FDA requests black box warning on Cipro & Levaquin

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   Posted 7/8/2008 7:49 PM (GMT -6)   
As some of you might recall, I suffered serious and permanent damage to my hamstring tendons from taking Levaquin. The problem with the fluoroquinolone class of drugs causing tendonopathy and tendon rupture has been known for some time. Finally the FDA is requesting the manufacturers' black box a warning about the problem. This warning is very important so that people taking this med know that the minute they feel a twinge in a tendon, the must get it checked out. These meds are important antibiotics for those of us with IBD. But we do need to know what to lookout for too.

Moderator Crohn's Disease Forum
CD, Ankylosing Spondylitis, lupus, small fiber peripheral neuropathy, avascular necrosis, peripheral artery disease, degenerative disc disease, and a host of other medical problems.

Post Edited (Ides) : 8/13/2008 11:53:49 AM (GMT-6)

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   Posted 7/8/2008 8:07 PM (GMT -6)   
Thanks Ides hope you are feeling better lately. I did notice there were a few taking those meds. lol gail

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   Posted 7/8/2008 8:43 PM (GMT -6)   
Thanks for posting this Ides. How long were you on Levaquin?

I've only been on it shortterm after hospitalizations, but am glad to have this information for the next time.

-- I just noticed that the risk is higher for those on corticosteroids. Of course, I am always on those when I am on this drug.
Currently in remission!

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Date Joined May 2007
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   Posted 7/8/2008 8:59 PM (GMT -6)   
Thanks Ides- Only had to take the Levaquin once prior to my resect due to urinary tract problem. It may very well be a higher risk drug for me and the Fibro dx.
Dx'd Jan'06, 1st Resection 7/06, Humira, Imuran, B12 injections, Nexium, Lexapro, Glucosamine, Multi-Vitamin, Ultracet Secondary conditions: Psorasis, Osteoarthritis, Fibromyalgia, Lactose Intolerant, gallstones, peri-menopausal.

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Date Joined May 2005
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   Posted 7/8/2008 9:02 PM (GMT -6)   
I'm sure MamaDove will be thrilled as well.
26 Year old married female law student (last year!!). Diagnosed w/ CD 4 years ago, IBS for over 10 years before that, which was probably the CD. I am sort of lactose intollerant too but can handle anything cultured and do well w/ lactose pills and lactaid. For crohns I am currently on Pentasa 4 pills/4x day and hysociamine prn. I also have bad acid reflux and have been on PPI's since age 13. I have been through prilosec, prevacid, and nexium. Currently I am on Protonix in the morning and Zantac at night. I also take a birth control pill to allow some fun in my life.

Regular Member

Date Joined Feb 2008
Total Posts : 91
   Posted 7/8/2008 11:32 PM (GMT -6)   
I am sorry that you ended up with the contraindication of the drug Levequin. I am not sure if in the US you get a print out of all the information required for the patient with your medicaitons. I know that you do in Canada. These contraindacations have been there for years. Though the chances can be minimal the need to be there. It is like the ones with the medication of Remicade...I am one that ended up with a cranial bleed and lymphoplasmacytic infultrates due to it. This is reason that Canada no longer will allow Remicade to be used for children or young teens.

The worst of this is that you have to be careful for drugs that are in the same family as Levequin. I wish you the very best and hope that you don't have to suffer daily with it.

CD diagnosed 34 years ago
Stem Cell Transplant may be back on
Lap-assisted Ileocolic Resection- February 2008
Ankylosing Spondylitis
Back on Prednisone - I hate it
Ranitidine HCL 
Prednisone 1% (eye drops)
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B12, Folic Acid, Vitaman D, Calcium

