Gemifloxacin (Factive) approval denied by the FDA due to severe side-effects such as severe rashes and toxicity. (circa 12/2000)

Six YEARS later the FDA now believes that Gemifloxacin (Factive) should be studied further because of serious skin reactions associated with its use.

When compared with other antibiotics used to treat minor infections, the incident of serious rashes has Food and Drug Administration officials concerned about the safety of the drug, Factive or gemifloxacin.

Understanding the Adverse Drug Reactions Associated with Fluoroquinolone Therapy QUINOLONE ANTIBIOTICS TOXICITY. A SUMMARY OF CLOSELY FOLLOWED CASES written by T. Boomer 2003 (includes recent updated version, 2006)

New warning labels added to the fluoroquinolones regarding Peripheral Neuropathy (irreversible nerve damage), Tendon Damage, Heart Problems (prolonged QT Interval / Torsades de pointes), Pseudomembranous colitis, Rhabdomyolysis (muscle wasting), Steven Johnson Syndrome, as well as concurrent usage of NSAIDs.

Fluoroquinolones are shown to be capable of DNA Damage, TOXIC to human cells and inhibiting DNA replication, as well as a number of abnormal eucaryotic cellular responses being observed with these compounds. (1990)
"...there are reports of in vitro cytogenetic abnormalities associated with some quinolones as well as inhibitory effects on DNA replication in lymphocytes..."

Spontaneous Tendon Rupture and Severe Tendinitis associated with fluoroquinolones

On February 16, 2006, the manufacturer of gatifloxacin announced that the drug’s label would change. According to a Food and Drug Administration (FDA) press release, “Since the approval of gatifloxacin in 1999, there have been rare cases of life-threatening events reported globally in patients treated with the drug."  David Jurrlink, M.D., one of the original authors of "Outpatient Gatifloxacin Therapy and Dysglycemia in Older Adults" stated "Speaking as a clinician, I would NEVER prescribe this drug."   Sidney Wolfe of Public Citizen stated "This represents a unique danger in the absence of a unique benefit...This is more than enough reason to think about petitioning the Food and Drug Administration to BAN this drug, and we probably will." 
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Additional Articles concerning Tequin's removal

Dear Health Care Professional Letter issued by Bristol-Myers Squibb (BMS) Canada, following discussions with Health Canada, regarding the Adverse Drug Reactions associated with the use of TEQUIN* (gatifloxacin). December 19, 2005

Additional articles regarding Tequin's new warnings

In a double-blind evaluation of oral fleroxacin, Adverse Reactions developed in 66 (84%) of 79 individuals, and severe reactions arose in 38 (48%). Most frequent were central nervous system reactions (70%), insomnia (49%); gastrointestinal reactions (39%) and photosensitivity reactions (10%) were also common. Development of any reaction (central nervous system reactions, insomnia, and severe intestinal reactions) was dose related. (circa 1989)

Levofloxacin 750 mg QD for five days for treatment of acute bacterial exacerbation of chronic bronchitis: The prevalence of treatment-emergent adverse events was 42.1 % in patients who received levofloxacin.

Among 386 anaphylaxis cases, 84 (22%) referred to antibiotics.  Among these antibiotics, 52/84 cases (62%) referred to quinolones; In our investigation
Quinolones accounted for a relevant number of anaphylaxis cases among the group of antibiotics.

Severe vision damage after possible Ciprofloxacin induced T.E.N.S.
 

Toxicity Profiles for the fluoroquinolone and quinolone chemotherapeutic  agents

Ciprofloxacin
Brand Names: Proquin XR, Cipr, Ci[proHC, Ciloxan Opht, Baycip, Cetraxal, Ciflox, Cifran, Ciplox, Ciprobay, Quintor
 

Trovafloxacin
Brand Names: Trovan
Removed from clinical use due to severe toxicity (i.e. hepatic reactions)