CONTRAINDICATIONS
AND WARNINGS
Accutane must not be used by females who are pregnant.
Although not every fetus exposed to Accutane has resulted in a deformed
child, there is an extremely high risk that a deformed infant can result
if pregnancy occurs while taking Accutane in any amount even for short
periods of time. Potentially any fetus exposed during pregnancy can be
affected. Presently, there are no accurate means of determining, after
Accutane exposure, which fetus has been affected and which fetus has not
been affected.
Major human fetal abnormalities related to Accutane
administration in females have been documented. There is an increased
risk of spontaneous abortion. In addition, premature births have been
reported.
Documented external abnormalities include: skull abnormality;
ear abnormalities (including anotia, micropinna, small or absent external
auditory canals); eye abnormalities (including microphthalmia); facial
dysmorphia; cleft palate. Documented internal abnormalities include: CNS
abnormalities (including cerebral abnormalities, cerebellar malformation,
hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities;
thymus gland abnormality; parathyroid hormone deficiency. In some cases
death has occurred with certain of the abnormalities previously noted.
Cases of IQ scores less than 85 with or without obvious
CNS abnormalities have also been reported. Accutane is contraindicated
in females of childbearing potential unless the patient meets all of the
following conditions:
· Must NOT be pregnant
or breast feeding.
· Must be capable of complying
with the mandatory contraceptive measures required for Accutane therapy
and understand behaviors associated with an increased risk of pregnancy.
· Must be reliable in understanding
and carrying out instructions.
Accutane must be prescribed under the System to
Manage Accutane Related Teratogenicityä(S.M.A.R.T.ä).
To prescribe Accutane, the prescriber must obtain
a supply of yellow self-adhesive Accutane Qualification Stickers. To obtain
these stickers:
1) Read the booklet entitled System to Manage Accutane
Related Teratogenicity (S.M.A.R.T.) Guide to Best Practices.
2) Sign and return the completed S.M.A.R.T. Letter
of Understanding containing the following Prescriber Checklist:
· I know the risk and severity
of fetal injury/birth defects from Accutane
· I know how to diagnose
and treat the various presentations of acne
· I know the risk factors
for unplanned pregnancy and the effective measures for avoidance of unplanned
pregnancy
· It is the informed patient’s
responsibility to avoid pregnancy during Accutane therapy and for 1 month
after stopping Accutane. To help patients have the knowledge and tools
to do so: Before beginning treatment of female patients with Accutane
I will refer for expert, detailed pregnancy prevention counseling and
prescribing, reimbursed by the manufacturer, OR I have the expertise to
perform this function and elect to do so
· I understand, and will
properly use throughout the Accutane treatment course, the S.M.A.R.T.
procedures for Accutane, including monthly pregnancy avoidance counseling,
pregnancy testing and use of the yellow self-adhesive Accutane Qualification
Stickers
3) To use the yellow self-adhesive Accutane Qualification
Sticker: Accutane should not be prescribed or dispensed to any patient
(male or female) without a yellow self-adhesive Accutane Qualification
Sticker.
For female patients, the yellow self-adhesive Accutane
Qualification Sticker signifies that she:
· Must have had 2 negative
urine or serum pregnancy tests with a sensitivity of at least 25 mIU/mL
before receiving the initial Accutane prescription. The first test (a
screening test) is obtained by the prescriber when the decision is made
to pursue qualification of the patient for Accutane. The second pregnancy
test (a confirmation test) should be done during the first 5 days of the
menstrual period immediately preceding the beginning of Accutane therapy.
For patients with amenorrhea, the second test should be done at least
11 days after the last act of unprotected sexual intercourse (without
using 2 effective forms of contraception). Each month of therapy, the
patient must have a negative result from a urine or serum pregnancy test.
A pregnancy test must be repeated every month prior to the female patient
receiving each prescription.
· Must have selected and
have committed to use 2 forms of effective contraception simultaneously,
at least 1 of which must be a primary form, unless absolute abstinence
is the chosen method, or the patient has undergone a hysterectomy. Patients
must use 2 forms of effective contraception for at least 1 month prior
to initiation of Accutane therapy, during Accutane therapy, and for 1
month after discontinuing Accutane therapy. Counseling about contraception
and behaviors associated with an increased risk of pregnancy must be repeated
on a monthly basis.
Effective forms of contraception include both primary
and secondary forms of contraception. Primary forms of contraception include:
tubal ligation, partner’s vasectomy, intrauterine devices, birth control
pills, and topical/injectable/implantable/insertable hormonal birth control
products. Secondary forms of contraception include diaphragms, latex condoms,
and cervical caps; each must be used with a spermicide.
Any birth control method can fail. Therefore, it
is critically important that women of childbearing potential use 2 effective
forms of contraception simultaneously. A drug interaction that decreases
effectiveness of hormonal contraceptives has not been entirely ruled out
for Accutane. Although hormonal contraceptives are highly effective, there
have been reports of pregnancy from women who have used oral contraceptives,
as well as topical/injectable/implantable/insertable hormonal birth control
products. These reports occurred while these patients were taking Accutane.
These reports are more frequent for women who use only a single method
of contraception. Patients must receive written warnings about the rates
of possible contraception failure (included in patient education kits).
Prescribers are advised to consult the package insert
of any medication administered concomitantly with hormonal contraceptives,
since some medications may decrease the effectiveness of these birth control
products. Patients should be prospectively cautioned not to self-medicate
with the herbal supplement St. John’s Wort because a possible interaction
has been suggested with hormonal contraceptives based on reports of breakthrough
bleeding on oral contraceptives shortly after starting St. John's Wort.
Pregnancies have been reported by users of combined hormonal contraceptives
who also used some form of St. John's Wort (see PRECAUTIONS).
· Must have signed a Patient
Information/Consent form that contains warnings about the risk of potential
birth defects if the fetus is exposed to isotretinoin.
· Must have been informed
of the purpose and importance of participating in the Accutane Survey
and have been given the opportunity to enroll (see PRECAUTIONS).
The yellow self-adhesive Accutane Qualification Sticker
documents that the female patient is qualified, and includes the date
of qualification, patient gender, cut-off date for filling the prescription,
and up to a 30-day supply limit with no refills.
These yellow self-adhesive Accutane Qualification Stickers
should also be used for male patients.
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