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Cipro joins the 'black box' club

July 8, 2008 |  4:11 pm

Cipro The club may not be as elite as it once was -- or perhaps, in an ideal world, should be -- but the Food and Drug Administration has decided Cipro and its ilk deserve to be members.

As such, the class of antibiotics known as fluoroquinolones will now bear a boxed warning, also known as a "black box," because of reports that the drugs increase the risk of tendinitis and tendon rupture. The FDA has told the manufacturers that the label, the agency's most serious warning, is necessary to ensure that the drugs' benefits outweigh the risks. Always a good thing. It's also told them, while they're at it, to throw in a medication guide to inform patients of potential side effects.

Most people may remember the drugs from their heady days as simply-must-have protection against a potential anthrax attack. But we've all grown older and wiser and less panicked and are now more worried about simply being able to move about the house without hurting something. Says the FDA's release: "The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart and lung transplant recipients."

The prescribing information already includes warnings about the potential problem, but sifting through that material isn't easy even for professionals. They're busy, you understand. And besides, there's just something about that black box label that tends to give prescribers -- and prescribees -- pause.

If you've had problems with the drugs (or any drugs), you can offer your two cents at MedWatch, a more user-friendly way of referring to the FDA Safety Information and Adverse Event Reporting Program.  Otherwise, how will anyone know?

For an easy-to-read list of other drugs with black box warnings, go to FormWeb. The information is easier to find than on the government site.

-- Tami Dennis

Photo: When anthrax was discovered at a New York mail processing facility in 2001, workers there were given Cipro as a precautionary measure. Other Americans soon wanted it too.

Credit: Gary Friedman / Los Angeles Times

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Comments (97)

I take cirprofloxacin only when I have bladder infections! Which is about twice a year... do I have any concerns about tendonitis or tendon rupture...
please let me know!!

I took Levaquin after becoming ill while living out of the country. In just one moment, I went from a healthy 26-year-old that was realizing my dream and beginning a fulfilling career to someone that I can longer recognize. I have suffered peripheral neuropathy, heart damage, collagen damage, neverending muscle pain, and tendonitis in all of the major tendons of my body, and this only represents a fraction of the side effects that I have experienced. I have lost everything and I am completely disabled. I urge those that claim that these drugs side effects are rare or harmless to do the research and inform themselves. I never have suffered an adverse effect from other medications. These "antibiotics" are not safe under any circumstance and have the potential for longlasting harm and that is not acceptable. In clinical trials for these medications, many side effects were not reported and claims of severe symptoms were often discredited by pharmaceutical company-funded researchers because it was not what they wanted to see. It is an unbelievable crime against the population and I am glad that a glimmer of the truth is being shown. I took my health seriously but I foolishly trusted in the system. Doctors are not infallible. I am glad that a black box warning is now being placed on these medications and hope that many will heed their warning so as not to suffer as I have.

My tendons still are sore from taking cipro for only two days. Sometimes I feel better, think I am cured and do something stupid like eating beef or bacon.

Most of the meat produced in this country is tainted with similar antibiotics. In fact one study estimates that 84% of samonella is resistant to at least one anti-samonella antibiotic. We use 8 times more antibiotics in our food than are prescribed to humans!

Food for thought.

I was assured by my Dr. that Cipro is completely safe when he wrote me a script for a suspected UTI 2 years ago. I took it as directed for the 10 days and on the last day it felt like my whole body started to fall apart. I have severe insomnia, nerve pain in my feet and legs. Joint pain in knees, hips and shoulders and all kinds of CNS problems. I had none of these problems and was a healthy and happy 51 y/o male until I took Cipro 2 years ago. My life has been destroyed along with my health and finances by this drug Cipro. I have been to at least 6 different Dr's and none will admit that Cipro could be responsible for all my ailments. This has been a living nightmare for 2 yrs, with no end in sight yet. I don't feel like I'm improving at all. I wonder what the internal damages are from cipro and if I will even live much longer now.

