Cipro joins the 'black box' club

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

Comments

[Christine]

Here I sit over 25 months later from taking 4 750mg pills of Levaquin for a simple sinus infection. Here I sit in much pain with blurry vision. I've been in pain every day since day 3 of Levaquin. I wasn't given any warnings, just samples in my doctor's office, who, had been lied to by the drug reps about these fluoroquinolone drugs. I asked, "anything I need to know, any side effects"? "No" I was told, "these are great big-gun antibiotics". No, I have not had a tendon rupture but still have tendonitis in many parts of my body, my shoulder being so bad that my therapist is scared to work on it. My neck froze up 2 weeks ago leaving me screaming in pain and unable to drive. I suffered from severe insomnia, depression and thoughts of suicide, all drug related. I still suffer from many other ADRs including muscle twitching, nerve pain, osteoarthritis (never had this before Levaquin), floaters, gastro problems, liver problems, fuzzy vision, etc., etc., etc. My doctor has written "Levaquin toxicity" as my diagnosis. My neurologist agrees. This Black Box Warning is not strong enough! Tendon ruptures in people over 60 is just the tip of the iceburg! I was only 47 and very healthy when I took this drug. I did not take it with steriods. This drug has ruined my life! It has taken 2 years from me and God knows how many more it will take. These drugs should only be used as a last resort! Please stop hurting people!

[PV]

Man this drug is a killer. It literally changed the way i felt for my years in med school. I realized how incapable the medical community is l when it comes to treating such drug related side effects and problems, problems which sprouted after ingesting just two weeks of this poison.
This It is literally a poison. Spent 3 months in hospitals trying to figure out what was going in my brain. Doctors where between pseudotumor cerebri and massive cerebral vasoconstriction. I couldnt walk, breathe, sleep or do everyday activities just because of a two week antibiotic regime.

A previous sportsman and such an optimistic individual, participated 4 times a week in sport events, loved my studies and had such a great life now i foresee a future very far away from the past i had. And all this because of this drug and a slight prostatitis infection.

This is so extraordinary. So frustrating. I have tried everything after ingesting this drug to get better. From multivitamins for months, steroids, antidepressants, headache medication, nothing works. It just gets worse and worse. New sympoms arise from nowthere. At the margin of 3 months i started getting vision issues, lost peripheral vision and got flashes of light and so many dark spots in my vision, then found out my collagen was so damaged that even the most expert of doctors where astonished. 6 months out and i get issue with depression, concentration and headache just out of the blue. Spend thousands of dollars to find out that this nice drug had done such a damage to my HPTA axis, worse than receiving multiple anabolic drugs together. Thats what explains the confusion, headaches, intracranial pressure issues and depression, insomnia.

The list is endless. Damage to kidneys, spleen and on and on. Last but not least i feel my achilles tendons ready to break apart every time i walk and my hip /knee joints ready to fracture from the aches.

Lost my research job in the university, my family thinks i went nuts and i am home alone trying to fight out this nightmarish neverending drug effects.

THANKYOU BAYER
THANKYOU SO MUCH

[Db Cipro]

I have developed a ‘constellation’ of symptoms from taking Cipro in 2006 that do not respond to treatment. My permanent adverse reactions 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. I believe most of the weight loss is collagen and protein which would explain my muscle and bone weakness. The list continues. 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 after taking Cipro, or Levaquin, doctors are reticent to admit they were caused by the drugs, especially if they develop in these ‘constellation’ of maladies. But no one can explain why perfectly healthy people all of a sudden get seriously ill and crippled. When will the truth about these drugs be made known to the public?

[david fuller]

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.

[Paul]

It is now 3 years since i was put on a course of cipro for suspected prostatitis. I was told by my doctor that these drugs were totally safe (he gave me bigger warnings for relatively harmless anti inflammatories) and there should be no side effects. 3 years later my symptoms from taking cipro are still with me: unbelievable pain all over my body, severe fatigue whereby i cannot now walk 100 yards, severe digestive problems whereby i nearly starved last year, sever reactions to nearly everything including sunlight which leaves me in a lot of pain afte a few mins exposure and and even worse symptoms that have to be experienced to grasp like tremors, shakes, chronic migraines, insomnia etc.
These drugs should only be prescribed in a life or death situation and
organisations like the FDA have a lot to answer for due to their lack of screening of these drugs but the biggest culprits are the pharmaceutical companies who have knowingly withheld the true damage these drugs can cause. Despite the 1000's of submissions of people claiming to have been poisoned by these drugs they dont even acknowledge that it was possible to have these sort of symptoms from these drugs. Many ruined lives could have been prevented by stopping the course once the first sign of neurological symptoms began.

