Drug safety officials Tuesday imposed the government's most urgent safety warning on Cipro and similar antibiotics, citing evidence that they may lead to tendon ruptures, a serious injury that can leave patients incapacitated and needing extensive surgery.
The Food and Drug Administration ordered makers of flouroquinolone drugs - a potent class of antibacterials - to add a prominent "black box" warning to their products and develop new literature for patients emphasizing the risks.
Tendon ruptures are normally thought of as sports injuries, generally occurring among men in their mid-30s. The link to treatment with the antibiotics is highly unusual, and scientists still don't fully understand why it happens. However, FDA officials stressed that many of the serious injuries appear to be preventable if patients stop taking the drug at the first sign of pain or swelling in a tendon, call their doctor, and switch to another antibiotic.
The two leading drugs covered by the warning are Cipro, made by Bayer, and Levaquin, which is made by Ortho-McNeil. Cipro became a household name during the anthrax attacks of 2001. It is effective against that deadly bacteria, and is among the drugs stockpiled by the government in case of a bio-terror attack. In everyday medicine, Cipro is often used to treat urinary tract infections. Levaquin is generally used to treat respiratory infections. The FDA warnings do not apply to fluoroquinolone drops used to treat eye infections.
The FDA's action came after the consumer group Public Citizen petitioned - and later sued - the agency for such warnings. Regulators took too long to act, complained Sidney Wolfe, head of the consumer group's health section. Many injuries "would have been prevented if patients and doctors had known a pain in the tendon is an early sign that leads to rupture," Wolfe said. Public Citizen's original petition was filed nearly two years ago.
FDA officials pointed out that prescribing literature for the drug class already carried clear warnings of the risk of tendon rupture. They said the agency acted to emphasize the warnings because continued reports of injuries indicated that the message may not have gotten through to doctors and patients.
"The continued reports demonstrate additional steps are warranted to better manage the risk of tendon rupture," said Renata Albrecht, director of an FDA office that focuses on unusual microbes.
FDA officials said they had received several hundred reports of tendon ruptures, but would not cite a specific number. Wolfe, of Public Citizen, said the number was 407 at the end of 2007, with another 341 reports of tendinitis. He continued to criticize the agency, saying it should also require drug makers to send individual letters to doctors about the risks. FDA officials said manufacturers could choose to send such letters on their own.
Tendons are cords of tissue that join muscles and bones, and are essential in movement. The most common kind of rupture reported to the FDA involved the Achilles tendon in the heel, but some also involved the rotator cuff in the shoulder, and tendons in the hands, biceps, and even the thumb.
Some of the ruptures reported to the FDA occurred without warning - the patient felt a snap or pop soon after starting treatment. That suggests flouroquinolone antibiotics may be toxic to some people, the FDA said.
But typically, patients felt some kind of pain or inflammation for a week or two before they suffered a tendon rupture. That suggests that many of the most serious problems can be avoided if patients stop the drug, officials said.
The FDA's analysis found that patients with the highest risk of problems include people over 60, those with kidney, heart and lung transplants, and those also taking steroids.
Manufacturers called the tendon ruptures a rare side effect. They said are complying with the FDA order and remain confident that the drugs' benefits outweigh their risks.
Healthy Trust Immediate Medical Care serves the Chicago North Shore Communities of Lake County, Wheeling, Prospect Heights, Lincolnshire, Deerfield, Buffalo Grove, Northbrook, Highland Park, Long Grove, Riverwoods, Des Plaines, Palatine, Glenview, Highwood, Northfield, Libertyville, Winnetka, Arlington Heights, Mount Prospect, Lake Bluff, Lake Forest, Mundelein, and Bannockburn.
18 comments:
Tendon rupture is the least of the patient's concerns. This class is associated with irreversible peripheral neuropathy, fatal liver and kidney damage, fatal hypo and hyperglycemia, SJS and TEN, toxic psychosis, spontaneous ruptures not only of the tendons but also muscles, ligaments and cartilage, the list of serious adrs is boundless. More than half of the drugs found in this class have been removed from clinical practice due to severe and even fatal adverse reactions.
