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July 19th, 2008

“Floxins” and the black-box warning: Anyone notice? Anyone care?

Fluoroquinolones — the “floxins”, every medical house officer’s favorite antibiotic class — will carry a black-box warning about the risk of tendinitis and tendon rupture. We’ve known about this side effect for years, why now the change? In FDA speak:

FDA’s recent evaluation of the medical literature and the post-marketing adverse event reports submitted to the Adverse Events Reporting System (AERS) confirmed that serious reports of tendinitis and tendon rupture with the fluoroquinolones continue to be reported in similar or increased numbers.

In other words, the rate of this side effect hasn’t increased. Or it has.

Regardless, it’s a good idea to get this information out to practitioners. The use of these drugs is so pervasive I suspect some clinicians believe that patients suffer from levofloxacin deficiency. (Cure: give levofloxacin.) Since they’re used so commonly, even rare severe side effects are important.

And when Achilles tendon rupture occurs, it’s pretty devastating. Pain, then surgery, then immobility for months. I’ve seen 3 cases, one of which ironically occurred in a pediatrician — who I bet won’t prescribe a quinolone to kids even if the drugs ultimately get approved for pediatric use. One hopes that telling a patient to stop the drug and avoid exercise if pain or swelling occurs while on a quinolone might prevent the tendon from rupturing.

Will this change prescribing practices, either in the hospital or office setting? Doubtful — the side effect is pretty darn rare, and it seems to be a local ordinance in some hospitals that every patient must receive at least one dose of levofloxacin before discharge. Nonetheless, it’s a good reminder that even our best drugs have some warts.

18 Responses to ““Floxins” and the black-box warning: Anyone notice? Anyone care?”

  1. david fuller says:

    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 http://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
    http://www.fqresearch.org
    fqresearch@aol.com
    davidtfull@aol.com

    You may also have an interest in the comments made in response to the recent video presented by John Hopkins in defense of this class. I have read more entertaining fairy tales written by the Brother’s Grimm, than the ‘fairy tale’ that this doctor had narrated within his video.

    Here is the link:
    http://tinyurl.com/5vqfsy

  2. ~Shells~ says:

    Something doesn’t make sense. The fluoroquinolone class of “antibiotic”, a toxic chemotherapeutic agent developed to treat a biological weapon, Anthrax, becomes the drug of choice to treat common infections…causing severe, often permanent, disabling reactions affecting every organ, every system of the body, damaging our DNA at the mitochondrial level, such as:

    Central Nervous System:
    - toxic psychosis
    - panic/anxiety
    - insomnia
    - seizures
    - tremors
    - dizziness
    - confusion
    - depression

    Peripheral Nervous System:
    - numbness
    - pain
    - burning
    - tingling
    - stinging
    - weakness

    Musculoskeletal System:
    - joint pain
    - tendon pain
    - tendon rupture
    - muscle pain (rhabdomyolysis – a potentially fatal, rapid muscle wasting ADR which may include dark or pink urine)

    Cardiovascular System:
    - torsedes de pointes (a fatal arrhythmia)
    - heart attack
    - palpitations (irregular heartbeat)
    - bradycardia (slow heartbeat)
    - tachycardia (rapid heartbeat)

    Immune System:
    - anaphylactic reaction (potentially fatal allergic reaction)
    - Stevens-Johnson syndrome (potentially fatal autoimmune reaction where the immune system attacks the skin)

    Additional ADR’s:
    renal (kidney) failure
    liver failure (potentially fatal)
    DEATH

    and other numerous and potentially fatal adverse reactions….

    and the FDA has to get SUED by Public Citizen before issuing a warning….
    but the Black-Box warning is for tendon damage??

    Why hasn’t the media figured that one out yet??

    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??

    Previously HEALTHY and ACTIVE….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 an insult to those whose lives have been carelessly destroyed by those we trusted.

