FDA amps up black-box warnings on antibiotic class that includes J&J's Levaquin, Bayer's Cipro

The FDA stepped up warnings on antibiotics like Johnson & Johnson’s Levaquin, adding long-term risks to the drugs’ current black-box warning. The agency also advised using the drugs only for serious infections.

The new black boxes apply to fluoroquinolone antibiotics, a class that includes the Bayer drug Cipro, Merck & Co.’s Avelox and other brands, as well as generics.

The class of meds already carries a boxed warning that the drugs increase the risk of tendonitis and tendon rupture--added to the label in 2008--and cautionary language about the risk of serious nerve damage.

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Fluoroquinolone makers have faced thousands of lawsuits from patients who claim that their injuries were caused by the drugs. J&J alone faced 3,400 lawsuits over Levaquin’s links to tendon problems and settled many of those cases. Since then, patients have sued over Levaquin’s potential to trigger peripheral neuropathy. And in January, another group of patients sued, claiming that J&J deliberately mislabeled and misbranded Levaquin, playing down harmful side effects for its own financial gain.

J&J says it stands by its handling of the drug and its safety risks.

"We … believe our actions regarding the medicine have been appropriate, responsible and in the best interests of patients," the company told FiercePharma earlier this year. "[W]e continually monitor the safety and efficacy of all our medicines and, in cooperation with the U.S. FDA and other health authorities, we update our product labels with new information so doctors and patients can make informed decisions."

That lawsuit came a couple of months after an FDA safety review found that fluoroquinolone meds are associated with disabling side effects that can happen as early as several hours after treatment begins, or weeks later--and can be permanent. In Tuesday’s announcement of the stepped-up warnings, the agency said those potential injuries could affect tendons, muscles, joints, nerves and the central nervous system.

The drugs shouldn’t be used for sinus infections, bronchitis or urinary tract infections unless patients have no other options, the FDA says. For more serious illnesses--including anthrax, plague and bacterial pneumonia--the drugs’ benefits outweigh their risks, the agency said.

- read the FDA’s announcement

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