Levaquin (levofloxacin) is a member of a class of drugs known as quinolones, which are prescribed to fight bacterial infections. Recently complaints by users have led the FDA to put a "black box" warning on the drug to increase awareness of its link to tendon ruptures and tendinitis.
In 2006, Public Citizen filed a petition with the FDA, requesting that stronger warnings be issued regarding Levaquin tendon rupture side effects. The consumer protection group then filed a federal lawsuit asking the court to require the FDA to act on their petition-- requesting that new warnings be added about side effects of antibiotics--in accordance with the Administrative Procedure Act.
The FDA warning states: "Ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin. Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. Levofloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been confidently excluded. Tendon rupture can occur during or after therapy with quinolones, including levofloxacin."
Signs & Symptoms of Tendon Rupture
The tendon most frequently associated to the Levaquin induced ruptures is the Achilles tendon, however Levaquin has also been linked to tendon ruptures in the rotator cuff (shoulder), the biceps, the hand, and the thumb. Symptoms often associated with an Achilles tendon rupture are:
- sudden and severe pain
- swelling and bruising
- difficulty walking
Signs & Symptoms of Tendinitis
Symptoms of tendinitis that are produced near a joint aggravated by movement include the following:
- Pain
- Tenderness
- Mild swelling, in some cases
Tendinitis in various locations in your body produces these specific types of pain:
- Tennis elbow 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 tendinitis causes pain just above your heel.
- Adductor tendinitis causes pain in your groin.
- Patellar tendinitis causes pain just below your kneecap.
- Rotator cuff tendinitis causes shoulder pain.
Washington, DC: The potential for adverse responses to Levaquin increases with the expiry of Johnson & Johnson's (J&J) patent for levofloxacin, as it paves the way for generic manufacturers to introduce new sources of Levaquin into the drug market. [ 
Lumberton, NC: Levaquin side effects can be debilitating. Any patient who has suffered tendon ruptures or tears knows how painful the conditions can be—and many say they had no idea that Levaquin put them at an increased risk for tendon issues. [ 
Newport, RI: Some patients who have taken Levaquin know how debilitating the side effects can be—the drug has been linked to an increased risk of tendon tears and tendon ruptures. Mark P. (real name withheld) says he suffered Levaquin side effects and still feels the associated pain. [ 
