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Fluoroquinolones Need Stronger Warnings About Side Effect Risks, Says FDA Panel

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Widely-prescribed antibiotics called fluoroquinolones require stronger warning labels that indicate serious side effect risks, a United States Food and Drug Administration (FDA) joint advisory panel said. Testimonies from patients who described the wide range of harmful side effects have spurred the FDA into action.

The agency's Drug Safety and Risk Management Advisory Committee and Antimicrobial Drugs Advisory Committee (ADMAC) met to discuss the side effects of fluoroquinolones in the treatment for several diseases such as uncomplicated urinary tract infection, acute bacterial sinusitis (ABS), and acute bacterial exacerbation of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB-COPD).

Fluoroquinolones, which include ciprofloxacin, moxifloxacin and levofloxacin, are used in treatment for the diseases indicated above but the panel was told that these drugs put patients at risk for severe side effects such as peripheral neuropathy, tendon rupture, tendonitis, myasthenia gravis exacerbation, central nervous system effects, phototoxicity, hypersensitivity, QT prolongation and Torsades de Pointes.

To confer a decision, 21 members of the panel voted whether or not fluoroquinolones were indeed safe for patients. The group had a unanimous vote concerning the lack of evidence about the use of fluoroquinolones in treating sinusitis. For ABECB-COPD, the vote was 18-2, with the former voting for insufficient evidence and with one who abstained. For urinary tract infections, the vote was 20-1.

More than 30 individuals gave their testimonies at an open public hearing about the side effects of the drug.

One of these individuals is 59-year-old Andrea Siani of Boston who said that before she took Levaquin for non-life-threatening pneumonia in March 2014, she had been in perfect health. Then came the side effects, she said. All her tendons were impaired and she suffered excruciating pain for over a year. Since then, Andrea has been using crutches for walking.

Latest study examined four similar individuals who were previously healthy but had developed side effects due to fluoroquinolones. The study concluded that the symptoms evolved into severe muscle weakness, tendinopathy, sleep disorders, cognitive dysfunction, psychiatric disturbance and peripheral neuropathy.

Meanwhile, representatives for companies who manufactured fluoroquinolones responded that these drugs are essential in treating serious infections, especially those that are fatal.

"It is important for physicians to have access to multiple options, including Cipro and Avelox, for treating bacterial infections that, if left untreated, may cause serious complications," said Dr. Jeff Alder, a representative of Bayer.

The FDA urges companies to make warnings about side effects more prominent in labels so that both patients and doctors are informed about possible risks.

Photo : Stephen Cummings | Flickr

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