This class of abx is a lot more toxic and harmful than the makers and Dr's are telling us. The FDA has not done their job of making sure these drugs are safe.
The percentage of severe ADR's is much higher than what they are telling us.

It would have been nice for the FDA not to have taken 2 years to come to this conclusion.

Perhaps I could have avoided the 6 months of joint pain & neuropathy I've been in since I stopped taking Levaquin.

Its pretty amazing how many people have been affected by these drugs and just how long it took for this to get recognized, just look at the comments here.

My adult daughter was given Cipro for pinkeye. After a few days she started bleeding from her rectim. I brought her to the hospital where she was admitted. The doctor ran numerous tests and continued the Cipro along with IV potasium of which she was dangerously low. After each pill of Cipro, my daughter told the nurse she felt like her blood was on fire. She developed a rash on her back which the doctor said was heat rash. When she started screaming that she didn't want to take the Cipro any longer because she felt it was causing the fire sensation the doctor and nurse said she was having panic attacks. They gave her anxiety medicine and the Cipro again. The rash then broke out on her stomach which proved it wasn't heat rash from laying down so long in the bed. I demanded that she be given benedril to see if the Cipro was causing the fire sensation. The benedril worked. Four hours later the nurse came back with the next dose of Cipro. My daughter refused it. The nurse was angry and scolded her. My daughters pulse for those few days was dangerously low. This was 5 years ago. My daughter has had fibromyalgia since that time. The pain is so severe that she has to be on Oxycodone 10mg, and 50 mg Duragesic patches every day. She KNEW she had an algeric reaction to the Cipro and she insists the fibromyalgia was caused by it. She is completely disabled and spends most of the day in bed. This drug has ruined her life.

There are thousands of people crippled by Cipro and other fluoroquinilones. For those who need to find out more information and suffered serious ADR from CIPRO, it is worth visiting www.favc.info

I don't understand where they hippocratic oath went? The scientists and doctors that are developing and prescribing the quinolones aren't following the oath, obviously. How can someone of obvious intelligence (graduated medical or pharmaceutical school) ignore the real statistics? How can they continue to give out quinolones unnecessarily. Other antibiotics work just as well on numerous infections. Less dangerous antibiotics.
MRSA for example is resistance to quinlones, the antibiotic of choice is Bactrim (Trimeth/Sulfa). Physicians need to look at their hosptial's antibiograms and prescribe the least toxic and least expensive antibiotic that is effective. Please quit letting pharmaceutical kick backs and ego stroking by them keep you from doing what is best for your patients.
The pharmaceutical companies are out to make money, doctors are supposed to be about healing, all this damage can stop with the pen strokes that physicians apply to their prescription pads.
The medical community needs to take it's intelligence and use it with some common sense and sense of decency and accountability for the patients they serve. Quit writing prescriptions for quinlones, using quinolones routinely in the surgery suite when there are other drugs that are just as effective.
If other antibiotics are not working and it is a matter of life or death for the patient, maybe quinolones would be a last resort answer, but only in those instances. You wouldn't give Vancomycin routinely, it is only used as a last resort, quinolones are also toxic and should be treated as such.
I am a part of this community and advocate diligently against the routine use of quinolones, I am accountable for my part in a patient's care and take if very seriously. I would never unnecessarily put anyone in harm's way and I haven't taken an oath not to do so. My conscience takes care of that.
Even if I wasn't one of the multitude of sufferers that have had their lives changed forerver due to the quinolones I could not in good conscience ignore the damage quinolones are doing. Because I am a part of the medical community I do my best to inform the medical staff at my facility of the dangers of quinolones, I recommend safe alternatives by referencing an antibiogram.
It's not that difficult to step up and do what's right.
Physicians please join me and make your pen strokes honor your oath.

I agree with David Fuller. Cipro has turned me into a literal invalid. I was given it several times over a 5 year period for UTIs. I have had close to 30 symptoms over the years. Not one health practitioner and that includes holistic health practitioners such as chiropractors, acupuncturists, etc even mentioned that my problems might be due to Cipro. In fact, they considered me to be a mental case for even suggesting it. Leaving this dangerous class of drugs on the market is both deceiving and immoral. When will we learn that profits aren't all that count? The problems with these drugs have been know for years. Why do physicians pass out "free samples" like candy? Do they somehow benefit from this too?