Regular Member

Date Joined Dec 2006
Total Posts : 181
   Posted 7/9/2008 8:12 AM (GMT -6)   
Hi everyone,
This is a step in the right direction, however, your doctor must be able to read the black box warning and relay it to their patients...In my case, my doctors and nurses IGNORED the severe reaction and for months did everything they could do deter me from 'believing' it was from the Levaquin, even laughing at me at times and calling me a 'conspiracy theorist' and reiterating that they use these drugs all day and never have a problem...
My doctors and the staff at the local hospital as well as the Licensing Board and the State of Maine have done their very best to prevent me from blaming my badly damaged body and brain on Levaquin...
Also, my SEVERE reaction came as a result of mixing Levaquin with Solumedrol...A big NO-NO as far as the manufacturer states in the insert...And we all know the doctor never reads the insert! My husband found it online and brought it in to the hospital to show him as my body swelled and burned and he still wouldn't admit it...
Levaquin has caused me permanent damage and the list of problems is much too long to write at this time...I wrote to MedWatch, sent them my story (25 pages) in March and received a form letter saying that if they needed me further, they would contact me...People have been begging the FDA to put this warning on these drugs for years, had they done that before 2006, would I have been spared??? I am not so sure...
I do not trust doctors, nurses, hospital administrators and I esp. don't trust the FDA, their record speaks for itself...
So now when a doc prescribes Levaquin, Cipro and the other poisons, will they use their usual speech of how it was approved by the FDA AND they added a black box warning? I wonder if their are any consequences for them NOT INFORMING a patient of the potential risk...Of all the damage I have suffered, no attorney will touch it, yet it is more than likely now that thousands have suffered some form of damage from these drugs for the FDA to move their butts...
My husband seems to think that my letter in particualr, got the attention of someone due to the details and PROOF I sent along with it...It took me an entire week to put it together tongue I explained it would have taken me far less had I not been poisoned by Levaquin...That may have done it, huh?
BTW, I am starting to believe the LINK for these drugs and the damage is from the fluoride...Funny that someone in my local paper wrote a letter to the editor TODAY about how she had to do a report on the problems with fluoride over 40 years ago...She explains how she searched everywhere and could not come up with any 'cons'...Her partner in the debate called her one day and said she had discovered what they would use to debate the fluoride issue...Webster's dictionary definition of fluoride...POISON!
This life is becoming quite scary...Some experts believe that illnesses like fibromyalgia (of which I also have) and UC are actually fluoride toxicities...
Thank God some of us had the strength to beat back this evil thing and live to tell our story...
I am still suffering but I am happy to be here no matter how diminished my capacity is thanks to Levaquin...Now to help others avoid the same fate by getting the word out, without putting myself on the 'hit list'...And yes, I have been threatened by the powers that be, but that's another story...
Thanks for posting this, others need to see this...
Peaceful days ahead~MamaDove

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Date Joined May 2003
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   Posted 7/9/2008 9:04 AM (GMT -6)   
Just shows to go you that WE NEED to check the drug inserts ourselves whenever scripted a new medication and decide for ourselves if the need outweighs the risks and to be aware of possible side effects so we know when or when not to continue taking it.

The part of the insert that is ALWAYS of most interest to me is the little charts showing what percentage of how many people taking the drug suffered the listed side effect.
Some people are like Slinkies... Not really good for anything, but they still bring a smile to your face when you push them down a flight of stairs.

Texan with Crohn's
Regular Member

Date Joined Dec 2007
Total Posts : 362
   Posted 7/9/2008 10:56 AM (GMT -6)   
Wow - I had no idea. I am prescribed this often. Levaquin is the only antibiotic that my PCP and GI doctors prescribe for diverticulitis and any time my white blood cell count is up.

Thank you for the info.

Regular Member

Date Joined Jul 2004
Total Posts : 422
   Posted 7/9/2008 3:05 PM (GMT -6)   
I've been prescribed Levaquin for years each time I've had a UTI. Probably taken it at least 8 times...and I've had problems with swelling feet and pain in the back of my ankles. Think the next time I get a UTI I'll go back to the much older drug KEFLEX.
Diagnosed in October, 2004 at age 33.
Current Rx's: Colazal (generic), Nexium (generic), Ferrous Sulfate, One-A-Day multivitamin, Culturelle Probiotic, Omega-3 Fish Oil, Vitamin D, Vitamin A, Calcium-Magnesium-Zinc, Cranberry pills
Secondary conditions: mouth ulcers, joint pain, swelling ankles, extreme fatigue
Previous/occasional Rx's: 20mg Prednisone taper, Flagyl, Levaquin
No surgeries to date

Regular Member

Date Joined Oct 2006
Total Posts : 46
   Posted 7/9/2008 5:46 PM (GMT -6)   
Ok, Thanks for the warning on this.
I was just started a prescription of Ciprofloxacin (500MG Tabs, at 2 tabs Daily) along with everyones FAV. Perdnisone (40 MG daily for one week, with no tappering, and that worries me)
I'm going to be watching for side affects!!!