[Jane]

A dear friiend of mine took Cipro for a UTI, and has suffered with crippling joint pain and weakness ever since. She went to doctor after doctor, for months, taking in articles she was reading from the internet about Cipro possibly being the cause. Even doctors at Bethesda Naval Hospital and Walter Reed dismissed her concerns that Cipro was the cause. They wouldn't even look at the articles she took with her. They told her she had arthritis and to take Motrin. Now, this black box warning - finally! Have doctors been hushing this up, because they like to use Cipro to clear those nasty bacteria so quickly? Bryan, above, seems to want people to be silent if they've experienced these potentially life-altering side effects.

I have lupus, including joint pain, fevers, and other inflammation. I am highly allergic to many medications. Yet, yesterday, my doctor prescribed Cipro for my "fever of unknown origin", told me to fill the Rx, take it if the fever wasn't gone by tomorrow, and when I expressed my concern about Cipro, she said "That's very rare; it's a very safe drug.": I asked "What are we using it for, exactly? Do you know what infection is causing my fever?" And she said :"No, we don't know, you just tend to run fevers because you have an autoimmune dieease. This way, if you DO happen to have an infection in your colon, this will clear it up."
I haven't filled the Rx. Having read the new warning, there's no way I want to put this drug into my body "just in case" and end up sicker and in more pain than I already am.

Too risky to play around with, that's for sure.

[Pete]

What can I add ? My story is very similar to almost all those posting; but my symptoms have been mainly neurological. After 4 doses of Cipro, my heels began to hurt; I immediately stopped taking it, as I new something was up. 2 days later, I began to have heart palpitations, and neuropathy that climbed right up through legs and arms. My vision immediately changed, I forgot how to spell words, and felt like my head was disconnected from my body - a feeling like your drunk, but not. That was 1.5 years ago, and I still suffer from the neurological effects. Hope is running out that I may ever return to normal. After a lot of research, I learned how this drug smashes through the brain/blood barrier and corrupts at the DNA level. I would ask Bryan at the top of all these posts if he will feel the same way the day he becomes "collateral damage." ??? And all this for an infection I NEVER HAD. Not one doctor I saw believed Cipro could cause this, but we know better don't we Bryan ?

[Casey]

Took Cipro for two days 2 years ago and still have pain in my feet. Just got prescribed levequin and had no idea it was the same thing.....I have done 5 days and the doc just put me on 5 more but I have been hit with diareah and after reading this stuff will NOT be finishing this course and will be calling my doctor tomorrow. I hope the class action suit that will have to be coming for this crap bankrupts the company.

[Chris]

I've taken Cipro and now my life is a living Hell. I'm a 30 year old single male. I was perscribe Cipro for first time with a kidney infection. My joints hurts, my feet are so sore I can hardle walk. My knees hurt. I hurt all over so bad. It's all I can do to get out of bed in the morning. My back hurts and I ended up having back surgery to no avail. My hands swelled and I felt like my bones were broke. This was in 2002. This is now 2008 and I've still not recoveryed.. I'm not able to work and do the things I enjoyed (Riding Motorcycles). My life has changed forever due to taking Cipro. I'm home bound. I just make myself get up in the morning. This is my life now.

[bob]

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!!!!!!!!!!!