    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, misery and emotional turmoil.

    http://blog.garymoller.com/2008/03/my-doctor-has-poisoned-me-with.html

  3. Seena says:

    I am a 34 yrd old mother who took three doses of Levaquin 2 and a half months ago for a UTI. I stopped taking the medicine due to myalgia, neuropathy, extreme panic, joint and tendon pain, and so on and so on. I’m still experiencing the joint and tendon pain throughout my entire body. There has not been one day in the past 2 and a half months that I have not been in pain. Let me addd that the joint and tendon pain started one week AFTER I discontinued the drug.

    This is an overprescribed drug that in some people can cause long lasting symptoms. Other drugs should be given instead, leaving these antibiotics for last resort use only.

    Seena

  4. Leslea Bates says:

    Please allow me to paste my comments since there are so many sites running an article on quinolones black box warning. My point to physicians is important and is from a healthcare professional’s viewpoint. I am passionate to get the word out about quinolones and keep other people from being hurt and need to do it as efficiently as possible.
    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 http://www.fluoroquinolones.org .
    Thank you for your time.

  5. Db Cipro says:

    The fact that Cipro and quinolones can cause permanent, untreatable tendon damage as highlighted by the need for a black box warning, that leaves patients with crippling untreatable pain, is only the tip of the iceberg when it comes to the other severe and permanently disabling adverse reactions that Cipro and other quinolones can inflict. The product information sheets provided by quinolone manufacturers also fail to indicate that some individuals will suffer from multiple adverse reactions that will become permanent and untreatable. They list a wide variety of adverse reactions that would seriously impair anyone’s quality of life, including psychological, neurological side effects as well as physical, if one had to live with them for life. Some of these reactions can develop days, weeks or months after taking these pills as well, making if more difficult to identify the drugs as the culprit of the disease.

    I as well as numerous other individuals, who have tried to report these reactions to their physicians and the FDA, have been ‘ignored’ or ‘rebuffed’ by physicians. I have a ‘constellation’ of symptoms from taking Cipro in 2006 that do not respond to treatment. My permanent adverse reactions in addition to chronic tendinitis include tinnitus, hyperacusis, visual distortions and light sensitivity, smell and taste perversion, insomnia, anhedonia, chronic fatigue, anxiety and severe depression, loss of appetite, peripheral neuropathy, myoclonic muscle jerks, hypertension, hyperlipidemia, hypothyroid, brain fog, memory problems, constipation and 25 pounds of weight loss in addition to the muscular and degenerative bone issues. Tendonitis is a small part of the entire picture. If you find this hard to believe, check the ADR lists for Cipro and Levaquin. They’re all listed, but are considered “rare” reactions. Only tendon damage and peripheral neuropathy are indicated as possible permanent adverse reactions. What I and many others dispute is how “rarely” they occur, and we report that many of these adverse reactions cannot be treated and remain permanent long after taking the drugs. And when people report that they do occur to them after taking Cipro, or Levaquin, doctors are reticent to acknowledge they were caused by the drugs, especially if they develop in these ‘constellation’ of maladies. What’s worse is that these symptoms are not treatable in many.

  6. Ty Taylor says:

    I’m sorry but your incorrect when you state “the side effect is pretty darn rare”. The Fda numbers are misleading. They admit their method of collecting and storing data is in need of an overhaul. Public Citizen is actually trying to go over the data once again and figure the correct numbers of tendon damage. The clinical data coming from other counties are showing much higher rates of tendon ruptures and other life threatening side effects.
    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.

  7. Rick Radcliff says:

    I took avelox 3 plus years ago for a sinus infection, and three months later a barrage of ADRs hit me. Not connecting my condition to the use of a fluoroquinolone, I went around the med. establishment for 5 1/2 months looking for answers, none of which were forthcoming. The med. establishment does not look for ADRs to drugs in their diagnostic paradigm. And because they don’t, alot of people are being mis-diagnosed. ADRs to FQs mimic alot of conditions; sojgrens, arthritis, diabetes; the list goes on.

