NEWS
10/29/1992

<TITLE>The Food and Drug Administration approves Depo Provera</TITLE>
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P92-31                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                       Susan Cruzan - (301) 443-3285

    The Food and Drug Administration today announced the approval of Depo     
Provera, an injectable contraceptive drug.
    The drug, which contains a synthetic hormone similar to the natural       
hormone progesterone, protects women from pregnancy for three months per      
injection.  The hormone is injected into the muscle of the arm or buttock     
where it is released into the bloodstream to prevent pregnancy.  It is more   
than 99 percent effective.
    "This drug presents another long-term, effective option for women to      
prevent pregnancy," said FDA Commissioner David A. Kessler, M.D.  "As an      
injectable, given once every three months, Depo Provera eliminates problems   
related to missing a daily dose."
    Depo Provera is available in 150 mg. single dose vials from doctors and   
clinics and must be given on a regular basis to maintain contraceptive        
protection.  If a patient decides to become pregnant, she discontinues the    
injections.  
    As with any such products, FDA advises patients to discuss the benefits   
and risks of Depo Provera with their doctor or other health care              
professional before making a decision to use it.
                                   -MORE-

                                            Page 2, P92-31,Depo Provera
    Depo Provera's effectiveness as a contraceptive was established in        
extensive studies by the manufacturer, the World Health Organization and      
health agencies in other countries.  U.S. clinical trials, begun in l963,     
also found Depo Provera effective as an injectable contraceptive.
    The most common side effects are menstrual irregularities and weight      
gain.  In addition, some patients may experience headache, nervousness,       
abdominal pain, dizziness, weakness or fatigue.  The drug should not be used  
by women who have acute liver disease, unexplained vaginal bleeding, breast   
cancer or blood clots in the legs, lungs or eyes.  
    The labeling advises doctors to rule out pregnancy before prescribing     
the drug, due to concerns about low birth weight in babies exposed to the     
drug.  Recent data have also demonstrated that long-term use may contribute   
to osteoporosis.  The manufacturer will conduct additional research to study  
this potential effect.  
    Depo Provera was developed in the l960s and has been approved for         
contraception in many other countries.  The UpJohn Company of Kalamazoo,      
Mich., which will market the drug under the name, Depo Provera Contraceptive  
Injection, first submitted it for approval in the United States in the        
l970s.  At that time, animal studies raised questions about its potential to  
cause breast cancer.   Worldwide studies have since found the overall risk    
of cancer, including breast cancer in humans, to be minimal, if any.
    FDA is one of the eight Public Health Service agencies within HHS.
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