I just received a report of a 14year old male who tore the cartilage in both knees requiring extensive surgical intervention as a result of being on levaquin to treat a nail infection. Not to mention they young lady who has been in a wheelchair for the past decade due to the damage done to her tendons which rendered them beyond surgical repair. She was given cipro for an earache.
Within the NDA (new drug application) for levofloxacin we find clinical studies that revealed an adr rate in excess of 40% (one or more reactions) and a number of listed fatalities. We find these same numbers with all the NDAs for this class. This tendon issue we are now discussing was first revealed to the FDA back in 1982 (bailey et al). The FDA did NOTHING until Public Citizen filed a petition in 1996 seeking both black box warnings and dear doctor letters. The FDA did neither. Another petition was filed by the Attorney General of the State of Illinois in 2005 seeking these same actions. In 2006 Public Citizen once again petitioned the FDA. Rather than respond to these petitions as required by law, the FDA stonewalled the petitioners for more than three years. It was not until suit was filed in Federal Court by Public Citizen to compel the FDA to respond to these petitions did the FDA do anything.
And what they did was nothing more than a 'slap to the face' to those of us who have had our lives destroyed by these drugs. It is far too little, far too late. And we would not even be tossed this 'bone' if this lawsuit were not pending. This is nothing more than a blatant attempt by the FDA to avoid full disclosure of the true safety profile of this class which will be required when they lose in Federal Court.
Bayer issued a European "Dear Doctor Letter" in February of 2008 in regards to fatal liver injury as a result of being on Avelox. Yet we see no such letter being issued here in the States, nor do we see the FDA requesting one either. This class has been crippling and killing patients since the mid sixties. For more than forty years now the FDA has hidden the true safety profile from both the patient as well as the treating physician.
Those who have an interest in reading this forty years worth of medical journal entries, case reports, newspaper articles, clinical studies, etc., that documents all that I state here are invited to log unto www.fqresearch.org The FDA is also grossly misleading when they state that the risk factor is one in one hundred thousand. The actual risk is .5% to 16% depending upon which citation you prefer to reference as well as the year in which it was published.
I find the manufacturers to be grossly misleading the patient and physician alike when they state that this class is a safe and effective antibiotic with minimum side effects. I have forty years worth of medical documentation that proves that they are anything but for those who care to read it, rather than this line of misleading and false information being provided by the FDA.
Mr. David T. Fuller
Director
Fluoroquinolone Toxicity Research Foundation
www.fqresearch.org
fqresearch@aol.com
davidtfull@aol.com
David...that was very informative, but how else would you treat a urinary/bladder infection or STD?
The drugs most often used to treat UTIs are trimethoprim (Trimpex), trimethoprim/sulfamethoxazole (Bactrim, Septra, Cotrim), amoxicillin (Amoxil, Trimox, Wymox), nitrofurantoin (Macrodantin, Furadantin), and ampicillin (Omnipen, Polycillin, Principen, Totacillin).
The fluoroquinolones are to be considered a drug of last resort when all of the above fail. This is a matter of common sense. I do not advocate the banning of this class. I do however advocate the proper and rational use as well as a full and complete risk/benefit discussion taking place. But this is impossible when the physician is clueless regarding the safety profile of a drug.
The question becomes whether or not the patients infection is of such a nature that the risk of killing or crippling the patient is warranted. If they are in immedate danger of losing life or limb this is a no brainer. You use the drug. You hit hard and you hit fast with the most potent drug in your arsenal and then retire to the chapel with the family and pray it works.
If the answer is "NO" then you look to see what other drug is available that would be just as effective and achieve the same results, a drug with a much safer profile. Again, a no brainer. Perhaps the patient will suffer longer, and be more uncomfortable. But how would this compare to being crippled for life instead?
We treated bacterial infections long before the fluoroquinolones came into being. These older drugs still work even today. As such I fail to see how one could possilby justify the 600 millions prescriptions, 10% of the entire world's population, to be justified considering the horrendous safety profile of this class. I doubt that even 1% of these prescriptions were for a life threatening bacterial infection.
