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Fluoroquinolone Use Restricted According to FDA Suggestion

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

Recent data suggests that the benefits of fluoroquinolones do not outweigh the adverse effects of the drugs for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections (UTIs) who have other treatment options – prompting the U.S. Food and Drug Administration to issue a safety alert as well as updated drug label.

The class of drugs-previously used as therapy of respiratory and urinary tract infections-includes ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin.

The news is especially troubling, as fluoroquinolones are a class of antibacterial drugs that had been used precisely for the treatment of its contraindications: acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis in those with chronic obstructive pulmonary disease (ABECB-COPD), and uncomplicated urinary tract infection.

Fluoroquinolones have been found increasingly dangerous. It is already known that these drugs can severely exacerbate the risk of tendinitis, tendon rupture, prolongation of the QT interval, and peripheral neuropathy.

In the past, this drug type has also been classified as having adverse effects on the liver. Patients may experience an acute and often severe liver damage arising within 1 to 4 weeks of starting therapy. More common side effects of the drug class include gastrointestinal disturbances, headaches, skin rash, and allergic reaction.

Most published comparative trials describe these risks among the drug class, but do not focus on the incidence of serious arrhythmias, seizures, hallucinations tendon rupture, or photosensitivity.

The current labelling already includes warnings about the risks for each of these adverse effects, as well as other central nervous system effects, Torsades de Pointes, phototoxicity, hypersensitivity, and myasthenia gravis exacerbation.

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