Regular Member

Date Joined Dec 2006
Total Posts : 151
   Posted 7/10/2008 6:49 AM (GMT -6)   
Although this is worrying news, people need to remember that black box label is simply like putting a big exclamation mark on the box, it's not the same as pulling the drug off the market. The fact is, this side effect is well documented, and has been well studied in the past. Cipro has been on the market for over 20 years and all of its potential side effects are well known. It seems that the latest studies showed this particular side effect is not recognized early enough and leads to many more patients suffering needlessly when it can and should be prevented. Putting a black box label on it means that manufacturers and physicians will be forced to explain the risk (and signs pointing to trouble) to their customers/patients much more clearly, and also, force the physicians to be much more careful about prescribing the drug, using it only when it's clearly indicated, and not as a low risk broad spectrum antibiotic, when others can be used. That said, tendon rupture is still quite rare, and it doesn't happen over night, there are very clear signs that precede it, so patients need to be made more aware and instructed how to react if they notice the warning signs. Let's not create a panic here, please.

Regular Member

Date Joined Dec 2006
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   Posted 7/10/2008 7:14 AM (GMT -6)   


Be extra vigilant when using quinolones and corticosteroids...It is said that is when the worst reactions occur...

I was IV Solumedrol when they added the Levaquin and that was it for me...The manufacturer said that major issues will occur in those over a certain age (60's)...I was 39, what's up with that?

I truly don't think they tell us everything, even on the inserts...

It really is a toss of the dice when you take a pharmaceutical drug...

If you happen to get any symtpoms and your doctor tells you 'it is not the medication' or 'it's an exaserbation of your disease'...think about this...this is what many of us have been told to convince us to continue the meds...After all, our doctors are the experts and wouldn't do us any harm... nono

Good Luck Dear...Keep us posted if you'd like~MamaDove

PS. DocGonzo...I beg to differ...Have you had a severe adverse reaction to these drugs? If not, please refrain from comments such as "let's not create a panic here".You are assuming that the manfacturer and the doctor now MUST educate patients or make sure they know what bacteria they are dealing with prior to administration...It says it in the insert!!! But they never tested me nor did they know the initial reaction and how to prevent further damage...THIS IS THE PROBLEM! I know there are issues and concerns with every drug but even after being so called 'educated', I was told that all of my new symptoms were coming from my severe disease...NOT! They also hid the fact that the reaction occured and did all they could to get rid of me after it happen but not before sending me to grueling rehab where they knew nothing of how to deal with a quinolone poisoning and only made me worse by demanding I walk more and more...I was actually doing more damage...These doctors know nothing and the manufacturer knows one thing~how to make money...This is not a cause for panic but an alert to be your own advocate...Educate yourself and know what is going into your body and what effects this may have on your well-being...As a survivor and a current sufferer still, I feel compelled to alert everyone who has a pulse...Don't be a victim in this...The reason the FDA finally moved their A** on this is that they received thousands of letters and emails regarding these reactions...The risk is not small, that's what they tell us...I have proof of otherwise...Believe me and take notes as I did and contact your physician (for what's that worth) and then choose to continue or discontinue...It's your life! Had I known that this drug could have done this to me, do you think I would have risked taking it esp. when the infection did not warrant it? I am not an idiot! But due to them I am now someone who has been poisoned by a quinolone and as some of us know, we wouldn't wish this on anyone, even our worst enemy...I would like my ex GI and nurse to experience it for 5 minutes tho, I would like to laugh at them like they did me...Take this very seriously...Thank you DocGonzo for your input, it allowed me to explain my position further.Also, we are not just talking tendon rupture here although that is the only thing they put forth in the warning...How about skin burning, bone breaking pain, brain frying (worst of all) and all the others..and the rupture of the tendon would have been a welcome thing for me, no it continued to swell and I couldn't step on it, bend my leg, walk, sit, etc. everything you normally do with a leg...and the pain was unbearable you wished for death...I know what PANIC feels like! Thanks for reading, just trying to make others aware that this is real, it's happening everyday and it needs to stop!