If we were to apply the 40% adr rate found with levaquin to this number we are looking at 240 million patients who have suffered an adverse reaction. So why are we not seeing such numbers within the FDA's database? Because first no one is associating such reactions to the drugs, and secondly those who do are not even aware that medwatch even exist, let alone making a report.
The reason we don't see more litigation is the same. Attorneys are as ignorant of this profile as the medical community and it is all but impossible to find an attorney to even take your case.
An additional note the fluoroquinolones are no longer used to treat an STD. The CDC removed that recommendation years ago.
I am a 43-year-old woman. In December of 06, I was prescribed Levaquin and then Avelox. I took them for a total of 17 days. Within 24 hours, I felt like I was in a fog. Within two days, I was awakened from a sound sleep with severe muscle cramps in my thighs. My leg pain was excruciating. I was also experiencing electrical and burning sensations all over. I called my doctor. She didn't tell me to stop taking my antibiotic. I continued to take it, never attributing my pain to an antibiotic. Over the next 6 months, I developed tendonitis in every possible tendon in my body. As a professional pianist and piano teacher, I couldn’t practice the piano for 2 months. I couldn’t teach for a whole month as I could barely hobble around. I couldn't drive a car due to the pain in my calves, thighs and knees for 6 months. I couldn't walk 20 yards without my legs giving out. I couldn't even rest my foot on the floor for more than a minute because of the pressure on my tendons. I had to constantly keep changing my position from sitting, to standing, to lying down. I had muscle twitching all over and severe insomnia for about 5 months. I had terrible night sweats, but could never get warm during the day. I lost 13 pounds within 2 weeks. I spent over $3000.00 on medical tests to rule out everything from Celiac's disease to neuromuscular diseases and Sjogren's syndrome. Of course, you can imagine the anxiety over the thought of having a disease like ALS. Gradually, I began to get better. Nearly 2 years later, I have mostly healed. However, I do continue to get tendonitis if I am not careful. I workout daily, as this seems to help ease the arthritis I now have. However, I have to be very careful to not over do it. I have nerve pain in my shoulder and neck that isn't getting better. My husband, an MD, was ashamed that he didn't recognize the symptoms and stop me from taking the drug. He and I both just want doctors to inform patients and recognize these reactions. If I had only known within the first 24 hours to stop taking the drug, I probably wouldn't have had such a severe reaction.
I was a healthy 42 year old male who took Levaquin for a sinus infection. The same day as the Black Box Warning was issued; I was having my third tendon reattachment surgery. I have to wait at least 6 weeks before I can undergo yet a fourth tendon rupture reattachment. At least it takes my mind of the Achilles Tendinopathy, joint pains, headaches, uncontrolled muscle twitching etc. I consider myself one of the lucky ones since so far it has not affected my kidneys, liver, heart, eyes and other side effects that many are dealing with from this class of drugs. I would urge a real journalist to take the time and look at the real number of cases. The Fda numbers are misleading. The clinical data coming from other counties are showing much higher rates of tendon ruptures and other life threatening side effects.
Fluoroquinolone antibiotics have damaged many people. I know of this severe damage on a personal level since I suffered such and adverse reaction to the fluoroquinolone antibiotic Levaquin myself 22 months ago. Since then I have had daily pain and disability of my nervous and musculoskeletal systems and for several months had endocrine and gastrointestinal problems as well. The disability and damage caused by fluoroquinolones is long term and may gradually escalate in that more severe problems such as worsened neuropathy, neuromuscular disorders, musculoskeletal disorders and endocrine disorders once initiated by the fluoroquinolones may develop with a delayed and insidious progress.
This progression of the fluoroquinolone toxicity syndrome is well know by its sufferers and not recognized by health care givers. There has been no investigation in to the reactions. This lack of attention stems from of an antiquated FDA reporting system and the under-representation of the seriousness and frequency of the adverse reactions. The makers of fluoroquinolones have no interest in investigating adverse reactions when doing so will hurt them financially. It is only recently with the weight of litigation pressing down that the FDA has published its incomplete and grossly inadequate boxed warning about the potential for fluoroquinolone toxicity.
