FDA Requires Black Box Warning for Tendon Ruptures on Cipro, Levaquin and Several Other Antibiotics

The FDA has notified the makers of fluoroquinolone antimicrobial drugs, such as Cipro and Levaquin, that they must place a prominently displayed Boxed Warning on the label about an increased risk of tendonitis and tendon ruptures. The pharmaceutical companies are also being required to develop a Medication Guide, which would be given to patients who receive the antibiotics, explaining the possible tendon damage side effects.

The drugs already contained information in their prescribing information about the possible risk of tendon ruptures, but many users and doctors remain unaware of the risk. Despite the current warnings, the FDA has continued to receive a large number of adverse event reports involving tendonitis and tendon ruptures. Officials have determined that additional information and stronger warnings are necessary to protect consumers.

“The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products,” said Edward Cox, M.D., director or the Office of Antimicrobial Products at the Center for Drug Evaluation and Research.

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In addition to allowing potential users to make an informed decision about whether the risks outweigh the benefits, the warnings and Medication Guide will also help raise awareness that users should immediately contact their doctor if they experience tendon pain, swelling, inflammation. Stopping the drug at the first signs of tendon problems, avoiding the use of impacted areas and avoiding exercise cacn reduce the risk that the tendon actually ruptures.

The Black Box tendon rupture warning will be placed on Levaquin (levofloxacin), Cipro (ciprofloxacin), Cipro XR and Proquin XR (extended release ciprofloxacin), Factive (gemifloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin) and Floxin (ofloxacin). The generic versions of Cipro and Floxin will also carry the warning.

While the risk of tendon ruptures among users of Cipro, Levaquin and the other fluoroquinolone antibiotics could apply to any patients, the FDA did indicate that the risk is further increased among users over 60 years old, those taking corticosteroid drugs, and those who have received a kidney, heart or lung transplant.

15 Comments

  • DaveFebruary 20, 2014 at 9:13 pm

    I have never had ankle problems of any kind. Recently I was prescribed cipro 500mg twice daily for an intestinal bacteria. On the second day I noticed a new pain in my right ankle. I am 68 years old and was only going about my daily activities. I took the meds for a total of 5 days and stopped since my ankle started to swell. From the internet I found out cipro causes tendon problems. My ortho doc[Show More]I have never had ankle problems of any kind. Recently I was prescribed cipro 500mg twice daily for an intestinal bacteria. On the second day I noticed a new pain in my right ankle. I am 68 years old and was only going about my daily activities. I took the meds for a total of 5 days and stopped since my ankle started to swell. From the internet I found out cipro causes tendon problems. My ortho doc has me scheduled for an mri. I still am dealing with this for a month, icing, elevating, and limiting walking. I am sure it is from the cipro. I suggest asking your doc for a different antibiotic.

  • DaveFebruary 20, 2014 at 5:36 am

    I have never had ankle problems of any kind. Recently I was prescribed cipro 500mg twice daily for an intestinal bacteria. On the second day I noticed a new pain in my right ankle. I am 68 years old and was only going about my daily activities. I took the meds for a total of 5 days and stopped since my ankle started to swell. From the internet I found out cipro causes tendon problems. My ortho doc[Show More]I have never had ankle problems of any kind. Recently I was prescribed cipro 500mg twice daily for an intestinal bacteria. On the second day I noticed a new pain in my right ankle. I am 68 years old and was only going about my daily activities. I took the meds for a total of 5 days and stopped since my ankle started to swell. From the internet I found out cipro causes tendon problems. My ortho doc has me scheduled for an mri. I still am dealing with this for a month, icing, elevating, and limiting walking. I am sure it is from the cipro. I suggest asking your doc for a different antibiotic.

  • JoshyMay 19, 2011 at 3:13 pm

    I took Cipro in 2008 for 45 days in two different occasions for a UTI treatment. In between this two I had a tendon damage on my knee and the doctor didn't correlate it with the Cipro !. Later I took the same poison again without knowing the tendon damage was caused by it. Even after 3 years of completing the course all my joints are weak and I can't do regular exercises like running as my knees a[Show More]I took Cipro in 2008 for 45 days in two different occasions for a UTI treatment. In between this two I had a tendon damage on my knee and the doctor didn't correlate it with the Cipro !. Later I took the same poison again without knowing the tendon damage was caused by it. Even after 3 years of completing the course all my joints are weak and I can't do regular exercises like running as my knees are so weak. Until recently I didn't recognize this as a side effect of Cipro I took. Recently, I developed a fatty liver and my doctor couldn't correlate it to anything (I am healthy, 6' , 170 pounds). A search on Cipro side effects on liver revealed many others who developed a fatty liver after taking Cipro. Please don't take this drug unless it is absolutely necessary. I have no clue what can I do to reverse these side effects (tendon damage, weakness in joints and a fatty liver !)