Regular Member

Date Joined Dec 2006
Total Posts : 151
   Posted 7/10/2008 11:36 AM (GMT -6)   

I'm very sorry to hear about your ordeal, but please remember that your case is probably the worst case scenario. If what you say is true, about the reaction of your doctors and nurses, I'm shocked and appalled and think you should sue their arrogant asses for everything they're worth. You're right, patients should be informed, and that's why this "black box label" exists, it's intended to bring "extra special" attention to a particular side effect of a drug, which is good, but also, it shouldn't create panic because, despite the negative side effect, this drug has a huge therapeutic value, and although sometimes severe these side effects ARE preventable. I just wish somebody was there for you when you needed that prevention, but that's exactly the point, isn't it - black box label ensures that extra attention that's obviously needed, and it ensures this drug won't be prescribed for benign conditions anymore.

Also, consider this - corticosteroids are virtually guaranteed to cause very serious very debilitating side effects in almost 100% of patients if taken long term, and still we take them, in huge quantities, despite all this. Why? Because they work. Because at this moment there are very few alternatives. Because without them some of us wouldn't be here today. It's the nature of the beast, and that's exactly why patients with these kind of diseases NEED to be as informed as possible. If you feel your doctor is not hearing you, seek second, third, fourth opinion, it IS your life we're talking about. I think, if anything, this is the most valuable lesson to be learned from your and similar cases...

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   Posted 7/10/2008 11:52 AM (GMT -6)   
Last summer, while on Cipro/methylprednisolone, I woke to find my ankle so sore that I could not stand on it!  I was essentially on bedrest, so I know it was not an over-use injury.  I've taken Cipro since, but always watching very closely how my ankle feels.  I never saw the warning just found it after it happened. 
--40 year old female, dx as UC in '04 (1st symptoms in '03), switched to Crohn's in '05, 1 fistula, crohn's colitis, limited to large intestine
--rejected (reaction/didn't work): Asacol, AZA, 6-MP, MTX, Remicade, Humira, prednisone
--methylpred - finally off 6/15/08, tried Prochymal in Phase III study (can't wait til it's approved!)
--started Tysabri 3/21/08, started Xifanan 5/24/08 
--single mom to 10-yr-old girl

Regular Member

Date Joined Jul 2006
Total Posts : 330
   Posted 7/10/2008 6:11 PM (GMT -6)   
Makes me think twice about my upcoming remicade - I had a bad reaction in which my joints ached for a number of days afterward. My doctor wants me to try it again to see if the reaction occurs again. I've agreed so far, but could I be playing a form of Russian roulette? How do we know when adverse reactions are going to happen that permanently cause damage? So far almost every drug for crohn's that I've been prescribed has caused a reaction that required stopping the meds (some annoying like hives and swelling, some severe leading to hospitalization like medication induced hepatitis and immunosuppression). I also had a bleeding disorder that was potentially linked to Flagyl (it mysteriously started while taking flaygl and has just as mysteriously stopped) and hospitalized me.
I've had such good success with remicade that I hate to give it up, but from this thread it's made me think really hard...could the next joint aches be permanent? I also had some weird neurological symptoms a few infusions ago but thankfully they've never returned. I don't know what to do. I need strong meds like remicade to get by. I can't face the thought of going back to the way things were when my crohn's was out of control. But everything always reacts with me eventually.

Thanks folks,


New Member

Date Joined Jul 2008
Total Posts : 5
   Posted 7/28/2008 12:28 PM (GMT -6)   


