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Fluoroqinolone Antibiotics Require Black Box Warning for Heart Rhythm Side Effects

. By Lucy Campbell

Fluoroqinolone antibiotics, including Levaquin, Avelox and Cipro, should have a new black box warning regarding the risk of heart rhythm problems according to Public Citizen, a prominent national watchdog group.

Levaquin, Avelox and Cipro are among the most widely used fluoroquinolone antibiotics, which are a controversial group of medications, widely used to treat a variety of infection including urinary tract infections, acute bacterial sinusitis, bronchitis linked to chronic obstructive pulmonary disease.

According to the founder of and senior advisor to Public Citizen, Dr. Sidney Wolfe, there is a large enough body of evidence to show the antibiotics are associated with heart rhythm problems. Appearing before an FDA panel convened to discuss the safety of fluoroquinolones, Wolfe said that FDA reviewer Dr. Andrew Mosholder had already called for such a warning.

The FDA advisory committee did vote in favor or stronger warnings on the drugs. However, the FDA is not bound to follow the committee’s recommendations.

Fluoroquinolone side effects reportedly include an increased risk of serious problems including peripheral neuropathy and tendon rupture. The reported link between fluoroquinolones and peripheral neuropathy has led the FDA to announce an updated warning label for the medications. In 2008, the FDA added a boxed warning to alert patients to the link between fluoroquinolones and tendon rupture.

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