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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 have been taking cipro and levaquin since i have been 12 years old so much that i
am furious my body has hurt for a few years i got tendinitis in my wrist and my shoulder feels horrible.
i want something done about this and for the others who suffer
thankyou
tasa

Yes, and the Cipro you were taking aided you in getting better during times in sickness. Pharmokenetics is ARTIFICIAL and is a constantly changing science. New treatments bring relief to many, and adverse effects to some, its statistics and sucks to be in the negative side of them. Though I'm not disinclined to feel sorry for your "suffering", its mindsets and commentaries bred from such articles that ruin the medical system incurring extraneous costs than can go towards IMPROVING research rather than padding lawyer pockets.

So I leave people with mindsets with yours, do yourself and remain silent to things you're ignorant on.

Perhaps you should question your doctor on the necessity of antibiotics for every fever, viral infection and/or pain.

I took a fluorquinolone product for 2 weeks in the early 1980s. Shortly afterword, playing volleyball, my achilles tendon ruptured. About 4 months later, there were many articles about this possible side effect and a discussion of possibly stopping their production. What happened? Did everyone simply forget? Does the FDA just not know what they are doing or are the payoffs just too good? Somebody is not telling the whole story here.

People have to stop thinking of medicine as the end-all... There are times when medicine just isn't necessary and yet we still take them. Some people even take an aspirin before they go to the bar, in the belief that it might help prevent a hangover. Here's a clue... Any medicine may, or may not have side effects for any given individual. If you don't need it, don't take it. If it causes the side effect, stop taking it, inform your doctor, and move on to something else. If you store it up and use for something that it wasn't intended for, you only have yourself to blame. Science and medicine are not the perfect things that some believe them to be. They still have many flaws and many unknowns. Use common sense and take care of yourself. Stop blaming others... And, next up on the soapbox is the person below...

I am a T-6 para who uses cipro occasionally. I have shoulder pain that I attributed to over use from transfers and pushing the wheelchair. I am curious if any others have noticed problems. I will agres that I love cipro when I have a uti.

People with CF are often prescribed Cipro.....but it would be honorable if the doctor's would share these side effects, and give patients the choice to have a different antibiotic.

I am so happy to hear this. Two years ago I was given Cipro in the Emergency room when the Dr's could not identify my illness (fever, chills, etc). The drug seemed to help those symptoms within 1-2 days. They only had me take it for five days, but by morning five I was in extreme pain all over. Day 6 it was to painful to walk. I ended up back into the emergency room and was followed by many specialists that ran thousands of dollars in tests to only tell me that they felt like the Cipro had damaged my tendons. I was told that some people get better within a few weeks, some 6 months to a year and some never do. I was devastated. I still have many problems with the pain but do believe that someday I will be better. I am glad that people will at least know of the side effect and have the opportunity to understand the drug.

In 1997 after a bone marrow transplant in Seattle I was receiving follow-up care at the City of Hope. I was prescribed Levaquin and within two days noticed I was limping on my left foot. How could an antibiotic be the cause? My trusty $6.95 Pill Book advised that achilles tendon ruptures were uncommon but could happen. I discontinued the medication. My doctor at CITY told me that it could not be the Levaquin. I brought in my book the next time and he said "You learn something every day." Which I thought was not true in his case.

Last year during a second stem cell transplant at City, while wearing an allergy band to Levaquin I was "forced" to take a 6-day Levaquin IV treatment, for a "possible" early stage pneumonia. I fought against it but, my doctor and a pharmacist insisted -- and although I asked why was I wearing the allergy band if it was not going to be honored, I was steamrolled into those 6 I V days of Levaquin. Very fortunately, no adverse effects. But also, I didn't have any pneumonia. Modern medicine ain't it great?

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?

I would suggest that Bryan educate him or herself before belittling others. The fluoroquinolones are a known toxic chemotherapeutic agents that have been crippling patiients for almost forty years now. The FDA has failed miserably in providing adequate warnings for this class. Tendon ruptures is the least of the patient's concerns. More than half of these drugs have been removed from clinical practice due to severe toxicity issues including fatalities. Irreversible peripheral neuropathy is yet another ignored side effect. Bryan should read the more than 4000 medical journal entries, case reports, newspaper articles, etc., to be found at www.fqresearch.org that clearly documents how dangerous these drugs are. This black box warning does little to nothing to bring to the patient's attention that they risk being crippled for life after using this class. Perhaps if he or she had suffered these effects themselves they would understand what a miserable life those who suffer these reactions are doomed to live. It has NOTHING to do with a 'mindset' and everything to do with physical trauma caused by these drugs.

i took cipro , at least 10 times, for a month at a time. it was prescribed for a prostate enlargement. i now have tremendous back and groin pain. it now makes sense why i have been suffering so much.

