Warning on Tendon Injuries with Fluoroquinolone Antibiotics

October 2008- FDA has asked that a boxed warning be added to the prescribing information for fluoroquinolone antibiotics. The warning will remind healthcare professionals that patients taking these drugs may experience an increased risk of tendinitis and tendon rupture. Fluoroquinolones include Cipro (ciprofloxacin), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), Floxin (ofloxacin) and Proquin (ciprofloxacin hydrochloride).

FDA is concerned that large numbers of tendon problems were continuing to be reported, despite a warning that already appears in the labeling for these drugs. The boxed warning is being added to draw the practitioner's attention to this information. This can also affect the benefit-risk decisions that are made when these drugs are prescribed.

Certain patients are at greater risk for these injuries, including those over 60, those taking corticosteroids, and patients who have had heart, lung or kidney transplants. Certain tendons are also more likely to be affected. The Achilles is the most commonly affected, but other tendons can also be involved, including those in the rotator cuff, the biceps, the hand and the thumb.

It is important to remember that the risk for injury is not necessarily gone when the drug is stopped. Cases have been reported in which tendon problems occurred up to several months after the drug was discontinued. Also, this increased risk of tendon problems applies only to patients who are getting fluoroquinolones systemically; patients taking eye drops or ear drops are not affected.

Fluoroquinolones may be associated with serious risks other than tendinitis and tendon rupture. These risks are rare but may include convulsions, hallucinations, depression, heart rhythm changes, and serious allergic reactions.

Since fluoroquinolones are vital drugs in treating certain bacterial infections, the practitioner may decide that the benefits of the drug outweigh the risk for a given patient. In these cases, the practitioner should caution patients to watch out for pain, swelling or inflammation in a tendon area, because that could signal tendinitis, and to know the signs and symptoms of a tendon rupture.

If patients experience any of these things, they should avoid using or exercising that area of the body, stop the drug, and see their doctor about the possibility of switching to another type of antibiotic. It is important that patients understand what to look for and what to do, so FDA has asked the manufacturers of fluoroquinolones to develop a Medication Guide containing this information, which will be given to the patient with each prescription.

Category:

Science & Technology

Tags:

• Tendon
• Injuries
• Fluoroquinolone
• Antibiotics
• FDA
• Patient
• Safety
• Cipro
• Factive
• Levaquin
• Avelox
• Noroxin
• Floxin
• Proquin

[econogate]

I can't believe they try to market something like this that could cause such an irreversible damage to the user. I am wondering how accurate the statistics are for the adverse reactions, especially since it can occur many months later.

[econogate]

I was prescribed this but have declined to take it, never heard of tendon rupturing or ligament damaging anti-biotics. I have some kind of bacterial infection, one doctor said I have polyp in my nose another said I had sinusitus, and another said I had the flu! It's like curly, moe and larry! I am trying flonase for the nose, but so far no improvement. The one anti-biotic I did take worked but the doc only gave me 10 days worth and by day 14 my nose filled up again.

[GBelair]

@GBelair so TENDON INJURY is a serious understatement. doing activity or not won't help the fact that for the rest of your days, you wont be able to live without generalised tendon pain and varying degrees of loss of mobility.

[GBelair]

tendon injury, tendonitis?!?!? Thats not the real story, it destroys all connective tissue's materials that provide elasticity, especially collagen. The tendons lose elasticity, shrink, harden and hurt daily forever after. Skin, also has connective tissue, it starts drooping and thining and at age 30 you end up looking like a Sharpy Dog... seriously.

[bishopdante]

look up nalixic acid, that's what this drug comes from!!

[XxGenocideJunkiexX]

Wow! thanks for posting this. I was given Cipro yesterday for a cat bite that got infected. Ive only taken 2 pills out of 10 but even after the first one I woke up with pretty severe pain in my left shoulder and now I have pain in my left knee. There is no way in hell im taking another pill of this shit, or any other fluoroquinolone.

[jquimby3]

Never, never, ever take this drug. I took 7 doses and had loss of appetite and sleep, achy muscles, swelling in the fingers and ankles, sore tendons, and a feeling of being agitated. This was originally sold as a chemo drug so you know it is powerful with dangerous side effects. Whoever heard of selling a drug that can cause you to rupture a tendon!! Shame on them.

[vampirehunter33]

I could always tolerate ciprofloxacin well never had any trouble. I could take it for a month in fact I once had to because of an infection.. unfortunately it did not kill infection so now Im on Levofloxacin . and I'm throwing the junk away. levaquin has brought me a whole host of illnesses . tons of joint pain , weak and shaky hands , and now hearing loss in my right ear. the symptoms stop close to the 24 hour mark . and start again an hour after each pill .

[skootize]

STAY OFF THIS DRUG I WAS ISSUED CIPROFLOXACIN COUPLE OF DAY AGO , NO PROBLEMS THE FIRST DAY SECOND DAY II STARTED DEVELOPING A SEVERE LEG CRAMP WHICH WAS WAKING ME UP IN THE EARLY HOURS OF THE MORNING BY DAY THREE EVERY TIME I TOOK THE DAM PILL THE LEG CRAMP STARTED WITH IN 30MINS OF TAKING ...LAST NIGHT I WAS IN SO MUCH PAIN I WAS CRYING OUT ..THE OUT OF HOURS DOCTOR TOLD ME TO CARRY ON TAKING IT BUT THERES NO CHANCE OF THAT PLEASE DONT TAKE THIS SLOW KILL PILL

[johnangelo75]

@papatoony LOL I feel your pain