Levaquin Package Insert

The complete package insert, including the black box warning can be viewed at the following site:

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021721s020_020635s57_020634s52_lbl.pdf

The Black Box Warning

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Warning: Fluoroquinolones, including Levaquin, are associated with an increased risk of tendinitis and tendon rupture in all ages.  This risk factor is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart, or lung transplants.


Selected Text from the Warnings and Precautions Section

5.1 Tendonopathy and Tendon Rupture

Fluoroquinolones, including Levaquin, are asociated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achille's tendon and rupture of the Achille's tendon may require surgical repair.  Tendinitis and tendon rupture in the rotator cuff (shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported....Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders, such as rheumatoid arthritis. Tendinitis and tendon rupture have been reported in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after the completion of therapy; cases occuring 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 tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.

5.7 Peripheral Neuropathy

Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness have been reported in patients receiving fluoroquinolones, including Levaquin. Levaquin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation in order to prevent the development of an irreversible condition.