I wasn't sure if I should post here not because my life hasn't been destroyed by the fqs (it has) but because I think the black box warning will do nothing to stop this madness spreading. For whoever wants to read my story or other people's stories to see in what danger you put yourself into by taking anything which finishes in -floxacin or their antimalarial cousin Mefloquine here is the link:
http://noquinolones.proboards58.com/index.cgi?board=stories

What about otic formulations of cipro?

I recently completed a course of Cipro and just as it ended, I discovered veins prominently appearing on my hands, inner arms, all over my torso, and to a lesser degree on my legs. My doctor, who has never seen this effect with the drug before, believes it is an allergic reaction that should resolve within weeks.

Has anyone else seen this reaction?

Under the circumstances the black box warning sounds like a good idea, and perhaps the FDA should take a longer, closer look at this family of drugs.

Wow -- just went to the doctor today and was prescribed Avelox (in the same class as Cipro) for a sinus infection. Said that until they got the culture back and knew what bacteria I've got to just start taking the Avelox. I took one pill this morning -- and my sinuses are already starting to feel better -- but now -- after reading all of these horror stories -- I'm not going to take another pill. Unbelievable. My heart goes out to all of you who have been injured by these "medicines"

I only hope that Bryan doesn't have to endure the pain I am experience after taking the antibiotic. Chronic fatigue, fingers lock up, veins all over my legs, hips and shoulders in constant pain, can't sleep because of the vivid dreams keeping me awake at night along with the pain, can't walk without pain. All this happened after I took the medication. I stopped taking it immediately, didn't need a doctor to tell me something was wrong. I question everything and if I don't get answers to my questions, I find another doctor.

My sister-in-law had her doctor tell her that her pain was all in her head after he needlessly removed her uterus because he said that needed to be removed but the pain still continued. He never checked for kidney stones and that was the source of her pain.

My mother was told by her diabetes specialist that her pain was because she was just old and she was imaging things. The pain was so unbearable one night she ended up in the hospital only to be told by her oncologist that she had lymphoma and she was in the fourth stage, fifth being terminal. She also told the original doctor she felt she had a stroke and he laughed it off. Her neurologist confirmed her stroke.

My husband and I went to a new doctor, I saw her first. When I met her she asked me how I was doing since she saw me last (she was looking at a chart and assumed I was that person). I told her I had never seen her before. She argued with me until I told her to check the name on the folder. She had someone elses folder, never apologized for her error. My husband asked her when he saw her for a stress test because he just wasn't feeling right. Numbness in his fingers, pain down his arm, shortness of breath. She wouldn't order one because she said he was too young and she was the one that went to medical school. Two weeks later he had two stints put in his heart after his heart attack.

Doctors are only human and they do make mistakes, but they need to listen to their patients. When the almighty dollar interfers with their judgement and they rush to their next patient so they can make more money in volume, they should give up their practice. Bryan must be related to the doctor that told my husband she was the one with the medical degree, he is as arrogant as she was.

In late 2001, at forty years of age, I was prescribed Cipro as a possible treatment for irritable bowl syndrome, a less than serious condition. Shortly after taking the drug, I had experienced (and am progressively still suffering from) the following: Profound unilateral hearing loss and tinnitus (diagnosed as a perilymphatic fistula), severe peripheral neuropathy, chronic tendon pain (tendonitis), muscle wasting, pain and spasms. To this day, I find that I am having increasing difficulty walking, and am concerned that I will soon be completely disabled due to the progression of these conditions.

I was never warned about these apparently prevalent, permanent and debilitating side effects prior to taking Cipro. If I were, I would have NEVER considered taking it.