I have met many other patients suffering from the adverse effects of fluoroquinolones. Many of them reside in my community including 3 physicians and more than twenty patients.
Although these drugs may be life saving in certain infections when less toxic antibiotics may fail, they have been promoted for use as first line treatment for sinusitis, and urinary tract infections, and are often given indiscriminately to unsuspecting patients by uninformed and cavalier physicians for such benign illnesses as the common upper respiratory infection. Unfortunately for many patients they are trading a mild short term medical problem for a serious long term one.
Sincerely,
Todd Plumb MD
On my 23rd birthday I started ciproI only took 3 doses of cipro in total before realizing what was happening... I went from being a very healthy 23 year old male who was athletic for over 10 years doing Karate, Yoga, Football, Judo and other sports, I eat an extremely healthy diet, no bad foods at all, and generally take care of myself in everyway possible, I have never drank alcohol and never smoked... I have all the blood tests and other tests to prove how healthy I was. After taking the ciprofloxacin my life completely changed in an instant, for months I had to crawl around my house beacuse of the pain in my achilles tendons. I noticed the side effects approx two hours after taking cipro... however my doctor told me to carry on taking it! (I stopped myself after 3rd dose).
After my very first dose of cipro I had a cascade of symptoms that I never experienced in my life before such as; Bilateral Achilles tendinitis, Tendinitis in both wrists, Chronic insomnia where it would take 5 hours to fall to sleep then I would be waking up every 1 hour and this continued for 4 months. What is interesting is that I have never had insomnia in my life before cipro. I also experienced chronic nightmares, moderate peripheral neuropathy (burning, tingling, numbness), constant body tremors, dry eyes, dry mouth, dry skin, pulsating sensation in my stomach/neck/hands, pulsatile tinnitus, tinnitus (4 noises), muscle pains, joint pains. Eye flashes, blurry vision, eye floaters, static/snow vision, inability to adjust from light to dark (right eye), twitching, dizziness, stiff neck, head pressure, eye pain, ear pain, difficulty swallowing, aspiration, GERD, lack of appetite. I also had massive increase in spider veins, nail ridges, constant wrinkled fingers, nail growh abnormalities... and my skin become thinner around my body (breakdown of collagen?).
It has been 9 months now since I had my reaction and I still cannot function properly because of my tendinitis... about 80% of my symptoms have lessened or have now gone away. I am improving at a very slow and frustating rate. How can I go from being extremely healthy and having just a minor infection to not being able to function and feeling like I had aged 50 years in one night. I have lost thousands of pounds in earnings and have not been able to work consistently since my reaction.
I have seen literally thousands of people in the same position as me, a significant portion of them were healthy and young like me, and now are disabled. How can the true devestation of this class of antibiotics be revealed if things like tendon damage does not show for months after the last dose? I feel the numbers reported are probably very small because people are not associating antibiotic use with tendon problems, and other problems as I mentioned above. From the moment I took the antibiotic I had a cascade of symptoms that never stopped showing up until about 4 months post-cipro. From there I healed from most of it but now have several injuries which are likely to be with me for life, or until medicine can fix them. I just want my life back, and for doctor to prescribe quinolone drugs when only absolutely needed
I took Levaquin 2 months ago for a UTI. After the third dose, I went from a healthy 34 yr old to a 100 yr old woman. I had myalgia, extreme anxiety and panic, insomnia, tremors, neuropathy, tinnitus, blurred vision, and joint and tendon pain. Most of the symptoms have either diminished or gone away except for the joint and tendon pain, tinnitus, blurred vision, slight neuropathy, and some anxiety.
There has not been one day in the past two months that I have not been in pain. Both my achilles tendons, both knees, both wrists, both elbows, both shoulders, and my right hip take turns hurting and aching. My quality of life has greatly dimished.
