Health risk warning for Cipro

[~*~Christine~*~]

U.S. issues warning about Cipro-type antibiotics

Updated Tue. Jul. 8 2008 6:42 PM ET

The Associated Press

WASHINGTON -- Drug safety officials Tuesday imposed the government's most urgent safety warning on Cipro and similar antibiotics, citing evidence that they may lead to tendon ruptures, a serious injury that can leave patients incapacitated and needing extensive surgery.

The Food and Drug Administration ordered makers of fluoroquinolone drugs -- a potent class of antibacterials -- to add a prominent "black box'' warning to their products and develop new literature for patients emphasizing the risks.

Tendon ruptures are normally thought of as sports injuries, generally occurring among men in their mid-30s. The link to treatment with the antibiotics is highly unusual, and scientists still don't fully understand why it happens. However, FDA officials stressed that many of the serious injuries appear to be preventable if patients stop taking the drug at the first sign of pain or swelling in a tendon, call their doctor, and switch to another antibiotic.

The two leading drugs covered by the warning are Cipro, made by Bayer, and Levaquin, which is made by Ortho-McNeil. Cipro became a household name during the anthrax attacks of 2001. It is effective against that deadly bacteria, and is among the drugs stockpiled by the government in case of a bio-terror attack. In everyday medicine, Cipro is often used to treat urinary tract infections. Levaquin is generally used to treat respiratory infections. The FDA warnings do not apply to fluoroquinolone drops used to treat eye infections.

The FDA's action came after the consumer group Public Citizen petitioned -- and later sued -- the agency for such warnings. Regulators took too long to act, complained Sidney Wolfe, head of the consumer group's health section. Many injuries "would have been prevented if patients and doctors had known a pain in the tendon is an early sign that leads to rupture,'' Wolfe said. Public Citizen's original petition was filed nearly two years ago.

FDA officials pointed out that prescribing literature for the drug class already carried clear warnings of the risk of tendon rupture. They said the agency acted to emphasize the warnings because continued reports of injuries indicated that the message may not have gotten through to doctors and patients.

"The continued reports demonstrate additional steps are warranted to better manage the risk of tendon rupture,'' said Renata Albrecht, director of an FDA office that focuses on unusual microbes.

FDA officials said they had received several hundred reports of tendon ruptures, but would not cite a specific number. Wolfe, of Public Citizen, said the number was 407 at the end of 2007, with another 341 reports of tendinitis. He continued to criticize the agency, saying it should also require drug makers to send individual letters to doctors about the risks. FDA officials said manufacturers could choose to send such letters on their own.

Tendons are cords of tissue that join muscles and bones, and are essential in movement. The most common kind of rupture reported to the FDA involved the Achilles tendon in the heel, but some also involved the rotator cuff in the shoulder, and tendons in the hands, biceps, and even the thumb.

Some of the ruptures reported to the FDA occurred without warning -- the patient felt a snap or pop soon after starting treatment. That suggests fluoroquinolone antibiotics may be toxic to some people, the FDA said.

But typically, patients felt some kind of pain or inflammation for a week or two before they suffered a tendon rupture. That suggests that many of the most serious problems can be avoided if patients stop the drug, officials said.

The FDA's analysis found that patients with the highest risk of problems include people over 60, those with kidney, heart and lung transplants, and those also taking steroids.

Manufacturers called the tendon ruptures a rare side effect. They said are complying with the FDA order and remain confident that the drugs' benefits outweigh their risks.

http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20080708/us_cipro_080708/20080708?hub=Health

[BrittanysDance]

and they knew this 2 years ago :cussing: and are just now letting the cat out of the bag? Disgusting...

THIS is part of the problem with big companies now a days....its all about the $$ and forget about the people it affects until AFTERWARDS.

Utterly disgusting...yet it happens every day.

[ICNDonna]

Thanks for sharing.

Donna

[SharonA]

I heard about this on the news last night, but missed most of the details. Thank you for posting the information.

[crkshnks79]

Thats scary ! My primary always gives me cipro and levaquin for everything !!! Thanks for posting this !!

