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May 12, 2016: FDA Requires Label Change to Levaquin Side Effects

Levaquin Side Effects

In line with a string of Safety Communications from the U.S. Food and Drug Administration (FDA) regarding Levaquin, and all brands of fluoroquinolones, the FDA has issued a warning against using the drug for “uncomplicated infections”. Levaquin is a type of fluoroquinolone, and is used to fight bacteria in the body. Other fluoroquinolones may be known under the brand names Avelox and Cipro.

Conservative Use of Levaquin for UTIs, Sinusitis, Bronchitis

According to the FDA, the risks associated with taking Levaquin antibacterial drugs are too severe to justify using the drug to treat sinusitis, bronchitis, and uncomplicated urinary tract infections. The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients who have other treatment options. For patients with sinusitis, bronchitis, and uncomplicated urinary tract infections, fluoroquinolone should be reserved for those who do not have alternative treatment options. The danger of Levaquin involves possible disabling and potentially permanent serious side effects; these side effects can occur simultaneously, and may involve the tendons, muscles, joints, nerves, and central nervous system.

FDA Action To Require Conservative Use of Levaquin

shutterstock_98575991The FDA provided the following approach to this newly declared risk: “The drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information.”

Other Levaquin Side Effect FDA Label Changes

This is not the first Safety Communication regarding fluoroqinolone. As of July 8, 2008, the FDA has alerted doctors and patients of the increased risk of developing tendinitis and tendon rupture associated with systemic use of quinolone antibiotics like Levaquin. On August 15, 2013, the FDA required a label change to address levaquin nerve damage risk. On November 5, 2015, a watchdog group demanded new labeling to address Levaquin cardiac arrhythmia side effect.


Attorney Eric Weinberg has represented thousands of individuals injured by dangerous, defective, or mislabeled medications, including for example, Vioxx, Pradaxa, Baycol, Yaz, contaminated Blood Clotting Factors, and Ortho Evra. We have obtained over $800 million on behalf of the firm’s personal injury clients.

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