*This is an archive page. The links are no longer being updated.
1993.04.26 :  New Heart Drug Manoplax (Flosequinan)
                      
Contact: Susan Cruzan -- (301) 443-3285 (Home) - 301-926-7081
April 26, 1993
     
     The Food and Drug Administration today recommended that at the
present time doctors stop using a 100 milligram per day dose of the
new heart drug Manoplax (flosequinan).  
     This recommendation is based on the results of a controlled
trial comparing Manoplax and a placebo that showed a significantly
increased risk of death in patients taking 100 mg. of the drug. 
Increased mortality has not been seen in patients given 75 mg. of
the drug, and both the 75 mg. and 50 mg. doses may still be used.
     Patients on Manoplax should not alter their use of the drug
before consulting with their physicians.
     The study, being conducted by the manufacturer, Boots
Pharmaceuticals, has been evaluating the effects of two doses of
the drug on the survival of patients with severe congestive heart
failure.       
     A Dear Doctor letter has been prepared by Boots that will
provide information about this development to medical
practitioners.  This letter is being sent by overnight mail to
selected cardiologists and internists.  A mailgram, detailing the
same information, is being sent to pharmacists, hospital pharmacies
and primary care physicians.  Additional information is also
available from the company.   Manoplax was approved by FDA on Dec.
30, 1992, for the management of congestive heart failure in
patients who do not respond to or cannot tolerate certain other
medications.  It was released for marketing in late March *This is an archive page. The links are no longer being updated.
1993.  
FDA is one of eight Public Health Service agencies in HHS.
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