OFF LABEL USAGE OF THE QUINOLONES

Adverse events associated with levofloxacin   "We studied a case series of 17 individuals...Adverse events including those that affect the central nervous system, skin and musculoskeletal systems, as well as elevated liver enzymes, all occurred in less that 2% of patients prescribed levofloxacin during clinical trials. The incidence of adverse effects observed in our patients (100%) greatly exceeded that expected." (PDF File) Adobe Reader Required (circa 2002)

Fluoroquinolones were the most commonly prescribed class of antibiotics for adults in 2002

Substituting or adding fluoroquinolones to established first-line antituberculous drug regimens gives no additional benefit

Antimicrobial Drug Prescribing for Pneumonia in Ambulatory Care
Of note, fluoroquinolone use in the 18- to 44-year age group more than doubled from 2000 to 2002 (14% to 30%).Among fluoroquinolones prescribed over all years of the study, 74% were for levofloxacin; 51% of levofloxacin prescriptions were considered inappropriate-These findings suggest that those prescribing antimicrobial drugs may be increasingly using fluoroquinolones as a "one-size-fits-all" regimen without accounting for differences due to age and other risk factors

ODS POSTMARKETING SAFETY REVIEW
Consult: One-Year Post Pediatric Exclusivity Postmarketing
Adverse Events Review  Ciprofloxacin
NDA: 19-537, 19-847 PDF File

(In summary, in the 13-month period of review the 17 unique pediatric cases showed mostly labeled hematological, musculoskeletal, allergic/hypersensitivity, and CNS events...  because one report was concerning due to the patient requiring a wheelchair after developing drug associated symptoms...)

Switching Fluoroquinolones in Patients with Neutropenia May Increase Infection Risks

The use of Factive (Gemifloxacin) in elderly persons is not strongly recommended in light of the associated risks and the fact that it does not offer any benefit over other fluoroquinolones.

Yet another pediatric trial: Quinolones no better than standard antibiotics when treating treating typhoid and paratyphoid fever with Norfloxacin having more clinical failures than other fluoroquinolones. 

Avoiding Achilles tendon ruptures in the elderly - Literature Monitor Clinician Reviews, Oct, 2003
It has now been confirmed that quinolones, the most frequently prescribed antibacterial agents, increase the risk of Achilles tendon rupture in elderly patients, according to van der Linden et al


Fungal Infections Associated with Ofloxacin.  "An increase in incidence of fungal infections of the ear were found in the period after widespread use of ofloxacin began."

Antibiotic Treatment Does Not Reduce Risk of Secondary Cardiac Events

Fluoroquinolone prescribing in the United States: 1995 to 2002.

Antibiotics not effective for many coughs Medical Study News Published: Wednesday, 22-Jun-2005

FDA officials called on Alcon to "cease the dissemination" of misleading information regarding their antibiotic ear drops, called Cipro HC Otic., and told company officials to respond to the warning by May 11, 2005

August 2004, Moxifloxacin (Avelox) when prescribed for Community Acquired Pneumonia, Chronic Bronchitis, Acute Bacterial Sinusitis offers no compelling advantages over established treatment.  Claims that oral moxifloxacin provides "rapid relief from chest infections" are unsubstantiated.

Of 100 total patients, 81 received an FQ for an inappropriate indication. Of the 19 patients who received an FQ for an appropriate indication, only 1 received both the correct dose and duration of therapy. ( 1% received the appropriate drug at the appropriate dose, hence 99% of the prescriptions were in error)

Antibiotic treatment does not help sore throats.  British Medical Journal N0 7104 Volume 315, August 9, 1997

Antibiotics do not improve sinusitis symptoms, study shows.  Lancet March 8, 1997 / World Health Report, 1996 World Health Organization Geneva Switzerland May 1996

Antibiotic use in treating bronchitis is unnecessary and risky  The Journal of Family Practice 1997;44(3):261-265

Antibiotics useless on cold viruses, the uncontrolled and inappropriate use of antibiotics. 

The overuse of antibiotic such as happened with children suffering from otitis media has given rise to a breed of super bacteria which are resistant to antibiotics entirely.
Source: "Antimicrobials for acute otistis media; A review from the International Primary Care Network". British Medical Journal July 5, 1997.  "Penicillin resistant streptococcus pneumoniae found in chronic otitis media with effusion." American Academy of Otolaryngology Sept. 2, 1997
(Seven years later the FDA has approved Clinical Trials for the Pediatric use of fluoroquinolones to treat Otitis Media in children as young as six months old)

Antibiotics' Futility Against Bronchitis Confirmed

Combining the Gonzales and Evans study we find about 24 million prescriptions for an antibiotic in which 90% (21.6 million patients) would receive no greater benefit than if they had taken vitamin C.

Cipro, Related Antibiotics Over-Prescribed...A new study heightens concerns that Cipro and related broad-spectrum antibiotics known as fluoroquinolones are being over-prescribed...

Gatifloxacin and moxifloxacin have no proven clinical advantages over other fluoroquinolones, macrolides, or amoxicillin