    These drugs are being abused by the medical community; they should not be given as a first line of defense against things like sinus infection or UTI.
    Also, doctors are not aware that they should not mix FQs with NSAIDS or steroids. God forbid we should tell anybody that and risk the patient not wanting the drug! The profit margin is the bottom line here, not the patients’ health and well-being. The FDA shares the responsibility for this negligence.

    The recent black box warning for tendon tears is very inadequate. The warning should be for ALL the FQ ADRs….neurological, GI, musculoskeletal, endocrinal, renal, liver, heart problems, etc.

    The other notable thing about these drugs is that the ADRs to FQs are often permanent. The warning to discontinue use and call your doctor is futile in that the damage has already been done by the time you get an ADR. Some people recover most of their lives back but it sometimes takes years.

    It’s time to get the word out regarding the danger of fluroquinolones before more people’s lives are ruined.

    Rick

  8. david fuller says:

    Though I had posted this on other sites dealing with this issue, it is still relevant to the discussion at hand and I would hope the host of this site would not take offense at me repeating it here:

    In addition to the recent “Black Box Warnings” as well as the European “Dear Doctor” issued by Bayer overseas back in February 2008 concerning Avelox, the European Medicines Agency has moved to severely restrict the use of Avelox (moxifloxacin), to wit:

    FRANKFURT, July 24 (Reuters) – The European Medicines Agency has recommended limiting the use of oral moxifloxacin-containing medicines after finalizing a review of the safety of the antibiotics, the agency said on Thursday.

    The European body (EMEA) said it had concluded that these drugs should only be prescribed for acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics cannot be used or have failed.

    “The agency also recommended strengthening the warnings for oral moxifloxacin medicines,” it said in a statement.

    Moxifloxacin, a fluoroquinolone antibiotic, is marketed by Bayer (BAYG.DE: Quote, Profile, Research) under its brand Avelox.

    At its July 2008 meeting, the agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of oral moxifloxacin medicines continued to outweigh its risks.

    However, due to safety concerns, mainly related to an increased risk of adverse hepatic reactions, it recommended restricting their use in these indications.

    The CHMP opinion will now be forwarded to the European Commission to apply to all oral moxifloxacin-containing medicines authorized in the European Union.

    Responding to the recommendation, Bayer said the review confirmed the positive benefit-risk profile of the drug.

    “We would welcome an EMEA assessment of other antibiotics used for treatment of these infections in a similar fashion in the interest of patient care,” said Kemal Malik, a member of Bayer HealthCare executive committee and chief medical officer.

    http://uk.reuters.com/article/governmentFilingsNews/idUKL2453307820080724

    Black Box Warnings, Dear Doctor Letters, restrictions place on the use of Avelox, thousands of patients responding to these articles claiming severe injuries from this class, hundreds if not thousands of adverse drug reaction forums with tens of thousands of members world wide, as well as more than fifty percent of these drugs removed from clinical practice, and last but not least the fact that Nalidixic Acid, upon which all these drugs are based is a listed cancer causing agent, I dare to ask: are we still to believe the following comment which can be found at the end of just about any article written about this class?

    ‘The fluoroquinolones as a class are generally well tolerated; most adverse effects are mild in severity, self-limited, and rarely result in treatment discontinuation…’

    Or are we to continue wonder if we are the only ones who have bothered to do any research on this class in the past twenty six years. For surely who ever would make such a claim has not.

    “Repeat a lie a thousand times and it becomes the truth …” – usually credited to Dr Joseph Goebbels, Propaganda Minister of the Third Reich. I now credit it to those medical researchers who continue to state how safe and effective this class of chemotherapuetic agents are. For they have repeated this lie a thousand times a thousand times. Rather odd coincident that they are both (Goebbels, and these medical researchers who state such blatant lies) members of the medical community.

  9. Paul Sax says:

    Very interesting perspective on quinolones.