It is outrageous that there is a medicine out there that can do this kind of havok on a person's body. Of course, most of us realize that all drugs can cause adverse reactions in some people. But we expect those reactions to be short-lived. I never imagined that adverse reactions to a drug can continue and actually get worse once the drug is discontunued. There are so many quinolone victims out there. Just go to the Yahoo health forums "quinolones" and "fqtoxicity."
What makes all this so much worse is that the medical community is so oblivious to what is happening.
Seena Darwish
My reaction to avelox started almost three months after I took the drug for a sinus infection, in March, 2005. I did not have the muscloskeletal problems that many have, but I had the vision problems, extreme fatigue, dehydration, brain fog and short term memory loss, neuropathy, and tinnitis. Some of these ADRs stay with me today.
The medical community simply does not acknowledge the danger of fluoroquinolones. In 6 months of going from specialist to specialist, no one could tell me what was wrong with me because nobody is looking for ADRs to drugs in their diagnostic paradigm. And because they’re not, people are being mis-diagnosed.
I feel this is nothing short of a health crisis in this country. These drugs are causing major damage to people and incur great cost to our health care system. In my case, I had probably 30K worth of useless tests. Chronic Fatigue Syndrome and Fibromylgia are possible results of fluoroquinolone ADRs. I know that FQ ADRs mimic arthritis in older people. FQs have been known to cause diabetes. And the list goes on.
Black box warnings should include the FULL SPECTRUM of the ADRs assocoated with these drugs. The FDA is only cutting their losses with this warning in response to a lawsuit by Public Citizen. The FDA should insist on Dear Doctor letters in the USA like there are in Europe. But the FDA is not protecting the citizens of this country; that much is evident.
"FDA Orders Black Box Warning On Antibiotics" I have a problem with these warnings. I believe them to be misleading as well as being totally insufficient. This is based upon my personal experience from watching my husband become disabled throughout the years. Mentioning people over 60 as the higher risk of having a tendon rupture is just 1 thing I have a problem with. I believe people younger than 60 had the most reported ruptures. My husband was in his early 40's when he had his first rupture. "Rare occurrence of tendinitis & tendon ruptures can occur while or AFTER" is something else that I believe is misleading. How many people know that AFTER means much more than a few weeks. My husband took Cipro & around 11 months AFTER he had a rupture. He took CiproXR & around 11 months AFTER his tendons started to rupture again. AFTER means quite a bit more than a few weeks. I have another problem with reading "physicians should warn their patients of the risks". Who's going to warn the physicians so that they can warn their patients? My husband saw almost a dozen different doctors & not 1 of them associated his 6 ruptures to Cipro. They had no idea what caused this. Tendons aren't the only things that can rupture. Muscles can rupture also. These ruptures have occurred with no warning that anything was wrong. There are also "other" severe adverse reactions. Thinking that tendonitis & tendon ruptures is the only thing you have to be concerned about taking these medicines is wrong. Dear Doctor Letters SHOULD be sent to every single doctor along with more clarity on the issues like "after", "age" , & "all the adverse reactions".
Every morning when I open my eyes, I awaken to this nightmare. There is a “sickness” that feels like my body has been poisoned. My hands and feet are swelled and sore…my entire body is stiff and painful…heart-palpitations, vibrations throughout my body…ringing in my ears…bleeding specks of sores on my skin…and a full, bloated feeling in my gut…I feel like I should be dead. It is only by the grace of God, and the love of my 2 children that I am able to pull myself up out of bed, and make it painfully down the stairs. Crying will do no good, as I know I must be strong to fight this horrendous ordeal that has become my life. Knowing that there are others who are living this nightmare gives me a sense of strength…and compassion. There are no more words to described what we are going through emotionally, let alone physically. How could something so unbelievably criminal have happened to us?? And why is this insanity being allowed to continue?? How many more innocent people will have their lives destroyed…how many more must suffer…how many more must die…before something is done?? Someone tell me, what will it take??
