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Tendon Rupture

Levaquin Earns Black Box Warning from FDA for Serious Adverse Effects


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Ortho-McNeil-Janssen Pharmaceuticals, a division of Johnson & Johnson (J&J), manufactures the drug levofloxacin under the brand name Levaquin.

Levaquin is a broad spectrum antibiotic used for treatment of urinary tract infections, upper respiratory infections including pneumonia, and skin infections in adults. The US Food and Drug Administration (FDA) approved Levaquin for use in treatment of bacterial infections in 1996. After years of lobbying by patients and advocates most notably Public Citizen, the FDA finally ordered the pharmaceutical company to include the black box warning on all information for prescribing physicians and patients.

Black box warnings are notices on drug packaging and informational materials that indicates the potential for severe and dangerous adverse effects. The "black box" refers to the bold black line surrounding the information. By presenting the information in this way, it becomes highly visible and draws attention to the fact that there is significant risk in taking the medication. Black boxed medication administration should be carefully weighed against the risk factors involved in potential adverse effects.

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A black box warning is the most stringent warning the FDA can enforce. This warning requires J&J to prominently feature the following information and outline it in a bold, black box: "WARNING: Fluoroquinolones, including LEVAQUIN, are associated with an increased risk of tendonitis and tendon rupture in all ages. The risk 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." This information is directly below the drug name and forms available and FDA approval date.

After 12 years on the market, thousands of patients have suffered extremely painful tendon ruptures and severe tendonitis as a result of Levaquin use. Is the black box warning enough? Currently, J&J and Ortho-McNeil-Janssen Pharmaceuticals are facing a multidistrict litigation proceeding. Hundreds of reported cases of tendon injury related to Levaquin use have been brought to the legal system in hopes of compensation for devastating injury and pain. There are those who say that the risk of tendon rupture is too great and the FDA should take action and recall the drug so that is removed from pharmacies.

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For now, the black box is in place and physicians and patients are being warned of the possible risks in prescribing and taking Levaquin. If you or someone you know took Levaquin prior to the black box warning and suffered a tendon injury, please seek legal assistance.

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