    Perhaps with this information (and the new hypervirulent C diff), a more cautious approach to use of these (and other antibiotics) in situations where the indications are marginal will become more widespread.

  10. Rocky says:

    I think having a black box warning should be the first step in a total re-education program for doctors. When I was given ciprofloxin in January 2008 for a sinus infection, I had terrible side effects – tendon pain and stiffness being only the tip of the iceberg – which I promptly reported to my treating physician only to be told it couldn’t be caused by the meds. When I pointed out that the warning sheet from the pharmacy said tendon issues were a side effect and to immediately report this to my treating physician, the doctor just shrugged it off and told me my problems were not caused by the cipro. I am sure if I went back to that same doctor today with my continued tendon pains and tendon stiffness and with a copy of the black box warning, he wold still act as if this fq medication could never cause my issues. It is ridiculous how trained professionals act so completely clueless or brainwashed – you can choose which they are. So while I think the black box warning is a good baby step, I think the FDA has lots to do to straighten this fluoroquinolone nightmare up, because it is a nightmare that no one seems to want to deal with.

  11. david fuller says:

    Hal, I would not bet on it. Every doctor that I had presented such information to over the past decade while seeking treatment for my own injuries refused to even take the time to read it. I rather doubt that such an attitude has changed since then. I still get reports on a daily basis in which the treating physician denies any association regarding these reactions and the fluoroquinolones.

    The new hypervirulent C diff has clearly been associated with the scripting abuse found within the hospital enviorment with most cases being associated with the use of levaquin. But levaquin continues to be handed out like halloween candy. Being a realist I know full well that this current discussion taking place on various sites found on the Internet regarding the fluoroquinolones will change absolutely nothing. But I do feel better believing that I may have saved just one person from suffering as I have the past twenty five years by participating in them.

    The following is a prime example of what we face:

    Quinolones, Including Moxifloxacin HCl (Avelox), Linked to Risk for
    Phototoxicity
    On February 15, the FDA approved safety labeling revisions for
    moxifloxacin HCl tablets and moxifloxacin in sodium chloride
    injection (Avelox, Bayer Pharmaceuticals Corp) to warn of the risk
    for photosensitivity and phototoxicity associated with quinolone
    antibiotics.
    In addition to moderate to severe photosensitivity, the agency has
    received postmarketing reports of phototoxicity reactions that can
    manifest as exaggerated sunburn reactions such as burning, erythema,
    exudation, vesicles, blistering, and edema that involve areas exposed
    to light (eg, the face, “V” area of the neck, extensor surfaces of
    the forearms, and dorsa of the hands). These reactions can be
    associated with the use of quinolones after sun or ultraviolet light
    exposure.
    Excessive exposure to these sources of light should therefore be
    avoided, and treatment should be discontinued if photosensitivity or
    phototoxicity occurs.
    Patients should be advised to minimize or avoid exposure to natural
    or artificial sunlight (eg, tanning beds or ultraviolet A/B light
    treatment) while taking quinolones. Those who need to be outdoors
    during therapy should wear loose-fitting clothes that protect skin
    from sun exposure and adopt other sun protection measures such as
    sunscreen if possible.
    Moxifloxacin is a broad-spectrum fluoroquinolone antimicrobial agent
    indicated for use in adults to treat infections caused by susceptible
    strains of designated microorganisms. Indications include acute
    bacterial sinusitis, acute bacterial exacerbation of chronic
    bronchitis, community-acquired pneumonia, uncomplicated and
    complicated skin or skin structure infections, and complicated
    intraabdominal infections.

    Comment:
    This came out right after the European Dear Doctor Letter (concerning Avelox). Somehow this fails to convey the information found within this Dear Doctor Letter.

    Let us take a moment and compare the two warnings:

    The FDA’s version:
    Those who need to be outdoors during therapy should wear loose-
    fitting clothes that protect skin from sun exposure and adopt other
    sun protection measures such as sunscreen if possible.