  • VanessaApril 21, 2011 at 8:14 pm

    Over the past 3 or so years I have had fasciotomy on both feet and now peroneal tendon repair on the right. The tendons were torn so badly that the doctor said they looked like spaghetti and were about to rupture completely on their own. Thank God I already had the surgery scheduled before that could happen. I am still recovering and unable to drive to the local pharmacies to pull up records on[Show More]Over the past 3 or so years I have had fasciotomy on both feet and now peroneal tendon repair on the right. The tendons were torn so badly that the doctor said they looked like spaghetti and were about to rupture completely on their own. Thank God I already had the surgery scheduled before that could happen. I am still recovering and unable to drive to the local pharmacies to pull up records on Cipro and Levaquin prescriptions. I do know, however, that I had Cipro in February of this year and my surgery was in March. I have been in pretty much continuous pain for 3 years and it may all be due to these medications. I do plan to do a full investigation as I know I have received these meds over the years for various bronchitis and other (cold-like) illnesses over this period of time.

  • MarjorieApril 8, 2011 at 5:15 pm

    When I picked up my perscription for ciprofloxacin the pharmacist warned me that it may cause tendon "weakness". After taking the drug for 5 days I developed extreme pain in the tendon below my right ankle (Peroneal Tendonitis) just as a result of normal exercise - walking and yoga. There was no unusual stress on this tendon during this time. It was so bad I was limping and it took months to h[Show More]When I picked up my perscription for ciprofloxacin the pharmacist warned me that it may cause tendon "weakness". After taking the drug for 5 days I developed extreme pain in the tendon below my right ankle (Peroneal Tendonitis) just as a result of normal exercise - walking and yoga. There was no unusual stress on this tendon during this time. It was so bad I was limping and it took months to heal. I couldn't support any weight on the ball of my foot, which means walking up stairs was a real challenge. I'd think twice about ever taking this drug again!!

  • AmyApril 20, 2010 at 4:16 pm

    I have developed tendonitis in my left achilles tendon. This started in August of 2009, the same time I was given Cipro (250mg) per day for 2 months to fight recurrent UTI. I had no idea how I tore my tendon, but now I suspect that it was caused by the Cipro. I have already had a Topaz procedure done, and was told by my doctor yesterday that I will probably need a tendon graft done to rid mysel[Show More]I have developed tendonitis in my left achilles tendon. This started in August of 2009, the same time I was given Cipro (250mg) per day for 2 months to fight recurrent UTI. I had no idea how I tore my tendon, but now I suspect that it was caused by the Cipro. I have already had a Topaz procedure done, and was told by my doctor yesterday that I will probably need a tendon graft done to rid myself of the pain I am having. I had no idea Cipro could cause this problem. I would think that a boxed warning such as this would be made way more prominent than it is.

  • RodgerApril 5, 2010 at 5:13 pm

    1 400mg dose of Avelox – dropping arms collapsing = 911 to hospital – April 4 2008 to death in hospital on 7-29-08 Torn ligaments – many side effects In hospital – IV Avelox closed throat caused mucus plug – all leading to her death 4 hospital stays later - Avelox Moxifloxacin

  • SusanFebruary 18, 2010 at 3:41 am

    I took Cipro 3 weeks ago for a UTI. This past Monday night I had a spontaneous right bicep tendon tear. I also took Cipro for 10 days in September 09. Follow up with Orthopod and probable MRI to determine extent of tear. Had to have ultrasound to rule out DVT due to severe hematoma on right arm. Pain is extreme. I had no idea there was a problem with Cipro.

