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Levaquin Black Box Warning

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Last Updated: 18 September 2020

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On May 12 2016, US Food and Drug Administration announced it is requiring stronger Black Box Warning for common, popular antibiotics called fluoroquinolones that include LEVAQUIN, Cipro and Avelox medications taken by more than 26 million Americans each year. The US Food and Drug Administration is advising that serious side effects associated with Fluoroquinolone antibacterial drugs generally outweigh benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options, FDA said in Drug Safety Communication. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options. Agency action came after its FDA Advisory Committee meeting in November 2015. This is not the first Warning for these drugs released by the FDA. It previously added Boxed Warnings in 2008 for tendon rupture and tendinitis and again in 2013 for permanent nerve damage called peripheral neuropathy. The new Boxed Warning advises patients and doctors that these antibiotics may cause potentially permanent damage to muscles, tendons, joints, nerves and central nervous system. In patients with minor infections such as sinusitis and bronchitis, risk outweighs benefits, FDA panel find. In these cases, other treatments are often available and agency strongly discourage doctors from prescribing them. For some patients, warnings come too late and a number of people filed lawsuits against J & J, maker of LEVAQUIN, and Bayer, maker of Cipro and Avelox.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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