     Tendon ruptures & tendinitis seem to be the only adverse reactions making the news lately. There are so many more than that. The warning on these medicines say that rare occurrence of tendinitis & tendon ruptures can occur while or "after" taking these medicines. I don't think very many people know how long "after" means. My husband took Cipro 500mg in 1998. Around 11 months "after" he had his first rupture in 1999 in his left calf. It tore completely loose from where it was attached at the bottom of his ankle leaving his calf looking deformed. That left him with not only pain but a limp also. It's still torn away. In 2000, the quadriceps ligament tore at his right knee. It was operated on. In 2001, a quadriceps muscle tore apart in the center of his right thigh. It's still torn. Notice the quadriceps in the warnings isn't mentioned as tendons affected in ruptures nor are muscles. These ruptures came with no warning that anything was wrong. Around a month after he took Cipro, he had started having terrible rheumatoid arthritis type pain all over his body. Some of the things that started happening to him after taking Cipro in 1998 are involuntary movement of his arms & legs especially while trying to rest, insomnia, vivid nightmares, rectal bleeding, severe depression, suicidal thoughts & acts, a rash that looked like ant bites around his ankles, horrible swelled bottom left corner of his lip that only lasted a few days & other things. All these became far worse after taking CiproXR 1,000 in 2004. This was the second time he had ever taken Cipro. Around 11 months "after" taking CiproXR, the ruptures began again in 2005. This time in both his arms. He had 3 ruptures in 2005. There were also severe back spasms, frequent headaches & migraines, a rash that appeared in patches on his body that had bigger sores with dark centers, more cases of tendonitis, numbness worse in his legs & now affecting his hands, needles & pins sensation with burning feeling in his arms, vertical ridges in all his fingernails, lip swelled again like before and all the other things. The only thing that appeared to have ceased or showed some improvement after taking Cipro in 1998 was the rupturing had stopped, the severe depression seemed a little better & the suicidal thoughts & acts stopped, but that all came back too after taking CiproXR in 2004. My husband took a loaded .38, put it in his mouth & pulled the trigger, tried to electrocute himself, tried to burn himself & others I don't want to mention. He should be dead but ONLY God's Grace spared him. He was a former Marine who kept himself in shape through the years. He was in his early 40's when he first took Cipro. He was so strong & such a hard working man before all this. He's disabled now. The doctors never knew what caused the ruptures. ALL the things he has been through are listed on the adverse reactions on these medicines. There are worse things than tendinitis & tendon ruptures "after" taking these medicines.

Regular Member

Date Joined Dec 2006
Total Posts : 181
   Posted 7/28/2008 4:42 PM (GMT -6)   


After some weeks of this great NEWS, I am sorry to have to report that just as I expected, not much has changed...

I just came from my PCP...He had a new patient who was complaining of being unable to walk...My doc said it was frightening to see him when he walked in...He gave his history and anything he had done differently lately...

He took FLOXIN for a allergy related sinus issue...

My doc must have been listening to me becuase he immediately went to the fqr site and determined he was 'floxed'...His allergy specialist said he couldn't help him with his leg issue, he would need a PCP...He questioned what he read online about Floxin and the legs being 'rubbery' (just like I described it) and his doc said 'It couldn't be the medication, continue it if you want sinus relief'...


BTW, the most severe events occur while on corticosteroids and a quinolone like I described before...It happened to me...The pharmacist in the hospital didn't catch it when he filled it for my IV...During the investigation (Licensing Board of Maine) he admitted to knowing of no reaction in my case and therefore he did not notify the FDA...WHY??? Neither he caught it when he allowed it to go through NOR did the nurse who viewed the reaction write it down or discuss it again...These people are horrendous and no black box warning will save any of us...

Our best defense is knowledge and not to just trust someone cause they graduated from a medical school...Only a few graduate in the top of their class...The others still get diplomas to hang on their wall...

It is scary to have this happened and I have yet to see the 'lesson' I was supposed to learn from having to go through this horror...I am forever damaged/changed and I blame everyone from the maker to the giver and everyone in between...

Had I not been near death I could have requested the insert...Again, gratitude to my hubby who knew not to trust these vicious people and he ran home to figure out what was wrong with me...They still denied it even with the proof in my husbands hands...They still laughed at us...Called us difficult...Glad my husband had some ba**s and demanded that beast of a nurse remove it...

Had any of them admitted they were wrong on the first infusion, I would have likely not have been so bad...

I say line them all up, including the drug reps and we can do with them what they have done to us...Works for me!!!

Be vigilant and be your own advocate...No relying on THEM, THEY truly don't care about US...


Still waiting for the commercials regarding the class action lawsuits...Call 1-800-FLOXED, everyone that suffered a reaction will get a percentage of the billions in profits THEY made...After they compile the FACTUAL list, each of us will get $1.98 for pain and suffering...

Peace out~MamaDove

'ciprovictimalso'~Much sympathy for your husband and you...I feel his pain...I could also add to that list too of the horrifying aftermath...My brain was also 'fried' and noone wishes to do anything about it...and to think how many of our troops were USED...Cipro is for Anthrax...YAY! Hope Johnson and McNeil are happy with themselves...

