3: Recommendations for prescribing of oral retinoids for women of
reproductive age
Patient selection
Prescribe for:
- Patients with severe, intractable cystic acne or
keratinisation disorders, unresponsive to other therapies.
- Reliable patients who have a responsible attitude to
contraception. Contraception should also be used by women who think
they are infertile. 7
Unwise to prescribe for:
- Patients who refuse contraception or who have a poor understanding
of its use, or for whom contraception has failed in the past.
- Patients with a serious retinal disorder 3 or mental depression (or those
taking antidepressants).
- Special precautions and monitoring are needed for patients with a
history of hepatitis, diabetes, hyperlipid aemia and
atherosclerosis or pancreatitis (many of which are
contraindications if the combined oral contra ceptive pill is used).
- Patients with contact lenses should be particularly careful with
lens hygiene and perhaps use artificial tears.
Patient education and informed consent
- All patients should be warned about side effects and teratogenicity
and provided with written information.
- Detailed contraceptive counselling should be provided, including
circumstances under which oral contraceptives may fail (e.g., late
or missed pills, drug interactions and gastro intestinal upsets),
and use of secondary precautions. 17
- Signed consent is necessary to reinforce these messages. Patients
should also undertake to stop medication immediately once a
menstrual period is delayed, and to immediately advise their general
practitioner and dermatologist.
Monitoring and management
Tests
- A serum pregnancy test should be undertaken within two weeks
before commencing treatment.
- Other tests before prescription include: a complete blood cell
count (with a differential count), a total lipid screen, liver
function tests, creatin ine level and urinalysis. These tests should
be repeated at least one month later while the patient is taking the
drug. If the results are normal, tests probably need not be repeated
unless dose is increased or there is a clinical indication.
- If long term treatment is planned (e.g., with etretinate or
acitretin), radiographic examinations (lateral chest and foot)
should be undertaken every 12 months. Abnormal results
(hyperostosis) may require reduction of dosage or treatment
discontinuation.
Drug therapy and dosage
- In keratinisation disorders, the highest tolerable dose of
etretinate/acitretin should be aimed for. For isotretinoin, a
therapeutically effective and well tolerated dose should be given,
keeping in mind that it is the total cumulative dose which is
important.
- Therapy should be commenced on the second or third day of the next
normal menstrual period, and drugs provided only for two months at a
time.
Drug interactions
- Concomitant treatment with tetracyclines is theoretically
contraindicated, as tetracyclines also have the potential to induce
intracranial hypertension.
- Methotrexate should be avoided because of its hepato toxic
potential. Insulin therapy may need adjustment in diabetic
patients, as etretinate and acitretin improve glucose tolerance.
3
- Alcohol should be avoided with acitretin as its use is associated
with conversion of acitretin to etretinate. 3,13
Type of contraception
- An oestrogen-progestogen combined pill (preferably low-dose) is
the method of choice, 18 but
contraindications to its use must be noted. It is advisable to use
another method of contraception concomitantly 16 (e.g., condoms or a diaphragm) to
minimise pregnancy risk.
- In the presence of masculinisation features, a
cyproterone-acetate-based contraceptive (Diane-35ED, Schering)
during and especially after retinoid treatment may be helpful.
18
- The minipill (low-dose progestogen) is not recommended as a
contraceptive in oral retinoid therapy, as it acts predominantly by
modifying cervical mucus; 18
its efficacy may be reduced by the action of oral retinoids o
epithelial (including mucosal layer) differentiation. 9 It also has a higher failure rate tha
the combined pill.
- For patients who have difficulty taking oral contraceptives
regularly, an injectable contraceptive, medroxyprogesterone
acetate (Depo-Provera C150, Upjohn), is recommended. 6
- Older patients who use intrauterine contraceptive devices and
refuse to take oral contraceptives may use the intrauterine
contraceptive device in conjunction with a second method of
contraception such as condoms. 18
- Dermatologists should check monthly, as far as possible, that
adequate contraception is being maintained and there is no
indication of pregnancy.
Communication
- Good communication between the prescribing dermatologist and the
patient's general practitioner (and other clinicians) is
essential, particularly when someone other than the dermatologist
is prescribing contraception, or when pregnancy occurs
inadvertently.
- Counselling when pregnancy occurs is based on the estimated risk of
teratogenicity. For pregnancies conceived in the contraceptive
period after therapy, the risk appears to be relatively low. 8,9 An undetectable plasma retinoid
level ( < 2 ng/mL) suggests safety, but in the case of etretinate and
acitretin cannot predict their absence in adipose tissue. 19
- Notification of pregnancy exposure (without identifiers) and its
subsequent outcome to the manufacturer will assist in clarifying
teratogenic risks and the extent of exposure.
- The manufacturer currently promotes drug information through
regular visits to dermatologists and seminars with general
practitioners.
To article.
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