FDA Panel Says Levaquin Label Should be More Severe

A joint U.S. Food and Drug Administration panel is calling for a stronger warning label on fluoroquinolones, a family of systemic antibiotics that includes Levaquin, Cipro, and Avelox. The panel seeks label updates that more strongly emphasize serious risks, such as peripheral neuropathy.

New York, USA – December 1, 2015 /PressCable/ —

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, comments on recent updates involving fluoroquinolones, a class of systemic antibiotics that includes Levaquin (Levofloxacin), Cipro (Ciprofloxacin), Avelox (Moxifloxacin), Noroxin (Norfloxacin), Floxin (Ofloxacin), and Factive (Gemifloxacin). A U.S. Food and Drug Administration (FDA) joint panel of its Antimicrobial Drugs Advisory Committee (ADMAC) and the Drug Safety and Risk Management Advisory Committee recently called for stronger warnings to highlight serious risks, such as peripheral neuropathy, Medscape reports. Other potential side effects include tendonitis, tendon rupture, central nervous system effects, myasthenia gravis exacerbation, QT prolongation and Torsades de Pointes, phototoxicity, and hypersensitivity. The panel meeting considered the use of fluoroquinolones for treatment of acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis in those with chronic obstructive pulmonary disease (ABECB-COPD), and uncomplicated urinary tract infection. http://www.medscape.com/viewarticle/854067?src=wnl_edit_medn_wir&uac=137192SJ&spon=34&impID=888128&faf=1

Medscape reports that some panel members even called for a Black Box warning, the most serious FDA warning. In terms of voting, voting was nearly unanimous that the benefits and risks of fluoroquinolones do not support treatment of ABS, ABECB-COPD, and uncomplicated urinary tract infections, which are current approved indications. These drugs are, at best, moderately successful for treating ABS and mild ABECB-COPD. More than 30 people spoke at the meeting about adverse events they experienced following use of fluoroquinolones.

In August 2013, the FDA ordered a label update on fluoroquinolones to warn about the risk of peripheral neuropathy. At that time, the agency indicated that this nerve damage, which typically affects the arms and legs, may manifest soon after treatment starts and may become permanent. Peripheral neuropathy “may occur soon after these drugs are taken and may be permanent,” the FDA indicated. This adverse event only appeared with fluoroquinolones taken orally or by injection. According to the FDA safety alert “Symptoms include pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or the sense of body position. It can occur at any time during treatment with fluoroquinolones and can last for months to years after the drug is stopped or be permanent.” “The FDA has warned that peripheral neuropathy is a serious and potentially permanent side effect linked to the use of fluoroquinolone antibiotics, including Levaquin,” said Matthew J. McCauley, Senior Litigation Counsel at Parker Waichman. “This is only one of several risks linked to this family of antibiotic medications. The panel’s recommendation of a stronger warning label shows that use of these medications should be taken with caution. It is important for both patients and health care professionals to be aware of these risks.”

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