New Member

Date Joined Jul 2008
Total Posts : 5
   Posted 7/28/2008 5:55 PM (GMT -6)   
MamaDove, You mentioned "still waiting for the commercials". Last week I saw the same commercial play twice on TV. Here is the information I wrote down.  The name of the Law Firm on TV asking about people with Levaquin damages to contact them. (Reich & Binstock 1-800-217-9267) I hope this helps someone. I don't know if they are accepting information about Cipro injuries but they are on their web site. Thank you all for letting me post on this site.

New Member

Date Joined Jul 2008
Total Posts : 5
   Posted 7/29/2008 11:34 AM (GMT -6)   


     I was looking for newspapers & TV stations to post what happened to my husband after taking a quinolone (Cipro) a few days ago. Somehow I ran across this board & posted here. I didn't know it existed before. It makes me wonder how many other people out there have been injured also. That law firm I posted the number for also have a web site. They have a place on it to post what people have suffered after taking these medicines. It's located at:

http://houston.injuryboard.com/fda-and-prescription-drugs/severe-injuries-linked-to-levaquin.aspx?googleid=244660 .

If this didn't paste right, it's on houston.injuryboard.com & the place to post at is listed under "Severe Injuries Linked to Levaquin (includes Cipro & other quinolones)". I don't know anyone on this board. I can't warn people about these medicines alone. If anyone has been injured after taking a quinolone, would you please tell what happened to you there. I sure could use some help. If I have offended anyone on this site, please forgive me. Thank you


                                      Connie aka ciprovictimalso

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Date Joined Jan 2005
Total Posts : 24909
   Posted 7/30/2008 12:13 PM (GMT -6)   
I totaly agree we have to be vigilant ( sp) in our awareness of what the antibiotics and other meds can do
I was on Vancomycin IV for months at at time not knowing the warning was out there but not on insert
That hearing los or damage to nerves in ears was a high risk especially if used for too long a period

I have no hearing in left ear and right is going as well
I know that this is not the same drugs you's are talking about but I wanted to add that Vanco can do damage as well if used to long especaiily thru IV
Been on Levaquin a couple of times not for long but I so appreciate this info IDES and others

ALL great info IMHO thanks for posting it


  DX With Crohns,Pyoderma Gangrenosum,Anxiety/Panic,Fibro & Other DD
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New Member

Date Joined Jul 2008
Total Posts : 5
   Posted 7/30/2008 4:08 PM (GMT -6)   
     Thank you for your understanding & kindness. I'm sorry for your hearing loss. I'm afraid to take any kind of medicine now. Seems like they all can cause damages. I looked up the medicine (Vancomycin). Rather frightening stuff. Another medicine to definitely avoid. 
     Thank you again for allowing me to post here.


New Member

Date Joined May 2008
Total Posts : 2
   Posted 8/8/2008 2:09 AM (GMT -6)   
I can tel you that after I was released from the hospital for a flare and received Levaquin i was very wobbly and weak. I fell flat on my face after a minor trip. I thought I was still weak from the hospitalization. My joints did feel "loose". I know when I worked as a Peds RN we never gave Cipro ( same class of antibiotic) to kids because it interfered with the growth plate.

Regular Member

Date Joined Jul 2008
Total Posts : 440
   Posted 8/8/2008 8:24 AM (GMT -6)   
 So, I've been having alot of pain in my ankles mostly my right for about 6 months and it seems to be getting worse! Could this be due from taking Cipro? My ankles swell and feels like I can't bend it. I've been on Cipro everytime they think I have an infection for the past 3 years. Wow!
What's is going on! Any suggestions?
I have an appointment with my Gastro Dr. not until Sept. Is this something he's gonna help me with? Or do I need to see another specialist.  Is this a side effect?

Veteran Member

Date Joined May 2003
Total Posts : 9448
   Posted 8/8/2008 12:50 PM (GMT -6)   

There is a quinolone e-mail support group at: quinolones@yahoogroups.com

As I remember it, you can also take part online in a forum at yahoogroups.com

Some people are like Slinkies... Not really good for anything, but they still bring a smile to your face when you push them down a flight of stairs.

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