A Medical Letter reader has asked us to review the safety of the fluoroquinolone antibiotic levofloxacin (Levaquin – Ortho-McNeil-Janssen), which has just been approved for generic use by the FDA and has been at the center of some recent lawsuits regarding the adequacy of its safety warnings.

The FDA is requiring new warnings about peripheral neuropathy in the labeling of all oral and injectable fluoroquinolones. The potential for this class of antibiotics to cause peripheral neuropathy was first identified more than 10 years ago and a warning was added to their labels in 2004. The new warnings are based on a recent review of the FDA’s Adverse Event Reporting System (AERS) database.1The onset of peripheral neuropathy can occur rapidly, often within a few days of starting a fluoroquinolone, and in some patients the disorder may be permanent. Symptoms include pain, tingling,...

Sparfloxacin (Zagam - Rh ne-Poulenc Rorer) and levofloxacin (Levaquin - Ortho-McNeil) are the newest fluoroquinolone antimicrobials to be approved by the US Food and Drug Administration. Sparfloxacin in a once-daily oral preparation is being marketed for treatment of community-acquired pneumonia and acute bacterial exacerbations of chronic bronchitis. Levofloxacin, which is the active stereoisomer of ofloxacin (Floxin), is available for either oral or parenteral use; it is approved for oncedaily treatment of community-acquired pneumonia, acute exacerbations of chronic bronchitis,...

Trovafloxacin (Trovan - Pfizer) and its prodrug alatrofoxacin (Trovan IV) are new fluroroquinolones marketed for an unusually wide variety of infections, including oral and intravenous treatment of nosocomial and community-acquired pneumonia, acute ecerbations of chronic bronchitis, acute sinusitis, complicate intra-abdominal and pelvic infections, diabetic foot infection, uncomplicated urinary tract infection, prostatitis, cervicitis and uncomplicated gonorrhea.

View the Expanded Table: Antibiotics for Travelers' Diarrhea

The July 2003 edition of the Canadian Adverse Reaction Newsletter, published by Health Canada (the Canadian FDA), reported that the Health Canada database had received more spontaneous reports of hypoglycemia (19) and hyperglycemia (7) with gatifloxacin (Tequin) than with other quinolone antibiotics.

Cefdinir (Omnicef - Parke-Davis), a third-generation oral cephalosporin, has been approved by the FDA for treatment of acute sinusitis, otitis media, acute exacerbations of chronic bronchitis, pharyngitis, community-acquired pneumonia and skin infections. Other drugs available for these indications are reviewed in The Medical Letter Handbook of Antimicrobial Therapy, 1998.

Gatifloxacin and moxifloxacin are now available for once-daily treatment of patients with community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, or acute sinusitis.

Grepafloxacin (Raxar - Glaxo Wellcome), a once-daily oral fluoroquinolone, is now being marketed for treatment of community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, uncomplicated gonorrhea, and nongonococcal urethritis and cervicitis.

The FDA has added a boxed warning to fluoroquinolone package inserts about tendon injuries that may occur as a result of their use. Tendinitis or tendon rupture may occur rarely with systemic use of any fluoroquinolone, either while the drug is being taken or for up to several months afterwards.Fluoroquinolone-related tendon injury is rare; estimates for its incidence in the general population range from 0.14% to 0.4%. The risk is higher for patients >60 years old and for those taking corticosteroids. For patients with organ transplants, the incidence may be as high as 15%.1 A case-control...