NEWS
11/16/1992

<TITLE>Frequent or persistent cases of vaginal fungal infections or vaginal candidiasis may sometimes be an early warning of HIV infection</TITLE>
<PRE>
P92-33                                          Food and Drug Administration
FOR IMMEDIATE RELEASE                           Monica Revelle - (301) 443-4177

    The U.S. Public Health Service today advised women that frequent or       
persistent cases of vaginal fungal infections known as "yeast" infections or  
vaginal candidiasis may sometimes be an early warning of HIV infection.
    HHS Assistant Secretary for Health James Mason, M.D., who heads the       
Public Health Service, said most of the 13 million cases of vaginal           
candidiasis that occur annually do not have HIV as an underlying cause.       
"Pregnancy, diabetes, contraceptive pills and antibiotics are commonly        
linked to these fungal infections," he said.
    "But any woman at risk for AIDS," Dr. Mason continued, "should be aware   
of the possibility that recurrent or stubborn cases of vaginal candidiasis    
sometimes may be an early sign of infection with the human immunodeficiency   
virus, HIV, that causes AIDS -- and should check with a doctor.  That is the  
purpose of this statement -- and of new labeling for nonprescription drugs    
for vaginal candidiasis."
    According to recent studies, recurrent or stubborn cases of vaginal       
candidiasis are the most frequent initial clinical manifestation of HIV       
infection in women.  One study showed that of women diagnosed with HIV-       
caused immunosuppression, 38 percent suffered recurring or persistent cases   
of vaginal candidiasis as their first symptom.
                                   -MORE-

                                                  Page 2, P92-33, Candidiasis
    "Having this information in hand," said Food and Drugs Commissioner       
David A. Kessler, M.D., "the agency has requested that manufacturers of       
nonprescription drugs for vaginal candidiasis include a new label warning     
that women who may have been exposed to HIV infection and who experience      
recurrent or persistent cases of vaginal yeast infections seek professional   
medical attention promptly."
    Miconozole nitrate, marketed under the name brand Monistat-7, and         
clotrimazole, marketed as Gyne-Lotrimin, Mycelex-7 and FemCare, are sold      
without prescription for treatment of vaginal candidiasis in patients who     
have had a previous episode of vaginal candidiasis diagnosed by a             
physician.  The labeling of these products already states that recurrent      
infections may result from hormonal changes or use of oral contraceptives or  
antibiotics.
    The additional warning will state: "In women with frequently recurrent    
vaginal yeast infections, especially infections that don't clear up easily    
with proper treatment, the vaginal yeast infections may also be the result    
of serious medical conditions, including infection with HIV, that can damage  
the body's normal defenses against infection."
    "Women should be made aware through all available sources that if they    
are experiencing recurrent vaginal yeast infections within a two-month        
period or if their infections don't clear up with proper medical treatment,   
they should see their doctor for professional diagnosis and treatment," Dr.   
Kessler said.  "In view of the growing epidemic of AIDS among women, it is    
important that they be alert to possible early HIV infection."
                                   -MORE-

                                                  Page 3, P92-33, Candidiasis
    Women who need further information on risk factors for HIV infection or   
testing for HIV infection should contact their physician or the Centers for   
Disease Control and Prevention National AIDS Hotline at 1-800-342-AIDS.       
Separate CDC hotline numbers are also available for Spanish speaking persons  
(1-800-344-7432) and for the hearing impaired, (TDD 1-800-243-7889).
    FDA and and CDC are agencies of the Public Health Service within HHS.

                                    ###
</PRE>