[vm]

FDA officials pointed out that prescribing literature for the drug class already carried clear warnings of the risk of tendon rupture. They said the agency acted to emphasize the warnings because continued reports of injuries indicated that the message may not have gotten through to doctors and patients.

I do remember reading about this risk in my antibiotic literature in the past. I'm glad they'll be making it a more prominent warning now.

[jen74]

I had severe pain in my left arm after taking cipro back in December when I had a UTI. The pharmacist said it can cause spontaneous tendon ruptures in some people. What is scary is when I told my urogyne this, he said he never heard of cipro having this kind of side effect. My bacteria are now resistant to cipro, so I guess it does not matter in my case.
Jen

[hollipop]

Wow....I've had all types of tendon and synovial joint inflammation....could be related, although I can't say that I would ever regret taking the antibiotics in the past. I was on Cipro for a month once, and many short-lived times, but like jen74, I am now resistent to it anyway, so I guess I don't have to worry now. I take MSM daily for my inflammation now, and all of it went away.

[icnmgrjill]

More info... for those who are interested!

To report any unexpected adverse or serious events associated with the use of fluoroquinolone antimicrobials, please contact the FDA MedWatch program and complete a form on line at http://www.fda.gov/medwatch/report/hcp.htm or report by fax to 1-800-FDA-0178, by mail using the postage-paid address form provided on line, or by telephone to 1-800-FDA-1088.

FDA is notifying the makers of fluoroquinolone antimicrobial drugs of the need to add a Boxed Warning to the prescribing information about the increased risk of tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients.* Fluoroquinolone antimicrobial drugs are used to treat various bacterial infections. Marketed fluoroquinolone antimicrobial drugs include ciprofloxacin (marketed as Cipro and generic ciprofloxacin), ciprofloxacin extended release (Cipro XR and Proquin XR), gemifloxacin (marketed as Factive), levofloxacin (marketed as Levaquin), moxifloxacin (marketed as Avelox), norfloxacin (marketed as Noroxin), and ofloxacin (marketed as Floxin and generic ofloxacin).

The information regarding warnings for fluoroquinolones and adverse effects on tendons applies to fluoroquinolones for systemic use (e.g., tablets, capsules and injectable formulations); it does not apply to fluoroquinolones for ophthalmic or otic use (e.g., eye drops and ear drops).

Recommendations and Information for Healthcare Professionals to Consider Regarding Fluoroquinolones:

* Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, those on concomitant steroid therapy, as well as in kidney, heart, and lung transplant recipients. The fluoroquinolone should be discontinued if the patient experiences pain or inflammation in a tendon (symptoms that may precede rupture of the tendon), or tendon rupture. Advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their healthcare provider about changing to a non-fluoroquinolone antimicrobial drug.

* Healthcare professionals should consider the potential benefit and risks to each individual patient before prescribing a fluoroquinolone antimicrobial. While most patients prescribed fluoroquinolones tolerate these medicines, rarely patients develop serious adverse reactions which may include convulsions, hallucinations, depression, QTc prolongation and torsade de pointes, or Clostridium difficile associated diarrhea. Rarely, damage to the liver, kidneys or bone marrow, or alterations in glucose homeostasis may occur.

* Fluoroquinolones should only be used for the treatment or prevention of infections that are proven or strongly suspected to be caused by bacteria. Fluoroquinolones, like other antibacterial drugs, do not treat viral infections such as the common cold or influenza.

Information for Healthcare Professionals to Provide When Counseling Patients:

* Tendon rupture

o Pain, swelling, inflammation, and tears of tendons including the Achilles, shoulder, hand, or other tendons can happen in patients taking fluoroquinolone antibiotics. Tendons are the areas that connect your muscles to your joints. The Achilles tendon is at the back of the ankle. The chance of getting tendon problems is higher if you are:
+ over 60 years of age
+ taking steroids (corticosteroids)
+ a kidney, heart, or lung transplant recipient

o Other reasons for tendon ruptures include:
+ physical activity or exercise
+ kidney failure
+ tendon problems in the past, such as with rheumatoid arthritis

o Call your healthcare provider right away at the first signs or symptoms of pain, swelling or inflammation in a tendon area. These could be symptoms of tendinitis or tendon rupture. Stop taking your fluoroquinolone until a healthcare provider has determined that you do not have tendinitis or a tendon rupture. Signs or symptoms of tendon rupture include:
+ a snap or pop in a tendon area
+ bruising right after an injury in a tendon area
+ inability to move the affected area or bear weight

o At the first sign of pain, swelling, or inflammation in a tendon area, avoid exercise and use of the affected area.

o Talk to your healthcare provider about the risk of tendon rupture with continued use of a fluoroquinolone and whether you should be prescribed a different type of antibiotic to treat your infection.