I don’t believe that this drug should be administered in anything less than a life-threatening situation, and should be marketed as such. Apparently, people continue to be seriously injured unnecessarily as a result of taking this drug, in situations where safer antibiotics might have been used. The general public (as well as most doctors) seem to be completely ignorant as to the high incidence of debilitating adverse effects that this drug continues to inflict on unwitting recipients. In my opinion, this class of drug posses an unprecedented risk to public health and safety. This insanity must end, now!

Diverticulitis is a fairly common infection situation among older people, and it is life-threatening with in a week or so. Cipro is an antibiotic that is usually available over the counter in many foreign countries and is very effective. When that situation occurs (diverticulitis), it needs to be treated *right away*. One just has to take the chance on possible side effects if one wants to keep on living.

Charles,
Diverticulitis also responds very well to metronidazole (Flagyl),
cephalexin (Keflex), and doxycycline (Vibramycin). One does not have to risk being crippled for life to treat this common disease. The fluoroquinolones are NOT the only drug available for every disease state that they are prescribed for. There any number of other drugs with a much safer safety profile to choose from that result in the same outcome without such debilating side effects.

Why isn't our congress forcing a mandatory investigation into what is happening to those of us who have sustained these ongoing painful and disabling reactions that impact multiple body systems.. Many do not just have tendon issues but have tendon issues accompanied by peripheral neuropathy, muscle, joint, ocular, vestibular, cns and other systemic impact.

Why is it that when a Pharmaceutical company issues a warning about their drug in one country the warning is not mandated to be worldwide to warn all physicians and patients.

In 1996 Pubic Citizen Org. petitioned FDA to issue DEAR DOCTOR LETTERS about the Fluoroquinolones tendon issues.
At that time their petition included information that concomitant steroid warnings increased such risks. NO Dear doctor letters were issued and Concomitant steroid warnings were not warned about on labeling of the drugs at that time.. Although this was known in 1996 Levaquin did not receive a concomitant steroid warning until 2001, and Cipro received a steroid concomitant warning much later then that.

In December 2001 , President of the Postal Union Urged congress to study the medical effects of Cipro
on Postal Workers following Anthrax scare at the time where Cipro was being administered to Postal workers.

Ministry of Health France 2001 and Ministry of Italy 2002 issued DEAR DOCTOR letters for Levaquin why didn't the FDA warn in the USA by issuing DEAR DOCTOR LETTERS.

In January 2002 the Irish Medicines Board Drug Safety Newsletter –
January 2002 - Issue No.14 The Pharmacovigilance Unit states " Levofloxacin (Tavanic) " The Company responsible for marketing the above product in Ireland have agreed to undertake an
epidemiological study to further investigate the risks associated
with development of tendon disorders." Where is the study and what was the outcome?

In 2002 Montana Democrat Sen. Max Baucus wrote to the
General Accounting Office to ask for an investigation regarding Cipro because one
of his staff suffered a debilitating reaction and still remains disabled today.
Where is the investigation?

In 2005 Attorney General for the State of Illinois petitioned FDA calling for an investigation when their constituents who took Levaquin sustained injuries- calling for stronger warnings and investigation of this drug and the class of drugs known as Fluoroquinolones.

FDA issued a response saying they required more time but indicated no deadline time. FDA had already been petitioned in this same regard in 1996.

In 2006 both the attorney general of Illinois and Public citizen org petitioned FDA regarding warnings again.
FDA did not respond in the legal timeframe required for petitions to be answered and a lawsuit was brought against FDA by Public Citizen.

In February 2008 "Dear Doctor" Letters for the Fluoroquinolone Avelox / Avalox Sent By Bayer In Europe, did Bayer or FDA forget to send DEAR DOCTOR letters in USA? when do they plan on issuing the same DEAR doctor letter to warn in the USA that Avelox may lead to potentially fatal liver damage and skin disease as they have in Europe.

And how about an epidemiological study to determine why so many people are having these systemic reactions effecting multiple body systems that are leaving them in chronic pain and disabled.

Why doesn't the National Institutes of Health do research on patients who have sustained reactions to Fluoroquinolones.