[clayton]

i have had difficulty with cipro. i took one pill and had bad leg pain and couldn't walk. i went to the ER and they of course said i was fine. i progressively got better and i notice that when i have body pain it is when i am stressed. stress makes my symptoms flare. i have had problems with anxiety before this and had symptoms like blurry vision, heart palpitations, floaters etc. they are all anxiety symptoms so don't blame them all on cipro. if you have an optimistic attitude it really helps. i noticed when i was depressed about it, it seemed a lot worse. lots of people have horrible diseases. you can't take back putting that pill in ur mouth so move on and make the best of it. im 22 years old and worked out every day. now i can't but im glad i can move my hands and feet...some can't. radically accept what is going on and you can have a happy full life! i do! i wish ya'll the best and things can and will get better. go to therapy and stop dwelling.

[jaime]

im taking cipro now it makes me so tired that i can't do much during the day i had to stop some of my meds cause i think they were interacting with it cause when i took it @ night for the second time i couldn't breathe i noticed i can't eat much on this medicine either i have bitter taste which makes it harder to eat but it's working for the uti it's only 3 days which tomorrow is last day so noticed i've been moody to but i always get that way was wondering if anyone gets moody from cipro?

[andy]

My main problem with the distribution of this drug is the lack of warning they give with the actual presciption. When I read the paper that came with Cipro BEFORE taking it, I did not find the severe symptoms that I experienced even under rare cases. Instead I found what I saw as some vague information on side effects that seemed common to many antibiotics. If they had mentioned what I and others REALLY experienced after taking Cipro even if it was listed as RARE, I most likely would have requested another medication from my doctor. I was NOT fairly WARNED! I ended up suffering many symptoms even after taking it for only 2 days including: severe bodily weakness, difficulty breathing, heaviness (including in the chest), vision change, heart fluttering and possible palpitations, bodily pain, anxiety/nervousness/restlessness, carpal tunnel pain, stiffness, bad mental confusion, difficulty concentrating, etc.. To sum it up, I felt that this medicine actually did damage to my body, whether it is temporary or permanent I do not know. I have not been off of it long, and hope to make a full recovery because I still do not feel right. I pray that there would be severe warnings included with this drug, and I'm not just talking about possible TENDON RUPTURE. THAT'S NOT ENOUGH! Then if people still want to take this drug with all of the warnings, then they at least have the proper information before taking the risk, unlike I did.

[ciproadv]

I took 10 days worth of cipro about 5 months ago. The treatment went quite well until about 3 weeks AFTER MY LAST DOSE. I started experiencing unrelenting anxiety, back pain, muscle weakness, and insomnia. I have never experienced any of these things before and had no idea what was going on until i did a bit of research. It turns out that many people (thousands of people and those are just the people who have posted their stories online, think of the many more who haven't) experience these exact reactions up to MONTHS AFTER taking quinolone antibiotics. Isn't that just insane, how are they still in my system? Since then I have experienced floaters develop in my eyes that will not go away, tendinitis in both Achilles, stiff joints that pop hundreds of times a day (even my sternum!), and sleep problems have not gotten better. I have only recently began to slowly work out again, but before Cipro i was very active and was in the best shape of my life (22yo). I can only assume that some people may react months later sometimes and never attribute these symptoms to Cipro, and are instead prescribed many more drugs to curb or stop their anxiety, insomnia and joint problems (what a sick world). I thought it was something that could never ever happen to me but it did and it makes you feel crazy when it does happen. These are potentially extremely dangerous drugs and should not be prescribed as nonchalantly as they are every day to people who don't need such potent antibiotics. Please be careful and ask your doctor for a non fluoroquinolone antibiotic if possible.

[Clayton]

So im back. It has been over 6 months since my Cipro problems with my tendons and the pain that most of us have had. The joint popping seems to be common and isn't harmful it can just be annoying so just get used to it b/c its not hurting anything unless u have major pain with the popping. A LOT OF THE SYMPTOMS THAT ARE BEING DESCRIBED ARE SYMPTOMS OF COMMON ANXIETY. i have suffered from anxiety my whole life and Cipro made it worse b/c you worry about your tendons rupturing and your body feels different. the insomnia, ringing in the ears, anxiety, floaters, memory problems, heart palpitations are all symptoms of ANXIETY so don't just blame them on Cipro and these symptoms are manageable and treatable. This condition really doesn't affect my life anymore since the change in attitude and acceptance that i can't change what has happened! People are happy blind and with cancer and with other crippling diseases so be glad it didn't kill you and move on with life...it's short so take advantage. it'll get better... it did for me and it can for you too! Faith helps but im not very religious so i made it without that. Also, i starting swimming which has been amazing! Start Swimming! Good luck Guys it'll get better and you can change the world if you overcome your hardships! FIGHT and it'll get better!