* Tell your doctor about other medicines that you take and other medical conditions that you have. Some medicines may interact with a fluoroquinolone and cause serious side effects. Also, some medical conditions may make you more likely to have a serious side effect when you take a fluoroquinolone.

* Fluoroquinolones, like any drug, have possible side effects associated with their use. Rarely, some side effects may be serious or even fatal; however, most of the risks are mild. Some of the most serious side effects include seizures, hallucinations, depression, heart rhythm changes (QTc prolongation and torsade de points), and intestine infection with diarrhea. Rarely, damage to the liver, kidneys or bone marrow, and changes to blood sugar may occur.

* Fluoroquinolones are antimicrobials that are effective in treating infections caused by certain bacteria. They do not help to treat infections caused by viruses, such as a common cold or the flu.

Background Information

A warning about the increased risk of tendinitis and tendon rupture in patients taking fluoroquinolones was previously added to the prescribing information for fluoroquinolones. However, 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.

Tendinitis and tendon rupture most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, and the thumb have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is especially increased in patients over 60 years, in those concomitantly taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Tendon rupture can occur during or after completion of fluoroquinolone use; cases occurring up to several months after completion of therapy have been reported.

Tendon rupture is a serious adverse event that could potentially be prevented or reduced in frequency or severity by appropriate use of a fluoroquinolone, patient selection, and careful monitoring. Therefore, FDA is notifying the makers of the fluoroquinolones of the need to add a Boxed Warning to the prescribing information for fluoroquinolones to highlight and strengthen the existing warning about the increased risk of fluoroquinolone-associated tendinitis and tendon rupture. FDA is also notifying the makers of fluoroquinolones of the need to develop and distribute a Medication Guide to alert patients about these possible side effects.

*This notification was made under FDA’s new authority to require safety labeling changes and risk evaluation and mitigation strategies provided in Title IX of the FDA Amendments Act of 2007 (creating new sections 505(o)(4) and 505-1(a)(2) of the Federal Food, Drug, and Cosmetic Act).

[Miss.Anthropy]

I actually heard of this before after doing some research on Levaquin before taking it AND I asked my doctor about it. There are a lot of threads on different forums written by people who have experienced permanent tendon & joint damage from Cipro, Levaquin, etc. I was VERY scared to take the Levaquin, but my doctor reassured me that since I have taken Cipro before I probably wouldn't have any problems with it. Unfortunately, it is the antibiotic that they prescribe the most for my UTI's now. I haven't had any problems with it at all, but now that they're announcing this publicly I think I'll ask for a different type of antibiotic from now on.

[elitynski]

It's interesting that I was feeling some achilles tendon issues during my cipro treatment - and I'm wondering if this is what it was related to. I don't think I could take one more thing going wrong with my body at this point.

[jen74]

I know I have taken cipro quite a few times in the past for UTI's and did not have this issue at first either. But last time I used cipro which was in December of last year, I had severe charlie horse like pain in my left upper forearm. I talked to my pharmacist and they told me all flourinoquolones are linked to tendon ruptures/damage. I stopped the drug and it did take a few weeks for my arm to get back to feeling better. I believe that the more you take this type drug, the more chance you will get a reaction like this. Like I said, I had taken cipro at least 6 times in the last few years before I got this reaction.
Jen

[NikkiM]

Please be careful when taking any fluoroquinolones. Some doctors falsely believe that if you haev taken it in the past and not shown signs of an allergic reaction, then it is safe for you to take it! Not true! I took this drug several times before I was floxed and did not react until it was too late. Now I can't walk and I have nerve damage, AND it did not clear up my UTI issues. Also, another doctor told me that the more of this drug you have in your history, the more difficult it can be to recover. Just another warning. I would look into alternative medicine in the future. Something that does no harm!