5 fluoroquinolones have already been removed off the market in a short time due to safety issues.


Physicians and Patients must be warned not just about impact on tendons but the systemic problems so many patients
are sustaining that impact not only their tendons but impact their joints, muscles, peripheral nervous system ( peripheral neuropathy) ocular issues, vestibular,and central nervous system.

When the majority of prescribers are not familiar with such risks, do not believe patients reporting such reactions, and deny that they occur more people will continue to be injured when a majority of these reactions could be prevented by proper warnings and education and appropriate prescribing.

In writing to FDA regarding concerns about these issues their response was to say they have no jurisdiction over how doctors prescribe once something is
approved. Yet they are fully aware of how frequently these drugs are being inappropriately presecribed and what is happeing to patients by reports seen in their own adverse reporting Database. It is stated in media pieces that they did their own new analysis on reactions but have failed to disclose the numbers publically in media pieces?


I took Cipro for a bladder infection about 2 years ago. Shortly after my knee became inflamed and I continue to have swelling on the knee and stiffness.
I was never warned of any of these side effects, and or the extent of the concern with this classification of drug. Even the product insert from the pharmacy minimizes the conern. Until reading this alert today I had no idea that my knee pain could be associated witht the medications I took.

I agree with Fuller and others, this classification of drugs should be a last course of treament and reserved for life threatening issues.

I could have stopped my cipro on the first dose because my tendons started to feel a bit weird then, including my joints. I asked the doctor and he suggested it was anxiety related. If this side effect was taken more seriously maybe I could have been spared 9 months of hell!?

I took Levaquin in October of 2006. I did not have tendon ruptures, but I did have joint and muscle pain and weakness. In December of 2006 I seperated my cervical spine from my cranium just from stretching one morning.

I had a plethora of other symptoms, some of which left me bedridden for 4 1/2 months. I had anxiety, sleep problems, nerve attacks with which I would twitch, jerk, and yell out uncontrollably. I had orthostatic hypotension, palpitations, severe digestive problems, my endcocrine system got hit, spawning all sorts of problems like hypothyroid, hyperthyroid, hyperglycemia, hypoglycemia. (I had problems with these things before, but the Levaquin made them much worse.) I lost quite a bit of hair, suffered depression, and the list goes on.

This class of drugs is poison and nothing but. I am glad for the black box warning, for whatever reason the wretched FDA decided to call for it. I am given to understand that when a drug is ‘black-boxed’ doctors are far more likely to NOT prescribe it. I certainly hope this is true.

E.

I took Avelox, another fluoroquinolone antibiotcic in 2004. I had immediate, severe pain in legs, arms, hands , back, chest wall. I had tremors and fasciliations, anxiety, insomnia, and then a couple of months into the reaction, I had the horrendous burning pain that sent me twice to the ER looking for relief. My doctor didn't believe that I was having an adverse event to the drug so he sent me for a myriad of tests to rule out MS, Lyme, Lupus, heart problems, rare tropical diseases, you name it! Thousands of dollars worth of tests, MRI's, CAT scans. And not ONE doctor would admit that I had a reaction to a fluoroquinolone. Finally, a neurologist a Yale University hospital said that he had seen this before but he was at a loss to treat it. He only treated the pain with vicodin and the anxiety with ativan. Later my doc prescribed Cymbalta for the peripheral neuropathy. But what DID this Avelox do to my body? Where are the studies to find out the exact damage done to us and how to remedy it? We are forgotten by the FDA and the pharmaceuticals. There is a cash cow here. They just want us to go away! But I for one don't intend to do that.
Had Peripheral neuropathy and Central nervous system damage been mentioned in a nice little black box on my Avelox script, I might have been able to make an informed decision. More than likely, I would not have taken that drug. And I'd still be out working out at the gym, doing my work with ease, and going on with my life.
Instead, I have permanent short term memory loss, peripheral pain in my hands and legs, and a body that has a compromised constitution. I need excessive amounts of sleep after even very basic daily tasks.
I have faired much better than many that have been affected by this class of drug and I am so grateful for the amount of function that I have. But I will do anything to keep another unwitting soul from ending up like me.
Sally

Tendon damage is the least of your worries!! FLUOROQUINOLONES such as CIPRO, LEVAQUIN, AVELOX (and more), are TOXIC chemotherapeutic agents commonly prescribed by doctors as "antibiotics".

