MHRA/CHM ADVICE: ORAL RETINOID MEDICINES: REVISED AND
SIMPLIFIED PREGNANCY PREVENTION EDUCATIONAL MATERIALS
FOR HEALTHCARE PROFESSIONALS AND WOMEN (JUNE 2019)
Materials to support the Pregnancy Prevention
Programme in women and girls of childbearing potential
taking oral acitretin, alitretinoin, or isotretinoin have
been updated. Oral tretinoin and bexarotene do not have
a Pregnancy Prevention Programme in light of their
oncology indication and specialist care setting. However,
healthcare professionals are advised that these
medicines are extremely teratogenic and product
information should be consulted for contraceptive and
pregnancy testing requirements when used in females of
childbearing potential.
Neuropsychiatric reactions have been reported in
patients taking oral retinoids. Healthcare professionals
are advised to monitor patients for signs of depression or
suicidal ideation and refer for appropriate treatment, if
necessary; particular care is needed in those with a
history of depression. Patients should be advised to
speak to their doctor if they experience any changes in
mood or behaviour, and encouraged to ask family and
friends to look out for any change in mood.
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→Appendix 1: retinoids
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▶Common or very common Abdominal pain. alopecia.
anxiety. appetite decreased. arrhythmia. asthma. bone
pain. cheilitis. chest pain. chills. confusion. constipation
. depression. diarrhoea. dizziness. dry mouth. flushing.
headache. hearing impairment. hyperhidrosis. insomnia.
intracranial pressure increased. malaise. nasal dryness.
nausea. pancreatitis. paraesthesia. respiratory disorders.
skin reactions. visual impairment. vomiting
▶Frequency not known Embolism and thrombosis. erythema
nodosum. genital ulceration. hepatotoxicity.
hypercalcaemia. increased leucocytes. myocardial
infarction. myositis. necrotising fasciitis. QT interval
prolongation. stroke. thrombocytosis. vasculitis
SIDE-EFFECTS, FURTHER INFORMATION Retinoic acid
syndrome Fever, dyspnoea, acute respiratory distress,
pulmonary infiltrates, pleural effusion, hyperleucocytosis,
hypotension, oedema, weight gain, hepatic, renal and
multi-organ failure requires immediate treatment—
consult product literature.
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Effective
contraception must be used for at least 1 month before
oral treatment, during treatment and for at least 1 month
after stopping (oral progestogen-only contraceptives not
considered effective).
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Teratogenic. See Pregnancy and reproductive
function in Cytotoxic drugs p. 938.
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Avoid (discontinue breast-feeding).
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Manufacturer advises caution.
Dose adjustments Manufacturer advises dose reduction to
25 mg/m2.
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Dose adjustments Reduce dose to 25 mg/m2.
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Monitor haematological and
coagulation profile, liver function, serum calcium and
plasma lipids before and during treatment.
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