Answers
05/22/1990

<TITLE>Accutane Update</TITLE>
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                               ACCUTANE UPDATE
    Accutane -- a prescription drug approved in l982 for severe,
recalcitrant cystic acne -- on May 2l underwent its eighth review by FDA's
Dermatologic Drugs Advisory Committee (jointly with FDA's Fertility and 
Maternal Health Advisory Committee on this occasion).  The following may be 
used to answer questions. 
    The drug, a vitamin A derivative manufactured by Hoffmann-La Roche of 
Nutley, N.J., is highly effective therapy for a serious and debilitating
form of acne that causes cysts, scarring and disfigurement.  When it was
approved, FDA knew it had a potential to cause birth defects and, as a
result, approved labeling that warned the drug should not be used in
pregnant women. 
    Nevertheless, beginning in l983 there were reports of severe human birth
defects associated with the drug.  Subsequently, efforts to prevent Accutane
pregnancy exposures and birth defects were undertaken by the manufacturer 
and FDA.  The latest and most extensive effort aimed at eliminating birth 
defects, referred to as the "Pregnancy Prevention Program for Women on
Accutane" was initiated by the manufacturer in late l988, although it was 
not fully implemented until mid-l989.  This program was recommended by the
advisory committee because of concerns about continuing reports of pregnancy
exposures and birth defects.
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    The "Pregnancy Prevention Program" included unprecedented educational 
efforts and restrictions:  The drug is sold only in blister packs that
include warnings and pictures as a part of the package; there are consent 
forms provided to be signed by patients stating that they understand the
serious risk of birth defects and pregnancy prevention kits for doctors that
provide additional educational materials and reimbursement for a patient
ob/gyn consultation; and the label requires that the drug be prescribed only
after female patients have had a negative pregnancy test.  The voluntary
plan also included the initiation of an epidemiological study to determine
the effectiveness of the overall program in reducing Accutane pregnancy 
exposures and birth defects.
    One infant has been reported born with defects in l990, four for l989 
and three for l988, compared to 10 for 1987 and 12 for 1986.  FDA asked the 
two advisory committees to evaluate the effectiveness of current efforts to 
curb drug/pregnancy exposures and birth defects.  The committees were also
asked if additional measures are necessary. 
    The committees concluded that they believe the manufacturer has made a
very strong effort to inform physicians and patients of the risk associated 
with Accutane.  They said that recent data on the effectiveness of the
latest efforts were limited and that by l99l, a better judgment of the
program's success would be possible.
    The committees also recommended that l) educational materials should
further emphasize the importance of an initial pregnancy test to ensure that
women of child-bearing potential are not pregnant when Accutane is begun, 2)
the importance of informed consent forms should be emphasized and the form
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                                            Page 3, Accutane Update, T90-25 
should be made available in numerous languages, 3) counseling with
gynecologists or other professionals in pregnancy prevention should be made 
available and emphasized, and 4) that a program be designed by the
manufacturer to ensure that patients return all left-over medications they
may have so that they will not take Accutane without a dermatologist's
supervision.
    FDA will take under consideration the committees' recommendations and 
decide what steps will be taken.
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