[nanawaggs]

Hi, NikkiM ~ When you say you can't walk and have nerve damage, what exactly are your symptoms/where is your pain?

Thanks for the help.

[NikkiM]

Hi, NikkiM ~ When you say you can't walk and have nerve damage, what exactly are your symptoms/where is your pain?

Thanks for the help.

I have Cipro Toxicity or Fluoroquinolone Toxicity syndrome from taking Cipro. I can't walk because the Cipro was taken with ADVIL, an NSAID, which dilated my vascular system and caused the Cipro to enter my brain and central nervous system. I have peripheral nerve damage in all four limbs, and tendonopathy in 21 tendons, as well as a torn rotator cuff. These symptoms appeared after I discontinued the Cipro. For more details, you can see my blog here. (http://www.survivingcipro.com/http:/www.survivingcipro.com/uncategorized/117/about-us/my-cipro-story/)

My primary concern is that people think because a doctor casually prescribes something that it is safe, or that the FDA only approves safe drugs. Neither are true.

Blessings to you and on your recovery, Nikki

[some_guy]

NikkiM wow sorry to hear you had so much trouble with those type of antibiotics.

I took long course of levaquin and cipro in the beginning and was very worried about the tendon rupture thing at the time. I remember using extra care (not that it would have helped) hiking up some large hills that my dog and I were doing every morning.

I wish you the best and hope you get the best care to recover as much as possible.

[Julie B]

Sadly, this happened to my daughter. She has permanent tendinitis in her Achilles and has to wear a brace most nights on her ankle. She had a horrible kidney infection when she was in college, they loaded her up with floxin iv and sent her home on cipro for three weeks afterward. Honestly, she was in very very bad shape......I don't know what they could have done differently........they were nearly miraculous in beating back the infection, but there are risks with everything.............

One thing to keep in mind is to not do strenuous exercise when you are taking the stuff...............

[Mothergoose]

Sorry to read this happened to your daughter, but as you kinda said the Dr. did what they needed to do to knock out the infection.

An untreated infection in the kidney could cause worse problems for her.

So what do you do, and many people take it with no problems, it is one of those symptoms that may occur and of course do occur in a certian % of people, but I don't think in my expirence Dr. explain the risks to people enough, to let them make an educated decission.

I am truely sorry this has happened to your daughter. MG

[Julie B]

Mothergoose, it really is a catch 22, but a lot of medical treatments fall into that catagory. I suppose you could say that her Achilles issue is a reminder that she is alive when she could have died. I know my tummy was never the same again after three pregnancies and three C-sections, but I wouldn't give up my kids. :-)

The important thing is to know what the risks are....it sure would help if the doctors actually told people, or the pharmacists. Maybe we all have to read those inserts better they give us! :-)

[MidnightMoon]

Oh I feel so sorry for people who have been hurt from the drugs.

I started Norafloxacin which is a differnet name for a similar drug. has warnings about the tendons. I didnt take much notice of it.

I was only on the drug for a week and started a new job that used the computer instensivly. I got bad bad pains in my mouse arm, the doctor said tendonitis, and i had to quit the job (even though only been working at it for a few days) because pain was terrible and cant do other duties except use the computer non stop like I was doing.

I have had arms pains from over using computer before. So I guess its just the same thing but worse pain.

What concerned me though was 2 nights ago i started getting achilles tendon pain after a short walk and ive never gotten pain there before.

I stopped taking the drug after a week so i guess thats not long enough to do damage is it.
My husband wants me to keep taking it but i am worried its caused tendon problems already!
The doctor said no the arm tendonitis cant be from the drug because its too specific to computer use. However the achilles pain didnt start till i after I had walked home from the doctors the other night.
Last night it was sore as heck.

Im going to see a doctor on monday but i know they will tell me, its all in my head and the arm tendonitis is from the computer.

How long do you have to be on that drug before it causes tendon problems? A week is too short?

