News 06/05/1992 Recalling the Omniflox (Temafloxacin) Tablets

P92-16                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                       Eva Kemper - (301) 443-3285

    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 

                                            Page 2, P92-16, Temafloxacin
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.