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FDA ADVISES DOCTORS TO STOP USING 100 MG DOSE OF MANOPLAX

 WASHINGTON, April 26 /PRNewswire/ -- 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 1993.
 FDA is one of the eight Public Health Service agencies within HHS.
 -0- 4/26/94
 /NOTE: TV broadcasters: please use open caption for the hearing impaired./
 /CONTACT: Susan Cruzan of the Food and Drug Administration, 301-443-3285 or, after hours, 301-926-7081/


CO: Food and Drug Administration; Boots Pharmaceuticals ST: District of Columbia IN: HEA MTC SU:

MH-KD -- DC022 -- 0800 04/26/93 14:27 EDT
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Publication:PR Newswire
Date:Apr 26, 1993
Words:297
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