Fluoroquinolones should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria, in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication, the use of drugs within this class is unlikely to provide benefit to the patient and increases the risk of the development of serious and irreversible adverse drug reactions. As with any potent antimicrobial drug, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during therapy. The FDA has recently added new warnings to the drugs found within this class bringing the following to the attention of both the patient and the physician:

Recent label changes to all of the fluoroquinolones include warnings regarding:

A review of the various letters sent to the manufacturers of the drugs within this class, appears to indicate that the FDA considers these adverse drug reactions to be class effects and not limited to a specific fluoroquinolone. Neggram, (Nalidixic Acid, the ‘Father’ of the quinolones) introduced in the sixties, appears to have undergone the most extensive revisions with the newer drugs receiving the minimal of warnings. Several of the label changes found within some of the drugs currently in clinical practice failed to state that Peripheral Neuropathy is an irreversible condition or that the drug should be discontinued upon the manifestation of Peripheral Neuropathy. The reasoning behind this discrepancy is difficult to determine. One would think if indeed these serious adverse reactions were a class effect then all drugs within this class would receive identical warnings. However this does not appear to be the case. Most striking is the total absence of any of these warnings for the eye and ear drops containing these drugs commonly used in clinical practice within the pediatric population.

Within the package insert for Ciprofloxacin regarding Peripheral neuropathy we find the following:

"Peripheral neuropathy: Rare cases of sensory or sensorimotor axonal polyneuropathy

affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and

weakness have been reported in patients receiving quinolones, including Ciprofloxacin.

Ciprofloxacin should be discontinued if the patient experiences symptoms of neuropathy

including pain, burning, tingling, numbness, and/or weakness, or is found to have deficits in

light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength in

order to prevent the development of an irreversible condition."

Yet the package inserts for Moxifloxacin, Bayer’s replacement for Ciprofloxacin (as Ciprofloxacin has gone generic) we find the following warning devoid of the statement "…in order to prevent the development of an irreversible condition." As well as the advice that the patient should discontinue such therapy upon manifestation of Peripheral Neuropathy:

"Peripheral neuropathy: Rare cases of sensory or sensorimotor axonal polyneuropathy affecting

small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have

been reported in patients receiving quinolones."

Within the package insert for Ciprofloxacin regarding Tendon Effects we find the following which appears to be consistent amongst all the fluoroquinolones:

The following warnings are also proven to be inconsistent amongst the various drugs within this class:

Caffeine accumulation

Pseudomembranous colitis

QTc interval prolongation