    The European version:
    We would like to further remind you to be vigilant for the early
    signs and symptoms of severe liver injury and bullous skin reactions
    like SJS or TEN. Patients should be advised to stop treatment
    immediately and to contact a physician if relevant signs or symptoms
    occur, including rapidly developing asthenia associated with
    jaundice, dark urine, bleeding tendency and hepatic encephalopathy.
    When prescribing moxifloxacin, consideration should be given to
    official guidance on the appropriate use of antibacterial agents
    which is especially relevant with regard to treatment of less severe
    infections.

    Even when the FDA is aware of problems, the drug continues down the road to approval. For example based on the CHMP review of the safety and efficacy data the the European Medicines Agency decided that the application for Garenoxacin 400 mg tablet was NOT approvable for the treatment of community acquired pneumonia (CAP) in hospitalized patients, for acute exacerbation of chronic bronchitis (AECB) or for uncomplicated skin and soft tissue infections (USSTI). The application for
    Garenoxacin 600 mg tablet was NOT approvable for the treatment of
    complicated skin and soft tissue infections (CSSTI) or for intra-
    abdominal infections (IAI) and acute pelvic infections. The
    application for Garenoxacin 2mg/ml solution for infusion was NOT
    approvable for the treatment of CAP, CSSTI, IAI or acute pelvic
    infections. The major objection precluding a recommendation for
    marketing authorization pertains to deficiencies on the efficacy
    demonstration as well as severe adverse drug reactions.

    Yet the FDA had no such reservations and was ready to continue the approval process until the applicant withdrew their application.

    Just like we saw with Factive, which is associated with disfiquring rashes, the only difference being that the applicant did not withdraw their application here in the States. Europe turned it down, the FDA approved it. Now we have patients with disfiquring rashes and treating physicians denying that the drug is responsible.

    Yet again the FDA bested by a ‘chimp’.

    Here is another example:

    EMEA Restricts Use of Oral Norfloxacin Drugs in UTIs
    LONDON — July 24, 2008 — The European Medicines Agency has
    recommended restricting the use of oral norfloxacin-containing
    medicines in urinary infections.

    The Agency’s Committee for Medicinal Products for Human Use (CHMP)
    has concluded that the marketing authorisations for oral norfloxacin-
    containing medicines, when used in the treatment of acute or chronic
    complicated pyelonephritis, should be withdrawn because the benefits
    of these medicines do not outweigh their risks in this indication.

    This is based on the fact that the efficacy has not been adequately
    demonstrated for this type of infection.

    The CHMP review of norfloxacin medicines was initiated on the request
    of the Belgian medicines regulatory agency. They questioned the
    efficacy of oral formulations of the medicine for complicated
    pyelonephritis in comparison with other fluoroquinolones.

    Following evaluation of information provided by the companies, the
    CHMP, at its July 2008 meeting, noted that there was not enough
    clinical data to demonstrate the efficacy of oral treatment with
    norfloxacin-containing medicines in complicated pyelonephritis.

    Therefore, the CHMP concluded that the use of oral norfloxacin-
    containing medicines in the treatment of acute or chronic complicated
    pyelonephritis could no longer be supported.

    The recommendation of the CHMP does not have an impact on the use of
    oral norfloxacin-containing medicines in other types of infection.

    Doctors should not prescribe oral norfloxacin for complicated
    pyelonephritis and should consider switching patients already taking
    oral norfloxacin for this type of infection to an alternative
    antibiotic.

    Comment:

    I am more than willing to bet the farm that you will not see the FDA taking such action here in the States or the treating physicians following this recomendation. You would be surprised at how often I have bet the farm over the years and I continue to live on it.

    I could go on forever citing such examples, but I will spare you from having to read them all. The best I can figure it would take you about four months, reading eight hours a day, every day, to read the mass of data that I have accumulated that documents the true safety profile of this class. Having read this data myself I know how time consuming it would be. But then again I was able to spread this over eight years rather than four months.

