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November 5, 2015: Watchdog Group Demands New Labeling to Address Levaquin Cardiac Arrhythmia Side Effect

According to Public Citizen, a prominent national watchdog group, the manufacturers of Levaquin and other fluoroqinolone antibiotics need to revise the labeling of these drugs to include a strong warning of a possible cardiac arrhythmia side effect. Dr. Sidney Wolfe, founder of and senior advisor to Public Citizen, spoke in front of the U.S. Food and Drug Administration’s (FDA) Advisory Committee on November 5, 2015, to testify to the large body of evidence showing the relation between these antibiotics and heart rhythm problems.

Public Citizen testified in order to push the FDA to require fluoroqinolone antibiotic drug manufacturers to include a strict “Black Box Warning” of the possible side effect of cardiac arrhythmia on the drugs’ labeling. Dr. Wolfe cited FDA reviewer Dr. Andrew Mosholder, who had recommended a labeling change to Levaquin and other fluoroqinolone antibiotics to emphasize the risk of cardiac arrhythmia in a 2008 review of the drug.


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Dr. Mosholder’s Comments on Levaquin Cardiac Arrhythmia Side Effect

In his contribution to the FDA’s 2008 review of Levaquin, Dr. Andrew Mosholder reports that “some fluoroquinolones, including LEVAQUIN®, have been associated with […] cases of Cardiac Arrhythmia”.
He continues on to recommend that “the impact of arrhythmogenic effects on the risk-benefit balance for nonserious infections needs to be considered.”

Information on Levaquin Cardiac Arrhythmia Side Effect

Levaquin, along with Avelox and Cipro, are the most commonly prescribed fluoroquinolone antibiotics, used to treat a variety of infection such as urinary tract infections, acute bacterial sinusitis, and bronchitis. Another complaint of Citizen Action is that these drugs are prescribed far too frequently, often before other, less risky avenues for treatment are explored.

Along with possible cardiac arrhythmia, fluoroquinolone may lead to other severe side effects, such as peripheral neuropathy and tendon rupture. The risk of these two serious conditions have resulted in FDA-ordered labeling changes in 2008 and 2013, respectively.

A black box warning is the strictest warning put in the labeling of prescription drugs by the FDA when there is reasonable evidence of an association of a serious hazard with the drug. As of today, there is no “Black Box Warning” on Levaquin, just a smaller, less urgent warning that, “Levofloxacin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.”

Public Citizen’s Findings Regarding Levaquin Cardiac Arrhythmia Side Effect

At the November 5, 2015 Joint Meeting of the Antimicrobial Drugs and Drug Safety and Risk Management Advisory Committees, Dr. Wolfe, representing Public Citizen, presented the information the group used to conclude that Levaquin was being overprescribed and needed new labeling.

The findings of this study concluded that:
• 81% of fluoroqinolone antibiotic prescriptions were inappropriate
• 53% of fluoroqinolone antibiotic prescriptions were considered inappropriate because another agent was considered first line
• 33% of fluoroqinolone antibiotic prescriptions were inappropriate because there was no evidence of infection based on the clinical evaluation or diagnostic studies
• 14% of fluoroqinolone antibiotic prescriptions were inappropriate due to insufficient evaluation of the patient
• Warnings buried in the label are not likely to be noticed or heeded

Again Wolfe cited FDA reviewer Dr. Andrew Mosholder to explain that “a black box warning for the well documented QTc prolonging effects of fluoroqinolone antibiotic is needed,” as the more antibiotics are prescribed unnecessarily without proper heed of the risks, the more cardiac arrhythmia side effects will present themselves.

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.

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