Diagnosed w/ arthralgia, trigeminal neuralgia, tendinitis both elbows, enlarged lymph nodes…
still seeing doctor after doctor, and specialists who can only treat the “symptoms”, not the cause.
The Black-Box warning for tendon damage is hardly sufficient and long-overdue.
The poisons that robbed my children of a mother were AVELOX and LEVAQUIN…20 pills. I traded a sinus infection for this life of pain and misery.
~Shells~
I think it's great to see more publicity about fluoroquinolone side effects. Many doctors forget that patients have a right to be informed about side effects, or perhaps doctors are not informed of side effects well enough to have intelligent conversations about them with their patients. I had a conversation with my doctor about possible side effects of Levaquin before I took it, and my doctor never mentioned tendon disorders, and convinced me to take the Levaquin since it'd be no problem for me to switch to a different antibiotic if I did have side effects. Or so we both thought.
Luckily my mom came across a publication by Public Citizen that talked about tendon damage by fluoroquinolones when I was 7 days into my 14+day course of Levaquin. I'd been wondering why my achilles were so sore and my calves so rock hard. Four years later with continued tendon and nerve pain, I'm still regretting that initial assumption that side effects go away when I quit ingesting the pills. But if this is what the result of 7 days of Levaquin is like, thank goodness for that article by Public Citizen that kept me from taking 14 days worth of pills. I am a formerly healthy, active 35 year old (31 when I took Levaquin).
In January 2008, I was 37 years old, married with 3 kids under six and in reasonable good shape considering I had had a partial elbow replacement in September 2006 from a fall. That took a real downward turn once I went to my doctor for what I thought was a sinus infection. At the visit the doctor without doing any test wrote me a prescription for ciprofloxin, which I had never heard of and definitely never used before. Of course I filled said prescription only to be somewhat surprised when I read in the warning that this was a drug used for anthrax infections. Like a good patient, I started the medication even though its strength concerned me only to have burning pain in my surgically repaired elbow and my achilles tendons at which time I called my doctor per the instructions on the medication warnings. The doctor totally ignored my complaints, saying they had nothing to do with the meds and told me to keep taking the cipro. Once again, I did what my doc suggested only to have increased tendon/muscle pain over the next two days and finally found myself having an anxiety attack after 8 cipro tablets. I stopped the medicine and made an appointment with my doctor. For the two days I had to wait to see my doctor, I was in bed with terrible anxiety, severe muscle/tendon pain/weakness and all sorts of neurological issues like brain fog, neuropathy,and spatial proximity distortion that I had no knowledge of before taking this drug. When I did go to the doctor he acknowledged that cipro could have rare side effects but didnt think my issues were caused by the medication and told me to give it a month to see if everything went away and if not come back and we would start running tests to discover my real problem. I left feeling both betrayed and scared , because my doctor of the last fifteen years had basically disregarded all my issues. So I have struggled for six months by myself trying to fix these side effects. At present I still cannot say I am 100% back to normal again. Each day has been a day to discover what side effect I will have today. One day I will have severe tendon pain/tightness then that will resolve and brain fog will creep up then that resolves only to have burning neuropathy plague me for a few hours or days. The side effects from these drugs are exactly that nothing short of a modern day plague. No one acknowledges they exist and no doctor that I have seen has any idea what to do for them except to ignore them or to blame them on another disease, yet every day I have to deal with them as best I can.
I had surgery in 2000 to remove a urinary bladder stone caused by a previous unnecessary and unsuccessful surgery for minor stress incontinence. I was given Cipro for weeks prior to the surgery and after. I was told that the inside of my bladder looked like raw hamburger meat. I continued to get UTIs while the bladder surface was healing. I was given Cipro many times over the next 5 years by 3 different physicians. I was 60 or over at the time. I was told by 2 physicians that I needed to be on Cipro for a year. After 5 months in 2005, I stopped taking the drug since I developed severe ear pain. I experienced about 20 side effects, tendon rupture, neuropathy, sensitivity to noises, balance problems, rashes and itching, sun sensitivity, fatigue, vision problems, to name just a few. I'm still disabled and suffering. What in the world will a black box do? This drug needs to be withdrawn from the market.
