The Fluoroquinolone Toxicity Research Foundation

 
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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 or by entering the drug name at Drugs@FDA
 

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.

Temafloxacin

Brand Names: Omniflox

Removed from clinical use due to severe toxicity (ie: hemolytic hepatic reactions:

WHO Comment : Temafloxacin, a quinolone antimicrobial, was introduced in 1991.  Shortly afterwards, its use became associated with severe adverse effects, including hypoglycaemia, haemolytic anaemia, renal failure, hepatitis and anaphylactic reactions. This led to its worldwide withdrawal by the manufacturer.

 OMN 22 Jun 1992 Products containing temafloxacin will not be allowed for import and marketing. (Reference: (OMNCR) Circular, 25/92, , June 1992)

WD Jun 1992 Products containing temafloxacin were withdrawn worldwide by the manufacturer, having regard to severe adverse reactions associated with their use, some of which were fatal. Reference: (HHSNS) HHS News: US Department of Health and Human Services, P92-16, ,05 June 1992)

Scientific and common names, and synonyms
 QUINOLINECARBOXYLIC ACID (+/-)-(2,4-DIFLUOROPHENYL)-6-FLUORO-1,4-DIHYDRO-7-(3-METHYL-1-PIPERAZINYL)-4-OXO-3-

C.A.S. number 108319-06-8


    The Food and Drug Administration today announced that Abbott Laboratories of Abbott Park, Ill., is voluntarily recalling the broad-spectrum anti-infective drug Omniflox (temafloxacin) tablets, and will halt all further distribution of the drug.  This action is being taken because of severe adverse events associated with the use of the drug that have been reported to the company and to FDA in the first three months of marketing. Temafloxacin was approved in late January 1992 and marketed in mid-February.  Since that time there have been approximately 50 reports of serious adverse reactions, including three deaths.  There were several cases of severe low blood sugar, especially in very elderly patients with decreased kidney function.  Among the severe reactions there were a number of cases of an unusual complex of adverse reactions consisting of hemolytic anemia (destruction of red blood cells) and other blood cell abnormalities.   Also observed were patients with kidney dysfunction, about half of which required renal dialysis.  Other patients suffered liver dysfunction.
    There has also been a substantial number of reports of allergic reactions, some of which have caused life-threatening respiratory distress.  Temafloxacin is one of a newer class of synthetic oral fluoroquinolones -- broad-spectrum antibiotics -- that are used to treat a variety of infections including lower respiratory tract infections, skin and skin structure infections, infection of the prostate and urinary tract infections.  Similar antibiotics of its class have not been reported to be   
associated with comparable numbers of serious adverse reactions.  Consumers who have the medication are advised to consult their physician and return any unused portions of the product to the place of purchase.  FDA is one of the eight Public Health Service agencies within HHS.
 

Description

None available

Removed from market due to hemolytic hepatic reactions