    Though I can be quite sarcastic, or even caustic regarding these issues, I truly appreciate your open mindedness regarding these issues. Your peers would do well to follow such an outstanding example that you have set here. I thank you for allowing this discussion to even take place. You have no idea how many patients you have rescuded from a life of misery by doing so. And for this I thank you from the bottom of my heart.

  12. Levarel says:

    Because there are so many websites running stories on the addition of a black box warning to the fluoroquinolone class of antibiotics , I’m copying this post verbatim to as many of them as I can in order to share my experiences and what I feel is valuable information. It is my sincere hope that by doing so I can prevent others from ending up in my situation and I hope that the owner of the site understands and allows me this opportunity.

    I was 23 years old. My life was ahead of me and I was looking forward to it. I came down with simple, acute cases of bronchitis and sinusitis and was given 20 days of Levaquin as treatment. My life has never been the same.

    I’m almost 27 now and have spent the last 3 1/2 years completely disabled and housebound. The list of adverse reactions I’ve experienced is too long to really post here, but includes severe non-abating tendon problems in every part of my body; muscle contractures; severe fatigue, depersonalization and short-term memory loss; peripheral neuropathy; circulation problems; gastrointestinal problems; anxiety with random, uncontrollable panic attacks; and some neurological symptoms that no one has been able to even diagnose. I was mostly unable to stand up for over a year due to severe problems with my ankles, knees and hips and can still only walk very short distances; I also require speech-recognition software to type and any sort of even mildly strenuous activity results in further injury.

    Every doctor I’ve seen has concurred that Levaquin caused this, but none have been able to help me at all, despite the warning label on the drug saying to contact your doctor if you experience any of these symptoms. No one in the medical community can give me any idea of what my prospects for recovery are, nor can they can tell me what effect this ordeal will have on my health as I age.

    While the full prescribing information lists nearly all of my symptoms as possibilities, it does not warn that they can last for years or even be permanent, that adverse reactions tend to appear in groups (many people report dozens of symptoms), and that such severe side-effects can appear weeks or months after the drug has been discontinued. The brunt of my reaction started approximately two weeks after I completed my course of Levaquin, worsened in many respects for well over a year and continues to this day. The vast majority of people who are prescribed these drugs assume that any side-effects experienced will resolve when the drug is discontinued and warnings that this is not the case are required immediately in order to provide some semblance of informed consent. The current situation is resulting in large numbers of people who are injured by this class of drugs, but have yet to uncover the cause of their ailments due to the delayed nature of these reactions.

    Over the years, I’ve corresponded with hundreds of victims of these drugs, all with stories eerily similar to my own, and read thousands of such testimonials on the various websites devoted to these reactions. While these may be anecdotal reports, the correlations between them, the sheer number available and the severity of what is being reported more than warrant a thorough investigation into this matter. Informed consent is never too much to ask for and the least that should be given when it comes to a person’s health.

    This black box warning, while a step in the right direction, does little to prevent others from ending up like me and nothing at all to help those who are already here. The FDA has dropped the ball on this one (to put it nicely) and I can only hope that someone in either the medical or journalistic communities decides to pick it up again. No one deserves to have to go through what I have and especially not for infections that most likely would have cleared up on their own with some time, rest and increased fluid intake.

