Cipro (Generic: Ciprofloxacin) is in a class of antibiotics called fluroquinolone, which have come under attack in recent months as being linked to serious adverse side effects. More specifically, Cipro has been linked to tendonitis, tendon damage and ruptures in the Achilles tendon, the rotator cuff (shoulder), the biceps, the hand, and the thumb.
Breaking News: On July 8, 2008, drug safety officials imposed the government’s most urgent safety warning on Cipro and similar antibiotics, citing evidence that they might lead to serious tendon ruptures that could 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 literature for patients emphasizing the risks.
What is the Problem?
Initial Attempt to Add Warning: In August 2006, Public Citizen & the Illinois Attorney General petitioned the U.S. Food and Drug Administration to add a “Black Box Warning” to Cipro’s packaging and require pharmacists to give patients FDA-approved medication guides that also carry the warning of tendon rupture associated with the drug.
In addition, a nonprofit group petitioned for the same warnings as far back as 1996, however as the FDA granted the petition, it ended up being buried in the list of possible adverse reactions and so thus far been inadequate.
FDA Adds Black Box Warning to Cipro: 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 literature for patients emphasizing the risks.
The Number of Antibiotic Induced Tendon Injures & Ruptures are Startling
Tendon ruptures associated with these drugs continue to occur at a disturbing rate but could be prevented if doctors and patients were more aware of the early warning signals, such as the onset of tendon pain, and switched to other antibiotics.
The FDA must act and require black box warnings and patient information guides – (Source: Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group)
Some researchers speculate that fluoroquinolones are toxic to tendon fibers and may decrease blood supply in tendons that already have a limited amount of blood supply.
Update: The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysis reconfirms that use of Cipro and ciprofloxacin is associated with an increased risk of tendon rupture. It also demonstrates that despite the current warning of tendon rupture in the labeling for Cipro and ciprofloxacin, large numbers of tendon-related adverse events continue to be reported.
Antibiotics Linked to Tendon Injuries
- Cipro (Ciprofloxacin)
- Cipro XR and Proquin XR (ciprofloxacin extended release)
- Factive (gemifloxacin)
- Penetrex (Enoxacin)
- Tequin (Gatifloxacin)
- Levaquin (Levofloxacin)
- Maxaquin (Lomefloxacin)
- Avelox (Moxifloxacin)
- Noroxin (Norfloxacin)
- Floxin (Ofloxacin)
Antibiotic Induced Tendon Injury Statistics
The FDA’s database shows 262 reported cases of tendon ruptures, 259 cases of tendonitis, and 274 cases of other tendon disorders. These numbers may be higher since the recent FDA announcement.
- 61% of the tendon ruptures reported to the FDA was caused by Levaquin.
- 23% of the tendon ruptures reported the FDA was caused by Cipro.
Signs & Symptoms of Tendon Rupture
The tendon most frequently associated to the Cipro induced ruptures is the Achilles tendon, however Cipro has also been linked to tendon ruptures in the rotator cuff (shoulder), the biceps, the hand, and the thumb. Below is a brief list of symptoms often associated with an Achilles tendon rupture:
- sudden and severe pain
- swelling and bruising
- difficulty walking
Signs & Symptoms of Tendonitis
Symptoms of tendonitis that are produced near a joint aggravated by movement include the following:
- Mild swelling, in some cases
Tendonitis in various locations in your body produces these specific types of pain:
- Tennis elbow. This type causes pain on the outer side of your forearm near your elbow when you rotate your forearm or grip an object. Golfer’s elbow causes pain on the inner part of your elbow.
- Achilles tendonitis. This form causes pain just above your heel.
- Adductor tendonitis. This type leads to pain in your groin.
- Patellar tendonitis. In this type, you experience pain just below your kneecap.
- Rotator cuff tendonitis. This tendinitis leads to shoulder pain.