Levaquin, Other Fluoroquinolone Antibiotics Face FDA Review

Published on October 26, 2015 by Sandy Liebhard

Two U.S. Food & Drug Administration (FDA) advisory panels will meet next week to review fluoroquinolone antibiotics, a class of medications that includes Levaquin, Avelox and Cipro. The meeting is intended to review the risks and benefits of using fluoroquinolones to treat simple infections, such as sinusitis, bronchitis and urinary tract infections.

According to the FDA, the joint meeting of the Antimicrobial Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will be convened on November 5, 2015, from 8 a.m. to 6 p.m. at the FDA White Oak Campus in Silver Springs, Maryland. The committees will be asked to make recommendations about what regulatory actions should be taken regarding the use and safety of these antibiotics.

During the meeting, the panel members will hear testimony from patients who claim to have suffered from Levaquin side effects and other fluoroquinolone complications. These individuals include Rachel Brummert, a member of the Quinolone Vigilance Foundation, who experienced a series of tendon injuries after being prescribed Levaquin to treat sinusitis. She was later diagnosed with a neurodegenerative disorder directly related to the antibiotic she had taken.

“These antibiotics should be restricted to serious, life-threatening infections. They should never be used for simple infections, like sinusitis or UTIs because fluoroquinolones are inappropriate and ineffective for those types of infections,” Ms. Brummert said in statement issued by The Quinolone Vigilance Foundation. “The risk to patients of long-term preventable harm and life-altering adverse reactions far outweighs the benefit for infections that could easily be treated with safer antibiotics.”

Fluoroquinolone Side Effects Litigation

In recent years, Levaquin and other fluoroquinolone antibiotics have been associated with some very serious safety concerns. In 2005, a black box warning was added to the drug’s labels regarding a link to painful and debilitating tendon injuries. Since 2004, fluoroquinolone labels have included information about a potential association with permanent nerve damage and peripheral neuropathy. But in 2013, the FDA ordered fluoroquinolone manufacturers to strengthen their product labels to better reflect the rapid onset and potential permanence of these severe neurological side effects.

The FDA’s meeting will take place as scores of Levaquin lawsuits and other fluoroquinolone claims make their way through U.S. courts, many of which were filed on behalf of patients who allegedly developed serious nerve injuries and permanent peripheral neuropathy result from their use. These lawsuits accuse the drugs’ manufacturers of failing to provide adequate warnings about these potential complications to doctors and patients.

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