Do Not UseGemifloxacin Brand name(s): FACTIVE
(Oscient Pharmaceuticals Corp.)
Do Not
Use
All brand names are trademarks of their respected manufacturers. The information being provided below is to be considered a quick reference guide.
For complete information please view the
complete package insert at:
www.rxlist.com
PDF version of the package insert can be found at the FDA website following this link. Remember Adobe Reader is required to view this.
http://www.fda.gov/cder/foi/label/2004
A
The CD containing a copy of the FDA Briefing Package (Gemifloxacin)
Anti-Infective Drugs Advisory Committee (March 4, 2003) New Drug Application (NDA)21-158 Factive(gemifloxacinmesylate)
in which the adverse reactions to gemifloxacin were discussed is available at no
charge upon request. Send the address to which the CD is to be sent to:
fqresearch@aol.com
and indicate that you wish to receive a copy of this CD.
www.fda.gov/ohrms/dockets/ac/03/briefing/3931B1_02_FDA-Factive.pdf
Listed in Public Citizen
as a
Do Not Use drug
Numerous other, safer antibiotics are approved to treat the
same infections as this drug
Read the FDA Mandated Label Changes, October 2004,for Factive
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.
QUINOLONES MAY HAVE THE POTENTIAL
TO PROLONG THE QTc INTERVAL OF THE ELECTROCARDIOGRAM IN SOME PATIENTS. DUE TO THE LACK OF CLINICAL EXPERIENCE, GATIFLOXACIN SHOULD BE AVOIDED IN PATIENTS WITH KNOWN PROLONGATION OF THE QTc INTERVAL, PATIENTS WITH UNCORRECTED HYPOKALEMIA, AND PATIENTS RECEIVING CLASS IA (E.G. QUINIDINE, PROCAINAMIDE) OR CLASS III (E.G. AMIODARONE, SOTALOL) ANTIARRHYTHMIC AGENTS.Ruptures of the shoulder, hand, and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones. Tendon rupture can occur during or after therapy with quinolones.
Quinolones may
cause central nervous system (CNS) events including nervousness, agitation, insomnia, anxiety, nightmares, or paranoia.As with other quinolones, disturbances of
blood glucose, including symptomatic hyper- and hypoglycemia, have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic (e. g., glyburide) or with insulin. In these patients, the monitoring of blood glucose is recommended.The United States Food and Drug Administration has declined to approve gemifloxacin mesylate (Factive), a quinolone antibiotic that was under review for the treatment of respiratory tract infections. The manufacturer of the product is Glaxo Smithkline.
http://www.pharmj.com/Editorial/20010120/clinical/clinical.htmlGSK's decision to abandon Factive was also reported by The Independent of 16
April 2002 in the article 'Glaxo to abandon chest infection drug' which said the
company was to abandon development 'after side effects threatened to scupper its
chances of being allowed on the market'.
Source:
The US Food and Drug Administration has declared
gemifloxacin (Factive), the latest fluoroquinolone, ‘non-approvable’ in a letter
to manufacturer SmithKline Beecham (now GlaxoSmithKline).
The details behind the decision have not been released by the company or the
FDA; market analysts had predicted high sales on the basis of efficacy and
safety data.
Source:
Glaxo submitted Factive's NDA in December 1999, and one year later the FDA issued a non-approval letter. Glaxo is working with the FDA to determine what is necessary to gain approval. Published investigations regarding the agent's treatment effect and adverse effect profile suggest approvability.
http://www.btechnews.com/news/2001BTNs/813mm.htmPeripheral 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.
Tendinitis and tendon ruptures
may occur during treatment with quinolones, particularly in elderly patients or
when corticosteroids are being co-administered. FACTIVE should be discontinued
if tendinitis is suspected or at the first sign of pain or inflammation and the
affected limb should be rested.
In clinical studies with gemifloxacin a mean increase in QTc interval was observed (approx 5 msec).
Patients with existing or family history of glucose-6-phosphate dehydrogenase deficiency may develop haemolytic reactions during therapy.
Adequate hydration should be maintained to prevent the formation of highly concentrated urine.
Photosensitisation has been reported with the use of quinolones.
FACTIVE should not be used in pregnant or lactating women except in those cases where the potential benefit to the mother outweighs the potential risk to the foetus. Animal studies have shown adverse effects on embryo-foetal development and gemifloxacin-related material is excreted in the milk of lactating rats.
Pseudomembranous colitis has been reported with the use of broad spectrum antibiotics.
The following adverse reactions have been
associated with gemifloxacin:
Body as a Whole: fungal overgrowth
Central Nervous System/Psychiatric: headache dizziness, insomnia
Gastrointestinal:abdominal pain, diarrhea, nausea, vomiting
Laboratory Abnormalities: asymptomatic transient elevations in liver enzymes.
Skin: maculopapular erythematous skin rash. A diffuse maculopapular or erythematous skin rash was reported in some patients taking FACTIVE in clinical trials. The rash mainly occurred after one week, was generally mild to moderate and appeared to be a type IV hypersensitivity reaction. It is recommended that treatment with FACTIVE should be discontinued if a patient experiences rash, unless the opinion of the physician dictates otherwise. urticaria, pruritus
In addition, isolated cases of the following adverse effects were observed: elevated bilirubin, tendinitis, thrombocytopenia, and photosensitivity reaction.
In common with other quinolones, reversible foetal growth retardation occurred in mice, rats and rabbits. At a maternally toxic dose in pregnant rats, there was foetal malformation; this effect was not seen in other species studied.
Phototoxicity has been reported for some other quinolones. Gemifloxacin had a lower photosensitisation potential compared with some other quinolones in preclinical studies.
As with some other quinolones reversible crystal nephropathy was observed in rats. This was considered to be due to the poor solubility of gemifloxacin at the pH of rat urine.
source:
http://www.medsafe.govt.nz/Profs/Datasheet/f/Factivetab.htm