FDA Requires Black Box Warning for Tendon Ruptures on Cipro, Levaquin and Several Other Antibiotics
Published: July 9th, 2008 • Comments: 8
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.
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.
Comment by Gilbert on 9 October 2008:
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.
Comment by Brian on 19 January 2009:
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.
Comment by Carole on 21 January 2009:
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?!
Pingback by First Levaquin Tendon Tear Lawsuit Scheduled For Trial August 2010 : AboutLawsuits.com on 23 February 2009:
[...] 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 [...]
Comment by W. Maynard on 11 May 2009:
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
Comment by janet on 28 May 2009:
don’t use cipro. I had it prescribed and for a long time i had knee problems
Comment by Peggy on 19 November 2009:
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.
Comment by Susan on 17 February 2010:
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.