FDA
TALK PAPER

T97-11                          Susan Cruzan:     301-443-3285
Feb. 24, 1997                   
                                Consumer Hotline: 800-532-4440

                                 

      FDA CALLS FOR APPLICATIONS FOR EMERGENCY USE OF ORAL 
                         CONTRACEPTIVES
     
     FDA has published a Federal Register notice requesting that
manufacturers submit supplemental new drug applications for
emergency use of oral contraceptives.  This use of oral
contraceptives, known as emergency contraception, is intended to
prevent pregnancy in women who have had unprotected sexual
intercourse.  Oral contraceptives used for this purpose are often
referred to as the morning after pill.  
     The agency issued this notice because it concluded, on the
basis of current scientific evidence, that certain oral
contraceptives approved for daily use are safe and effective as
emergency contraceptive pills.  Approval of this indication would
allow information on appropriate treatment regimens to be added to
the labeling for physicians and patients alike.  The following may
be used to respond to inquiries.
     Oral contraceptives were first approved in the l960's.
Although many versions of oral contraceptives containing an
estrogen and progestin are available in the United States, no 
sponsor has submitted a new drug application for use of these 
products as emergency contraceptives.  As a result, no oral
contraceptives are labeled or promoted for emergency use although
individual physicians may prescribe them for this purpose as part
of their medical practice.  
      Numerous studies have shown that specific regimens consisting
of higher doses of oral contraceptives containing
ethinyl estradiol and norgestrel or levonorgestrel can be used to
prevent conception when other contraceptives fail or when no
contraception is used.  Four treatment regimens have been found to
be safe and effective for this indication.  
      One of the regimens, first described in l974 by Professor
Albert Yuzpe of Canada, consists of two tablets, each containing
ethinyl estradiol and norgestrel, taken within 72 hours after
unprotected intercourse; a second identical dose follows 12 hours
later.  (The other three regimens consist of 4 tablets initially,
followed by 4 tablets, 12 hours later.)  When used in this manner,
the treatment is 75 percent effective in preventing pregnancy. 
These regimens have been widely used over the past two decades by
hospital emergency rooms, reproductive health clinics, and
university health centers. 
     In November l994, the Center for Reproductive Law and Policy
petitioned the agency to direct sponsors of certain oral
contraceptives to amend their labeling to include information on
the use of these products for postcoital emergency contraception. 
Although FDA denied the petition, the agency convened a public 
meeting of its Reproductive Health Drugs Advisory Committee to
discuss the scientific issues.  At that meeting, held June 28,
l996, the committee unanimously concluded that four specific
treatment regimens are safe and effective.
     Although emergency contraception is not as effective as proper
use of a regular contraceptive method, it substantially reduces the
chances of becoming pregnant after unprotected sexual intercourse. 
Risks, contraindications, and warnings for the emergency use of an
oral contraceptive would be similar to those for oral
contraceptives prescribed for daily use.  About half the women who
take the emergency contraceptive regimen have temporary nausea.  
     In the Federal Register notice, the agency said that it is
prepared to accept applications based on the available evidence. 
FDAþs action is part of its continuing efforts to increase the
information available to patients and physicians by making "off-
label" use of approved drugs part of the products' official
labeling.
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