[wee wee warrior]

Unfortunately, a week is not too short of a time for cipro to damage your tendons. There are many studies regarding the damage it can do. I was on it for 11 days and developed bilateral achilles tendonitis, and literally had to crawl around my house for a week. It did finally resolve, only to flair again in February, on my left ankle. The main thing is to stay off of it -- truly don't use it. I do think cipro is a necessary evil, however there are other antibiotics and it should not be used as a first line treatment, as mine was. It is used to treat anthrax -- using it to treat UTI's without trying other, less dangerous antibiotics is irresponsible. My doctor who prescribed it for me actually ruptured her tendon and is no longer able to run (she was an avid runner). She admits that she was taking cipro when she stepped off of the curb and ruptured her tendon, so she knew it was from the drug.

Many, many people have been permanently disabled from it, and it took me 2 months to get over both of my bouts with tendonitis, but I DID get over them, with staying off the joint. Now when I exercise I am much more aware and when I feel that first twinge of pain with my Achilles, I stop and rest it.

I have to say my interstitial cystitis improved 100% on cipro (Why is that, does anybody know), but three days after I stopped it it was back.

[Mothergoose]

I have been cipro for the last 7 days. I think for the most part it doesn't work on me any more for UTI's as I have had to use it too many times, I have luckily never had any of theses sorts of problems with it.

Today is my first day off of it and I realize now just how crappy it was making me feel, i feel quite a bit better today, it may just be coincidence, but I think it is not taking the cipro.

MG

[MidnightMoon]

I am supposed to be on it for 3 months. My husband will hit the roof if I dont take it.
He doesnt beleive me when I say it might've caused my arm and heel pain.

my heel is OK now, my hand/arm is still bad.

I have no infection showing, but the specialist said sometimes a bug can get under the bladder lining and it won't show up on any tests for infection.

I have in the past had lots of infections and taken Erythromincin for the them as I am allergic to penecillin.

Most recently though, like the last 5 years, no infection has shown up when I go to the doctor with pain. I could swear I have an infection cause it hurts so much but Nope, nothing is there. That is why I went to specialist, who says I have painful bladder syndrome and that this norfloxacin drug will kill any bugs that could be under the bladder lining and not showing up on tests.

My husband will go bananas if I dont take this drug though, he is fed up with my bladder pain as I am.

I did not know a week is enough to cause damage. That is extremely worrying!
Are there any papers to read that say this? I need to show my doctor and husband.

[wee wee warrior]

Absolutely there are papers -- have your husband google "Cipro tendonitis" or "Levaquin tendonitis" (they are both fluoroquinolones). I didn't catch where you are from -- in the US Cipro is what they call a black box medication -- meaning there are pretty significant warnings on the information they give you that comes with your medication when it is filled. There is actually currently a class action lawsuit against the pharmaceutical company that makes Levaquin, regarding ruptured tendons. I'm all for trying whatever you can to make yourself feel better, but 3 months of cipro seems excessive to me. Worst case scenario you end up with a bladder that still hurts and permanently crippled. Not trying to scare you, but don't let anyone, even someone who loves you, try to tell you to ignore your body and what it is feeling. You know your own body best.

[loraleena]

I took Cipro for my last UTI in 2007 after macrobid didn't work. I took it for 3 days and started to hurt all over. I went online and saw the horror stories. I stopped it right away and the pain stopped. I will never touch it again. I have heard of people's tendons snapping after 1 or 2 days on it.

[marycat2007]

I was taking Cipro last week. Upon awakening each day, my Achilles tendon was really sore as if I had been hiking on rough terrain the day before. Also my ankles kept cracking last week. I've taken Cipro on 10 or so occasions in the past 7 years and I've had horrible bursitis in my hip. Wonder if it's related to Cipro. IC is scary enough without these horrible newly founded side effects of meds. Thanks for the all the posts on this topic.

[Julie B]

Mary Cat, I am so sorry to hear you have the tendinitis. The other thing I just researched was some drug interactions for common IC medications. Cipro has a lot of drug interactions. It is important to research your meds with this crazy disease.

[blueberry72]

Wow, this is a bit of a downer. For me, Ciprofloxacin is the only antibiotic that works for UTIs. When doctors have prescribed me Trimethoprim in the past I always have had the symptoms again within days of being done with the course of pills.