  13. david fuller says:

    I recieved these two desperate emails within the past week. If such reactions are to be considered ‘rare’ this would be statistically improbable. What is ‘rare’ however, as one can see by these reports, is anyone in the medical field associating such reactions with the fluoroquinolones even though they have been stated as such for two and one half decades:

    First case:

    “I am writing on behalf of my brother and sister-in-law, a vital 32-year-old mother of 2 who is in dire condition after having taken Cipro for a post surgical uterine infection. She is suffering a whole slew of neurological and vision symptoms, is unable to open her eyes, is confined to a wheelchair and needs nursing assistance in their home…None of the many, many doctors she has seen believe the Cipro to be the cause of her problems and none are doing anything to treat her…”

    Second case:

    My wife took Cipro once on July 3rd and again on July 4th this year. After the second dose she had a very severe cardiac reaction with chest pain and pressure, arm pain, lightheadedness, and heart palpitations leading to her blacking out. She was taken by ambulance to the ER. All of the cardiac tests indicated that she did not have a heart attack. However, she was admitted for observation. The next day she had another set of cardiac symptoms followed by pronounced facial drooping and left side muscle weakness/partial paralysis. These symptoms looked like stroke symptoms but MRIs and other tests ruled out a stroke. After four days and numerous tests, the hospital staff concluded that Cipro was the likely culprit. However, the problems did not end after her discharge.”

    “The left side weakness persisted after that and she continued to get physical therapy and additional out-patient tests to rule out degenerative conditions such as MS and myothenia gravas. After two weeks, the left side weakness was joined by arm tremors a la Parkinson’s and blurry vision. Then, last weak, she began to have frequent violent seizures intermixed with lengthy periods of trembling/shaking. Her eyelids forcibly snapped shut and her eyes rolled up into her head for hours on end. At times, she also lost the ability to speak. As this progressed, she was given several anti-seizure medications to little avail. We checked her back into Georgetown University hospital this past weekend (where they have a movement disorder clinic) and she underwent a continuous 24-hour video EEG. The conclusion of the neurologists there, however, was that this is all psychogenic non-epileptic seizure disorder (PNES) which is very unsatsifying. They are simply unwilling to consider that this is all due to the Cipro.”

    And I get such emails every day of the week for the past decade. Rare? NO. The only thing rare about these reactions is anyone in the medical community having a clue or any viable treatment options to offer when they do.

  14. Bob says:

    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!!!!!!!!!!!

  15. Cynthia in Texas says:

    I was given Cipro for 5 days for a UTI. I took it the week before Mothers Day 2008. I woke up Sunday which was Mothers Day with spasms in left thigh,knee and hip pain.Today is Jan.20,2009 and I have 20% atrophy of left thigh, still have muscle spasms,difficulty walking,can’t work. I have numbness of left thigh and when it goes numb I can’t walk long because picking that leg up to walk is like lifting dead weight. I give out. When this all started I didn’t walk for 3 months except to rest room and then back to sofa or bed. I now walk a block daily with my dog but am very slow and worn out when I return home. I no longer drive or go shopping,etc. I go to church on Sunday morning with my husband and then I am done in for the day and have to go to bed. I am 58 years old and was in good health until this happened. I have been through 5 doctors who tell me I have Periperal Neuropathy and that Cipro would not do this. All that they do is offer me Hydrocodone for pain. I am at my wits end and feel like my life is at a standstill. I would never ever recommend anyone to take a flox drug under any circumstances.

  16. [...] HIV and ID Observations Floxins and the black box warning Posted by root 15 minutes ago (http://blogs.jwatch.org) I 39 m still experiencing the joint and tendon pain throughout my entire body the tendonitis was so painful that walking was more like hobbling comment this came out right after the european dear doctor letter concerning avelox powered by wordpress using Discuss  |  Bury |  News | HIV and ID Observations Floxins and the black box warning [...]

  17. jon mulder says:

    wife died after taking two doses of levaquin after first episode with the drug caused hives, cause numerous strokes and then death, advise anyone you love to never take levaquin or any quinolones

  18. Eduardo says:

    I have taken levaquin in 2010 and guess what? It worked perfectly well, and I have been able to run, work out and carry a perfectly normal life ever since.
    My 79-year old dad has taken moxifloxacin twice in the last year for respiratory infections and guess what? He’s fine, thanks! He walks to his office everyday, makes jokes, drinks whisky eventually.
    Beware of notority bias, guys.

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