FDA Announces Levaquin Risks Outweigh Benefits

. By Jane Mundy

The FDA today issued a new warning for Levaquin and other fluoroquinolones, adding that side effects of the antibiotic medication “generally” outweigh its benefits.

The FDA warning came almost a year after an investigation by NewsNet5. Its 5 On Your Side program reported that an FDA database comprised “at least 3,000 patients whose death had been linked to the drug and another 200,000 complaints of side effects including kidney infections and nerve damage.”

Johnson & Johnson, the Levaquin maker, is also facing a federal racketeering lawsuit. While some pundits and attorneys might consider this claim frivolous and politically motivated, attorney Shezad Malik says that J&J is facing more serious claims. “Up to 500 Levaquin lawsuits have been filed in the federal court system claiming severe nerve damage,” says Malik. “These cases are MDL’d [part of the multidistrict litigation] for pre-trial discovery.”

While the FDA warning came too late for many consumers, Malik adds that Johnson & Johnson failed to warn consumers of such risks. The agency says side effects can include damage to tendons, muscles, joints, nerves and the central nervous system, and it continues “to find an association between fluoroquinolone antibiotic use and disabling peripheral neuropathy,” according to the Wall Street Journal (May 12).

The WSJ reported that the FDA’s decision “comes after a study of the issue by the FDA’s Office of Surveillance and Epidemiology, which concluded as early as 2013.” At that time the agency did issue a public warning but didn’t go so far as to slap a boxed warning on the fluoroquinolones.

In its defense, Johnson & Johnson stated that Levaquin has been on the market for more than 20 years, and more than 36 million prescriptions for fluoroquinolones were written in 2014 alone. But both attorneys and Public Citizen, the non-profit consumer rights advocacy group, show that tendon disorders - mainly from Levaquin - were first reported in 1997. By 2005, about 800 cases had been reported by Public Citizen.

Meanwhile, Dr. Malik - who is also a cardiologist - is investigating the risk of aortic aneurism. “In October 2015, JAMA [The Journal of the American Medical Assocation] released a study showing that the fluoroquinolones can cause damage to the aorta by dissection, or tears, and aneurysms, or enlargement. Both conditions can be fatal.”

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