I agree wholehartedly with Mr. Fuller. After taking a weeks worth of Cipro after a routine procedure in 2006, I have developed a 'constellation' of permanent side effects, both physical and psychological, none of which have been treatable with any therapy or drug to date. Weakness in my muscles, tendonitis, slowly deteriorating bones, chronic fatigue and tinnitus are the least of my problems. After seeing dozens of doctors, they all haven't got a clue, or maintain that I am just non responsive to therapy. Yet, if people ever looked at the raw medline reports and other anecdotal evidence published, they would see that for some people, rarely as it may ocurr, that Cipro is far worse of a poison than the minor infection they had. I have been 'ill' with these side effects for over 2 years. Let the FDA or the makers of Cipro explain that.

My freshman year of college, I took cipro for an infection and tore both of my achilles tendons! When it happened, I was immediately taken off of the drug by my physician, but it still did a lot of damage. I was so thrilled to hear about the black box warning now!

I also took cipro for 10 days. After that, I had severe foot and leg pain and went to the Podiatrist. I also had severe shoulder and arm pain. I am still having pain in my leg and shoulder.

It blows my mind that most patients trust their health and lives to pharmaceutical medicine, when the safety and efficacy of alternative medicine has been proven by innumerable respected journals and researchers. Pharmaceutical medicine should be the LAST choice, after an extensive list including chiropractic, acupuncture, herbology, homeopathy and more. Experienced practitioners of any of these modalities can handle most illnesses and diseases, as well as cleaning up the mess described by those unfortunate enough to have entrusted their bodies to the dangers of pharmaceutical medicine. Modern medicine desperately needs to return to the ancient tradition of "First Do No Harm".

I had been on cipro 3 times in one year when both ACL's detached from the bone attachments from an unseemingly simple twist.

I also agree with Mr. Fuller. Medicines like Cipro and Levaquin shouldn't be prescribed except in life or death cases when everything else fails. I wonder why other adverse reactions weren't listed such as suicidal thoughts or acts, involuntary muscle movements, gastrointestinal bleeding, depression, headaches, migraines, insomnia, vivid nightmares, anxiety, panic attacks, back pain, joint stiffness, edema (horrible swelling)of face, neck or lips, peripheral neuropathy, rash that looks like ant bite sores around the ankles, rash that appears in patches over the body with bigger sores with a dark center, etc. I wonder why it appears that people 60 or over seem to be the most likely candidates for tendon ruptures? Every person I have communicated to who had ruptures after taking a quinolone were between the ages of 20's-50's. None of them mentioned having any type of transplant. Some of them did take corticosteroid drugs, some didn't. It doesn't do any good to stop taking the drug if you already took it and 11 months later your tendons start to rupture. How does stop taking it help then? The damage is already done.

I HAVE TAKEN CIPRO FOR BLADDER INFECTION FOR YEARS. IS'T IT AMAZING THAT SINCE IT IS NOW GENERIC THAT THEY WANT TO BLACKEN IT'S NAME. WATCH A NEW ANTIBODIC COME OUT TO REPLACE IT THAT COSTS 6 TIMES THE PRICE. !!!!!!!! I'VE HAD NO PROBLEMS JUST FEEL 100%BETTER.

I took only 3 doses of cipro and it caused bilateral achilles tendinitis and bilateral tendinitis in both of my wrists. This has taken so far 9 months to get better and still not completely healed... I was a very healthy athletic 23 year old and got injured by this drug. My doctor said I would heal in 3 weeks! but it never happened.

But that isn't to mention the other things it caused me like Peripheral neuroapthy, chronic insomnia, muscle pains, dryness everywhere, spider veins all over my body and so on. I had up to 50 symptoms but now am just left with about 3... In time the body can heal, but NEVER take these drugs if you really don't have to!

I think I might be lucky and carry on leading a normal life again soon. Many are not lucky but can never work or do any activities again since taking quinolones.

I took Cipro in the hospital ofr Pneumonia back in april of this year. A few days later i complained of numbness in my fingers. no one thought much of it. i finally went to an ortapedic dr. and he sent me for an emg. I was told it was ulnar nerve damage and needed an operation. i wrote to bayer the makers of Cipro and they got back to me right away. they told me i needed to let my Dr. know of the cipro and that i was on steroids. I don't know yet if it is connected to cipro but I wish i had more information before taking and the Dr. should know too before opting to give it.

The FDA warning is not only inadequate, but it is just plain wrong.

Quinolones such as Cipro do not inrease the risk of tendinitis and tendon rupture. These agents CAUSE these injuries directly by activating enzymes that destroy the connective tissue within tendons and ligaments throughout the body.

Anyone exercising truly informed consent would refuse these drugs except in absolute life or death situations where every other antibiotic had previously failed.