The adverse-reactions caused by these drugs are NOT mere side-effects!!
They are a direct result of our DNA being damaged by the TOXINS in these drugs, leaving us with SEVERE, often PERMANENT, DISABLING damage, not only to the tendons, but also muscle, joint and cartilage...central nervous system, our heart and respiratory system...skin, liver, kidneys--
EVERY organ in the body--even DEATH!!

THE LITTLE BLACK-BOX IS NOT ENOUGH!!

Previously HEALTHY, ACTIVE mom of twin boys--20 pills of AVELOX and LEVAQUIN, 2003, completely interrupted my life, causing horrendous physical suffering and emotional anguish!!

Progressive chronic pain, tendinitis.....heart-palpitations.....bleeding skin.....
vibrations throughout my body.....neuralgias and myalgias......
anxiety and depression....ringing in the ears......the list is endless!!

Many people are being MISdiagnosed w/ fibromyalgia or chronic fatigue, and more, as these reactions can be DELAYED!!

Fluoroquinolones are a DEATH-SENTENCE!!


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


~Shells~
AVELOX/LEVAQUIN 2003


I think it's great to see more publicity about drug 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).

While I suppose that it is tempting to cling to the naïve belief that all pharmaceutical manufacturers truly have the patient’s best interest in mind and are in the service of advancing the sacrosanct “Western medicine;” that illusion clearly crumbles when examining the fluoroquinolones. The assertion that fluoroquinolones are relatively safe or well-tolerated is based on the industry-funded clinical trials and journal articles that employ some of the most obviously flawed analytical techniques I’ve ever seen. Why is it that nearly every European published article that addresses the safety of fluorquinolones recognizes serious cause for alarm, and yet American (i.e. industry-funded) studies almost invariably find these drugs to be safe enough for babies…(just kidding, the pediatric trials are underway now and haven’t been approved just yet). Cipro is a second-generation fluoroquinolone, of which 38% have been recalled from the market for serious safety issues. Levaquin is a third-generation FQ, of which 63% have been recalled from the market for safety issues (including that nagging side-effect of death). 71% of the fourth-generation FQ’s have been recalled to date and it would be a safe bet to forecast that going higher.

There’s quite a bit of a snow-job going on here as well. The medical industry and pharmaceutical companies affected love to keep the warning and subsequent discussion strictly isolated to tendon rupture. They’re quite happy for you not to know about QT elongation, hepatoxicity, Stevens-Johnson syndrome, severe dermatologic reactions, myalgia, arthralgia, or any one of the many side effects that are listed as warnings on the patient information (but only after being amended due to so many patient complaints). Furthermore, the notion that “tendon rupture” is by itself a symptom, as opposed to being a manifestation of a systemic attack perpetrated by these drugs against the body’s soft tissue, is a logical fallacy of the highest degree. Why is there a correlation between tendon rupture and fluoroquinolones? Because FQ’s weaken tendons to the point that the tendons are more prone to rupture (and this has been clearly demonstrated by studies of human tendon cells exposed to FQ’s in vitro). Thus, just because a tendon has not ruptured, it does not mean that systemic damage has not occurred. Has the tread of your car tires not worn at all unless it blows out? I have witnessed first-hand the complete logical failure of a doctor who didn’t understand this concept and it amazes me that someone could make it through medical school and be so incapable of undertaking the simple logical operation it requires to understand that there is a mechanism of damage to tendon tissue that may be a real problem even without tendon rupture.

But remember people, trust whatever your doctor tells you, particularly when it involves drug safety…doctor’s mistakes and drug side-effects are only the third most common cause of death in the USA.

 


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