[bob]

Bayer recently admitted in an email to a floxed colleague of mine that the serious long term harm affected 1-10 in 10,000. If you take the upper figure it actually means 1 in 1000.
Every year 1 in 1000 get MS, so this makes the unbelievable statistic that Cipro gives the wider population a condition that is equally as adverse and damaging to health as MS and all from a prescription drug and in he same ratio. Bayer also went to mention that the prescribing Doctors know all about the long term side effects from this class of antibiotic. Well they do not and will not since the drug company manages to avoid printing the truth and sending out dear doctor letters.
I am sure if six pack joe was told that he could end up with a condition that mimics MS he would be enthralled to swap a sinus infection for a life as a cripple.
God help us all from this injustice

[YW]

My husband is a kidney recipient who took cipro for an upper respetory infection which 4 days later started with panic attacks, anxiety and parnoid. I did not link the effects to Cipro right away until I did some research someone else on effects of another antibiotic. Almost 5 months later and things have only gotten worse, his own nephrologist gave him the Cipro, he claims to have known no adverse reactions and gives it to all his renal patients. After going from one doctor to another, therapists, psycologists, I am at my ends wit. And KM posted on July 9, 2008, you are right! No one talks about the serious effects it has caused to younger people and horrible effects it takes on families. My husband does have a transplant and should of never taken this medication, he can't work effectively and is out on disability for a couple of weeks, I don't know if one doctor covers the other or if I am starting to loose it with my desperation, but I wish someone would listen.

[Pat Kamuda]

I I was prescribed Cipro for a bladder infection. 6 pill, 2 per day. After the last day, about 5 hours later I awoke with severe pain on my left side, similar to a gall bladder attack that lasted about 5 hours. When I questioned the pharmacist about it, he said if i was to have a problem with it, it would have shown up immediatly.

[Clayton Thomas]

It has been one year since i had my severe reaction to cipro. After taking the drug i had pretty severe anxiety,pain and inflexibility. I had a lot of muscle spasms and joint popping as well. I am very happy to report that today about a year later i rarely notice any of the symptoms or experience them at all. The worst part was the anxiety of "when will my tendon rupture?" "should i get out of bed right now with the pain?" I found that as stress was increased pain and anxiety increased. I have had a couple "bad days" but they are far and few between and my tendons are the least of my worries. I am mindful of what i do and don't do things that would irritate tendonitis. Swimming has been great for me and when i was in pain i would just relax and read to get my mind of it. Attitude is everything and IT DOES GET BETTER~! STOP READING ONLINE ARTICLES AFTER YOUR INITIAL RESEARCH! Do what you can to research and report your symptoms to the FDA. After that get on with your life! If you are still having pain you should learn to accept it and think of those who have it far worse and do amazing things with their lives! Grow from this experience and keep your head up. It got a lot better for me. I'm taking 7 classes in college, doing volunteer work and have a puppy which has made me much happier and when the pain was bad i would get people to help me when i could. Wish you all the best and if dwelling is your life you have got to stop reading about this reaction and move on. You can't take away the past so keep going.

-Clayton

[T Liepold]

I was on Cipro for 10 days to fight an UTI and bronchial pnuemonia. after 5 days I started to have joint pain in my hands and legs. I continued taking the medicine to get rid of the infection. It has now been 4 months and the joint pain is still there and is at times crippling. While on occasion I have pain in my right hand and lower back the left side of my body(shoulder,wrist,finger joints, knee and foot) is always in pain.

[Cipro]

I have taken Cipro and experienced hip pain in my right hip. After my physical my doctor told me i had tendinitis. I never would have connected the two, I thought I was doing too much yoga. What I haven't heard is, is this condition reversable?

[Ed]

These drugs should be taken off the market and reserved for very serious infections. I am pretty sure many Americans are ill from them, and many don't realize where all their pain is came from.