There are other side effects which should be mentioned such as neurological, vestibular dysfunction, potentially dangerous, sometimes fatal, arrhythmia, heart failure, neuropathic pains, myalgia, arthralgia, general weakness and more.

I would like to expand upon my previous comments and add that EVERYTHING that the other posters have stated to have suffered while taking these drugs are KNOWN, LISTED AND DOCUMENTED adverse reactions to this class. The FDA is once again attempting to mislead and confuse the treating phyisicians by adding these so called 'additional risk factors'. Such muscle, ligament and tendon damage has been reported since 1982. The FDA has waited twenty six years to 'circle' the warnings they first added back in 1996. Big frickin deal. It has been documented in the medical journals since 1982 that these drugs have a DIRECT toxic affect on the patients tendons, muscles and ligaments which is even more pronounced when the patient does not even have a bacterial infection to begin with (which most patients taking these drugs do not even have a bacterial infection to begin with). They also have this very same affect on the patients peripheral nerves as well. Both of which have the potential of crippling a patient for life.

I would beg someone to explain to me how this only supposedly happens in the elderly when two patients immedately come to mind, both pediatric patients whose bodies were ravaged by these drugs. One patient blew out the ligaments in both knees mandating numerous surgeries to repair and the prognosis is not favorable by any means. Another who has been crippled for almost a decade now who also was a pediatric patient who was given this drug for an ear ache. She has blown numerous tendons and is now confined to a wheelchair. Neither of these patients were anything but normal healthy individuals prior to taking these drugs. One was treated for a finger nail infection and the other for an earache. Both are now damaged for the rest of thier lives and face sixty to seventy years of utter misery before they die. In a meeting of the FDA advisory committee back in 1996 the chairman stated for the record:

"…There have been sequelae in three cases with knee effusions persisting one year later in one case with discomfort following 8 months later in the second case. The third case is articular. It is a 17-year-old patient who experienced arthropathy and the drug was not suspected and the treatment was continued two following months. It leads to destructive arthropathy of the knees and the hip and prothesis was performed three years later. He was treated for a cerebral abscess. The outcome was unknown in 18 cases. In 9 cases, there was no follow-up. In the 9 last cases, we had a follow-up three months later and patients were not -- were still with disabilities and after we have no evolution…." (sic)
"… It is my understanding that one of the children had a joint replacement, is that correct?"
" Pardon me?"
" One of the children with the complications had an artificial joint replacement?"
"Yes."
"…If an irreversible cartilaginous lesion can occur, it is very likely that is going to cause problems down the line and we can't even anticipate what they are like…" (sic)

So as you can see the FDA has once again put the profits of the drug
companies ahead of the safety of the patient. Twelve years ago they knew full well what these reactions would be and choose to do NOTHING other than approve new drugs in this class, new indications for those already in use, all of which were devoid of any meaningful warnings. Those of you who continue to live in misery can send a thank you note to the corrupted indviduals running the FDA. They new damn well the risk that they had put you to and quite frankly my dears they didn't give a damn. And they still don't.

I took Cipro when I was deathly sick in a South America, it was life of death. I didn't have a choice, high fevers of 107 and no one knew why. I got worse and worse. After many months hospitalized I went to walk and tore tendons
and connective tissue only to have to have five surgeries to fix such. Now 18 years later, losing everything I had to medical bills, becoming totally disabled, and no one truly understanding why, I think they did. I've been to the best hosptials in the World, all said my how you just tear with any little bit of over exercise like 30 minutes on the computer can tear my connective tendons in fingers. I have many that just not longer function. I now take other medications. I read everything, and weigh what and whether it is worth taking. One doctor gave me Baclofen for my muscles within five days it had burned my who digestive tract. I stopped them and called him saying I'm not waiting til I see you. The Nexium can cause hip pain and more muscle problems however at the time I had no choice. I took them for 18 months and soon as "I" felt I was ready said it's time to stop. In this day and age, we must take active rolls in our own health and care. I would be dead if I didn't, my allergic reactions go on and on, and still I find doctors writing me a prescription for one. It up to me to tell them I'm sorry you made a mistake. Some don't like it but if you read this article then you must see that "Bully Doctors" can be reported and hospitals that don't have such a program will not be accredited. It's up to us the patient, it's what I call Social Genocide, those who can and do will live those who can't and won't will die. It's life with the medical situation in the United States today, I was told that over 1,000 people die a day from not knowing what or how to get or understand their illness or treatment. Fifteen minute turnarounds just doesn't give doctors enough time. Come prepared with a list and be informed, it's your life, now that you know about Cipro and other medications it's up to you to take action if it has effected you, and not legal action that will only bring about higher medical costs to you and me. Take action to be more informed in the future and isn't it wonderful that were still here to talk about it. Live life and stay healthy.

 


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