My name is Leslea and I am a Clinical Laboratory Manager, have been a Medical Technologist for almost 30 years. I am very well respected by the medical staff at my facility because if I bring up a subject, perhaps a laboratory protocol that I want to put into place or changed, I have done my homework on the subject.
With that in mind, I want to urge physicians to take heed to the fact that fluoroquinolones are not safe for a very large segment of the population. There are literally thousands and thousands of people whose lives are forever changed because of the quinolones.
I know that most, if not all, facilities with microbiology departments put out an antibiogram, at least annually, for the medical staff to reference. Please use your antibiograms to pick the least toxic and most effective antibiotic for your patient.
Use the quinolone class only as a last resort, after other antibiotics have failed or the patient will expire if they aren’t used. Using the quinolones routinely just doesn’t make sense when other antibiotics will work. Keep in mind if this class of antibiotics continues to be used so nonchalantly they will become ineffective due to bacteria developing resistance to them.
I have personally experienced multiple system adr’s to the quinolones, and know a multitude of people like me. That is why I am writing this, I want to prevent the number of people that are damaged by quinolones from growing exponentially.
The adr’s to the quinolones are grossly under reported due to the fact that a lot of reactions aren’t recognized, but are diagnosed as an unrelated problem. If the number of adr’s to quinolones were accurately reported to the medical community, no physician would ever routinely prescribe quinolones again, unless he was some sort of sadist.
My motivation for writing this is honorable, our term would be risk management in the medical community, for the layperson it would be a passionate desire to prevent others from suffering like I am.
Just in case you are wondering, my first reaction to a quinolone caused damage to my tendons particularly my left knee. The tendons were so weak that my knee dislocated 6 times over a 7 month period, I probably should have been in a wheel chair, but I needed to work. I have a permanent baker’s cyst in that knee. The tendonitis was so painful that walking was more like hobbling.
My second reaction made my first reaction seem like a walk in the park. When I mentioned multiple systems earlier, I meant CNS, muscular, skeletal, soft tissues and connective tissue damage. Four and a half years post two doses of Avelox, I still have a multitude of symptoms, some that are not going to resolve. Although I am in severe unrelenting pain, I consider the worst part of my reaction to be the CNS or brain damage.
I have debilitating depression, which I never had prior to this. But the thing that takes the cake is the following: I am sure you can imagine that I am or actually was above average in intelligence, Avelox has destroyed my short term memory and has made me struggle to find simple everyday words when carrying on a conversation. My nickname used to be “The Steel Trap” because I never forgot anything and could recall verbatim conversations no matter how long or short the amount of time that had elapsed. My memory was what is called photographic in nature. You might be tempted to say, well you are getting older, well I don’t believe that CNS changes due to aging happen overnight unless there is a stroke involved. That, and the fact that I am not alone with this reaction, speaks very loudly to the truth of the matter.
I will quickly list the other damage I am dealing with; peripheral neuropathy, myofascial damage in my right hip that has lead to permanent gluteus median adhesions after tearing. I have chronic muscle spasms and knots in my right hip and shoulder, this is the cause of the severe unrelenting pain, the shoulder knots and spasms lead to horrible tension headaches. I also have to take Valtrex to keep shingles at bay, another wonderful symptom of the nerve damage. My tendons and ligaments in my right knee are tender to the touch and painful, my vision is altered due to floaters and blurring, luckily laboratories are notoriously noisy so I don’t notice the tinnitus too much. I could go on and on, but you get the picture. By the way, I was a healthy active person prior to this reaction, I was 47 at the time and most people would guess my age at 35 because of my personality, strength and agility, they were always shocked to find out how old I was.
Please help me in preventing any other healthy individuals from experiencing this nightmare.
I also challenge you to do your own research into the real picture of this class of antibiotics, quit taking the word of the FDA or pharmaceutical companies, they have an agenda, but it is less than honorable. You can start by going to www.fluoroquinolones.org .
