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Tendon Rupture

Levaquin: Are Benefits Worth the Risks?


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Levaquin, also available as the generic levofloxacin, is a broad spectrum antibiotic used for treatment of bacterial infections of the lung, sinus, skin, and urinary tract of adults.

Available in varied strengths, 250mg, 500mg, and 750mg, the prescribing physician must determine the suitable strength and length of time patient must take the medication. A full course of therapy is necessary to eliminate the bacteria causing the infection.

Levaquin is an effective treatment for a wide variety of infections; unfortunately, it has severe side effects that patients are not always aware of. The main component of this antibiotic is fluoroquinolone a fluorinated type of quinolone compound a chemical that puts users at significant risk for tendonitis and tendon rupture. Patients over 60 years of age, those taking corticosteroids, and heart/kidney/lung transplant recipients are at substantially higher risk.

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Other serious side effects include severe and possibly fatal allergic reaction. This reaction may take place after initial dose or after several doses. Hives, skin rashes, or any other signs of allergic response should be reported to healthcare providers and drug use immediately discontinued. Levaquin patients are also at increased risk for liver damage.

Central nervous system adverse effects may include depression, confusion, insomnia, and anxiety. There is also a risk of nerve damage, resulting in pain, burning, or numbness in extremities. Abnormal heart rhythms and blood glucose instability have also been noted with Levaquin use.

The United States Food and Drug Administration (FDA) has compelled Ortho-McNeil-Janssen Pharmaceuticals to utilize a black box warning on Levaquin. A black box warning appears on the package insert for certain drugs. The "black box" refers to the bold black outline surrounding the warning. This type of warning indicates that the drug carries significant risk of extremely serious adverse effects. This is the highest level warning required by the FDA.

The black box warning was added to call public attention to the high risk of tendonitis or tendon rupture with use of Levaquin. In addition to Ortho-McNeil-Janssen Pharmaceuticals, Bayer Healthcare Pharmaceuticals, Merck & Co., and others have been compelled to add the warning to their fluoroquinolone based drugs. The FDA has been studying the relationship between these drugs and tendonitis or tendon rupture for several years. Prior to the black box warning, there was a general warning on patient materials. The new warning is more prominent and indicates the severity of the risk.

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If you have taken Levaquin or levofloxacin and have suffered from severe adverse effects, contact your healthcare provider and lawyer immediately.

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