  • PeggyNovember 19, 2009 at 5:24 pm

    I had an outpatient uretreral stent proceedure done on October 1, 2009, at which time I was given an injection of Levofloxacin before I left the hospital, along with a prescription for Ciprofloxacin, with instructions to begin taking it the next day (Friday). By Friday evening (early Saturday), I was in such agony with my legs that my husband called 911 for an ambulance. I was taken back to N[Show More]I had an outpatient uretreral stent proceedure done on October 1, 2009, at which time I was given an injection of Levofloxacin before I left the hospital, along with a prescription for Ciprofloxacin, with instructions to begin taking it the next day (Friday). By Friday evening (early Saturday), I was in such agony with my legs that my husband called 911 for an ambulance. I was taken back to North Fulton Hospital, Alpharetta, Ga., where they didn't have a clue as to what was the matter (nor did I). My orthopedic doctor was contacted, who also didn't know what was happening. Unfortunately, I had had a cortisone injection in one knee the day before the proceedure, but nobody made the connection (I am 77 years old). I was given morphine and ketorolac injections and sent home on crutches absolutely out of my mind with pain with instructions to call his office for an appointment the next week. I have spent the last six weeks on a walker and/or cane. When I tried to discuss the possible tendon problems with my doctors (the orthopedic doctor and the urologist), they denied knowing anything about such problems. No MRIS or further testing were ever done. I am still in terrible pain, but nobody seems to care.

  • janetMay 28, 2009 at 1:30 pm

    don't use cipro. I had it prescribed and for a long time i had knee problems

  • W. MaynardMay 11, 2009 at 6:11 am

    I have had ruptured tendons in both elbows, 5cm tears in both shoulder RTR Cuffs, and now a torn tendon in my right foot....! All within the last 4 years! First stop tomorrow is to the Rx to have my records for the last 6 years printed out, as I have had numerous sinus infections, and have had many different anti-biotics prescribed. I don't know if I have had this class of anti-b before, but this [Show More]I have had ruptured tendons in both elbows, 5cm tears in both shoulder RTR Cuffs, and now a torn tendon in my right foot....! All within the last 4 years! First stop tomorrow is to the Rx to have my records for the last 6 years printed out, as I have had numerous sinus infections, and have had many different anti-biotics prescribed. I don't know if I have had this class of anti-b before, but this is now WAY TOO much of a coincidence

  • First Levaquin Tendon Tear Lawsuit Scheduled For Trial August 2010 : AboutLawsuits.comFebruary 23, 2009 at 4:37 pm

    [...] effects of Levaquin have been found to increase the risk of tendon damage. The FDA required that a “black box” warning be added to all of the antibiotics in this class in July 2008, warning users that they should [...]

  • CaroleJanuary 22, 2009 at 1:47 am

    I have been taking levaquin for a sinus infection. I developed shoulder and arm pain that has kept me from work the past 2 days. I stopped the medicine and am hoping the pain will subside. In searching levaquin online, I found that another medication, Tequin, may be in the same group of antibiotics. I had a bad reaction to that med a few years ago & have it listed as an "allergy" in my med[Show More]I have been taking levaquin for a sinus infection. I developed shoulder and arm pain that has kept me from work the past 2 days. I stopped the medicine and am hoping the pain will subside. In searching levaquin online, I found that another medication, Tequin, may be in the same group of antibiotics. I had a bad reaction to that med a few years ago & have it listed as an "allergy" in my medical record. Are they the same drug group & should I have been prescribed levaquin if I cannot tolerate Tequin? I can't understand how this could have happened?!

  • BrianJanuary 20, 2009 at 1:55 am

    I took cipro back in july of 08 for a bladder infection, I spent 2 months barely walking, I didn't know what was causing the pain in my tendons, heals and toes, my mornings are a nightmare, it takes me a good hour to get to the point were I can even walk, I seem fine while I work and walk after I get going in the morning, however if I stop moving for around 20 min. my nightmare starts all over, I [Show More]I took cipro back in july of 08 for a bladder infection, I spent 2 months barely walking, I didn't know what was causing the pain in my tendons, heals and toes, my mornings are a nightmare, it takes me a good hour to get to the point were I can even walk, I seem fine while I work and walk after I get going in the morning, however if I stop moving for around 20 min. my nightmare starts all over, I went to a foot doctor, he told me I have bone spurs in my heals I just laughed this isn't bone spurs I have had bone spurs, its like stepping on a tac that not what this is, I think this is going to be a life long problem, I don't think there is anything anyone can do about it.

  • GilbertOctober 10, 2008 at 12:12 am

    I was just prescribed Cipro by my doctor. At the time I didn't remember the wwarning against it until I got home. I then called the pharmacist and asked him about it. He told me that he didn't know anything about a black box warning. Evidently my physician either did not know about it either or ignored it. This is a short term treatment for a local infection and I plan to take it. But I wonde[Show More]I was just prescribed Cipro by my doctor. At the time I didn't remember the wwarning against it until I got home. I then called the pharmacist and asked him about it. He told me that he didn't know anything about a black box warning. Evidently my physician either did not know about it either or ignored it. This is a short term treatment for a local infection and I plan to take it. But I wonder about the value of FDA warnings when they don't reach the pharmacists and are therefore not implemented.

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