Thank you for your time.
In December of 2007, I became ill with pneumonia. My doctor prescribed Levaquin 500 mg once a day for ten days. The only reaction he said I might notice is nightmares. Well, that was an understatement! After I took the first pill, I reacted very negatively. I went to bed that night with severe heart palpitations and I had the most terrifying panic attacks of my life. I really believed that I might die that night. I could not fall asleep. I kept “hearing” someone screaming in my ear every time I was almost ready to go to sleep, and I was having double vision. I was tossing and turning and freaking out. I finally went downstairs and laid on the couch so my husband could get some sleep. I got terrible sleep for only about 2 hours that night. I also had a terrible “headache” which was more like a sharp pain in the back of my head that lasted the entire time I was on the Levaquin. In the morning, I called my doctor to tell him that I had a reaction. His response to me (through the nurse) was that I had anxiety. He said I should keep taking the Levaquin and also take the ativan he was going to prescribe for me. At the time, I figured he knew best and that this reaction would be temporary. I had to somehow get through this course of Levaquin.
Within two weeks of stopping the Levaquin, I began having a burning pain in my left arm on the inside of my elbow. I wondered if I had a blood clot. That lasted a few days before it started to spread throughout my whole arm. I was experiencing agonizing, throbbing pain. Within another couple of days, my other arm was affected. I couldn't bend or straighten my arms. In addition, I was still experiencing heart palpitations and insomnia. Soon the pain spread to my legs. My knees hurt so bad, I couldn’t bend them to go up or down the stairs. All I could do was to sit and cry. Within the next few days and weeks I had the following adrs: blurry vision, dry eyes, dry mouth, ear pain, neck pain, shoulder tendonitis, popping, cracking joints, dizziness, nausea, diarrhea (I lost 6 pounds in two weeks), headaches, muscle twitching, muscle cramping, muscle jerking (myoclonic jerks), joint pain, EXTREME muscle weakness and soreness. My legs could barely hold me up and I was walking very slowly and stiffly. I couldn’t stand for more than a few minutes. I had pulsating, tingly neuropathy in my legs and feet that was very uncomfortable. My ankles were aching, my fingers were stiff, I had burning pain in my knees, I was even having spasms in my eyes. I had terrible pain and achiness in my lower back, I became very sensitive to noises (if things were quiet and I heard a noise, the right side of my face would spasm).
I am now almost seven months out from the initial reaction, and things have not gotten much better. I am still experiencing many of my original ADRS, just not as intensely as I was experiencing them. My worst problems are still pain in my left leg, stiffness in my feet, lower back pain, nervousness and internal tremors, blurry vision in my right eye, gastro-intestinal problems, intermittent tinnitus, and tachycardia.
I believe that reactions to FQs are grossly underreported because many people do not make the connection between their symptoms and the drugs. I am actually one of the lucky ones to have made the connection to prevent a repeat in the future. Also, I tell everyone I know about what happened to me and I believe I am saving people from suffering the same fate.
Bob from Lincoln UK
I took 7 days of a 28 day course of Ofloxacin in November 2007
Had to stop the meds due to intense pain in my knees and shoulders.
4 weeks in: -
hardly walk with severe swellings in knees , ankles and hips.
6 weeks in: -
Toxic psychosis, depression, anxiety and suicidal thoughts
9 months in: -
Pain in joints and muscles, tendons popping in every single joint but worse in spine.
Chronic back pain
Worsening of pre existing Tinnitus
Burning sensations on hands and feet.
Flushing sensations
Bee like stings all over
Feeling of being cold even in hot weather.
Urinary problems
New symptoms manifest themselves every week
Symptoms are progressive and not transient as stated in the prescribing literature.
I am 43 but feel like 63.
If you have Prostatitis or any infection that HAS NOT been cultured refuse Fluoroquinolones until they can confirm its life or death, honest it is just not worth the risk.
BE WARNED YOU QUALITY OF LIFE MAY DEPEND UPON IT!!!!!!!!!!!
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