help I can reach for 5 years.. NO ONE HAS HELPED. Not one person has stepped up to do anything. All I can do is keep trying. My life is ruined from this medication and only I can put it back together.
    I thank you for any help you can provide.. Any help is a step forward.
    Kindly, Christopher
    TopherEmail@gmail.com

    Reply
  27. Tom Lamb Avatar
    Tom Lamb

    Christopher:
    Thank you for this extensive report on your unfortunate experience involving the use of Cipro.
    While I cannot help you with any legal claim nor any other type of claim against Bayer, perhaps someone who sees this Comment can give you some guidance or assistance in that regard.
    I wish you the best in all aspects going forward.
    Tom Lamb

    Reply
  28. Isa Fores Avatar
    Isa Fores

    My story is very similar to Christphers. I was a fit strong athlete and went in with bronchitis. Within 2 days of Avelox I collapsed and lost everything, they gave me more and now I’m ruined! I couldn’t even walk for 4 months. Every Dr. thinks I was depressed… ya right! I’m depressed with them covering drug companies butts! How do you get depressed from a bad cold!
    My life is getting back, and my legs have recovered mostly, until I get sick, then the leg sensations, pain, weakness and nerve damage reappears again. It’s been 4 years and I’m back in bed again. I am scared to go see any Dr, cuz they just think I’m wacko, but I know it’s the AVELOX… help…!!!

    Reply
  29. Shelby Avatar
    Shelby

    Is there anything that can be done now? My aunt has had a life long problem with her tendons, just wanting to see if there is still a lawsuit in place?

    Reply
  30. Lee Baas Avatar
    Lee Baas

    I was given Avelox for pneumonia also, in August. The pain in my hands and feet, legs and arms has been astonishing. I’ve been putting heat packs on my hands and feet and I walk like a little old lady…. I’m usually very active but having difficulty. I have to massage my hands, wrists and feet to deal with the pain. I also have an area on the side of my foot, under my ankle bone that screamed pain when Imoved a certain way for months and us now numb to touch. Are these Avelox symptoms? How do I find out?

    Reply
  31. Lee Baas Avatar
    Lee Baas

    I was prescribed Avelox for pneumonia in August. I have had very bad pain in my feet, hands, wrists and lesser pain in my arms and legs. I had a very bad pain in my foot, a tearing pain under my ankle bone, that only occurred during a certain movement. I could walk on it as this area isn’t needed for walking. Now this area is numb? I am walking like a little old lady a lot of the time. I have had to put heat packs on my hands and wrists and feet just to be able to cope with the pain sometimes. I have multiple allergies and cannot take pain medication except paracetamol. I am usually very active, despite being 56 I’m known as the energiser bunny. My elbows hurt and now my knees are starting to ache. I am concerned as I have suffered an almost complete rupture to an Achilles’ tendon previously. One small piece was still attached. I have a very high pain tolerance level, but have been struggling with this pain. What is the best course of action? How do I know it’s avelox caused? I surfed the net as the pain is spreading rather than going away. Found this site….

    Reply

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