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Levaquin® PDF Print E-mail

Produced by Ortho-McNeil-Janssen Pharmaceutical
Possibly linked to Tendonitis and Tendon Rupture

On July 8, 2008, the FDA requested that Ortho-McNeil-Janssen Pharmaceutical, the manufacturer of Levaquin®, place a "black box" warning on Levaquin® packaging. The warning will caution patients of the risk of tendonitis and tendon rupture associated with use of the medication.

About Levaquin®

Levaquin® (Levofloxacin) is a 3rd-generation fluoroquinolone antibiotic, most commonly prescribed to treat bacterial infections of the lungs, sinus, skin, or urinary tract. Levaquin® is most commonly prescribed to adults only, as problems with joints have been reported when it is administered to children.

The Side Effects of Levaquin®

The Food and Drug Administration issued this alert in October 2008: "Fluoroquinolones, including Levaquin®, are associated with an increased risk of tendonitis and tendon rupture in all ages. These ruptures most frequently involve the Achilles tendon, but can also include ruptures of the shoulder, hand, biceps, and thumbs, according to the FDA. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart and lung transplants."

The FDA added the following: "Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Levaquin® should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendonitis or tendon rupture, and to contact their health-care provider regarding changing to a non-quinolone antimicrobial drug."

Despite the warning above, the FDA has determined that a large number of tendon injuries are still being reported by patients who have been prescribed and may be still taking Levaquin®.  

Tendonitis and Ruptured Tendons: An Overview

Tendons connect the muscles of your body to the bones, and are essential for proper movement and mobility. Tendonitis (or tendinitis) refers to the inflammation of a tendon, used to refer to more severe injuries to the tendon. Tendonitis can occur in other parts of the body also, and is extremely painful. Some examples are Achilles tendonitis of the heel and patellar tendonitis.

Tendon rupture refers to a torn or snapped tendon, which can cause extreme pain and  result in permanent disability. Ruptured tendons may be treated with surgery or through immobilization, as when a cast is used.

Common Symptoms of a Ruptured Tendon

According to a report from The Journal of American Board of Family Medicine, the onset of tendon rupture among patients is normally abrupt, causing extreme sharp pains and the legs to swell when walking.

The study says that even though most of the tendonitis among Levaquin® patients occurs within the first two weeks of taking the drug, tendonitis can occur in patients long after the drug’s cycle has been completed.  

Some of the symptoms of tendonitis or ruptured tendons are:

•    Bruising after injury to a tendon area
•    Sharp pain or swelling in a tendon area
•    A snap or pop in a tendon area
•    Inability to bear weight or move the affected area

If you or a loved one has been seriously injured after taking the Levaquin®, it is important that you consult with a legal professional immediately.

Do not discontinue any medication, including Levaquin®, without talking with your physician.

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