MHRA/CHM ADVICE: ISOTRETINOIN (ROACCUTANE ®): RARE
REPORTS OF ERECTILE DYSFUNCTION AND DECREASED LIBIDO
(OCTOBER 2017)
An EU-wide review has concluded that on rare occasions,
oral isotretinoin, indicated for severe acne, may cause
sexual side-effects, including erectile dysfunction and
decreased libido.
MHRA/CHM ADVICE: ORAL RETINOID MEDICINES: REVISED AND
SIMPLIFIED PREGNANCY PREVENTION EDUCATIONAL MATERIALS
FOR HEALTHCARE PROFESSIONALS AND WOMEN (JUNE 2019)
New prescriber checklists, patient reminder cards, and
pharmacy checklists are available to support the
Pregnancy Prevention Programme in women and girls of
childbearing potential taking oral acitretin, alitretinoin,
or isotretinoin. Healthcare professionals are reminded
that the use of oral retinoids is contra-indicated in
pregnancy due to a high risk of serious congenital
malformations, and any use in females must be within
the conditions of the Pregnancy Prevention Programme
(see Conception and contraception and Prescribing and
dispensing information).
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.
PDF page 1359
→Appendix 1: retinoids
PDF page 1360
▶Common or very common Alopecia. anaemia. arthralgia.
back pain. cheilitis. dry eye. eye discomfort. eye
inflammation. haemorrhage. headache. increased risk of
infection. myalgia. nasal dryness. neutropenia.
proteinuria. skin fragility (trauma may cause blistering).
skin reactions. thrombocytopenia. thrombocytosis
▶Rare or very rare Anxiety. arthritis. behaviour abnormal.
bone disorders. bronchospasm. cataract. corneal opacity.
depression. diabetes mellitus. dizziness. drowsiness. dry
throat. gastrointestinal disorders. glomerulonephritis.
hair changes. hearing impairment. hepatitis. hoarseness.
Skin
hyperhidrosis. hyperuricaemia. idiopathic intracranial
hypertension. inflammatory bowel disease.
lymphadenopathy. malaise. mood altered. nail dystrophy
. nausea. pancreatitis. photosensitivity reaction.
psychotic disorder. pyogenic granuloma. seizure. suicidal
tendencies. tendinitis. vasculitis. vision disorders
▶Frequency not known Rhabdomyolysis. severe cutaneous
adverse reactions (SCARs)
SIDE-EFFECTS, FURTHER INFORMATION Risk of pancreatitis
if triglycerides above 9 mmol/litre—discontinue if
uncontrolled hypertriglyceridaemia or pancreatitis.
Discontinue treatment if skin peeling severe or
haemorrhagic diarrhoea develops.
Visual disturbances require expert referral and possible
withdrawal.
Psychiatric side-effects could require expert referral.
PDF page 1360
The MHRA advises
that women and girls of childbearing potential being
treated with the oral retinoids acitretin, alitretinoin, or
isotretinoin must be supported on a Pregnancy Prevention
Programme with regular follow-up and pregnancy testing.
Pregnancy prevention Effective contraception must be used.
In females of childbearing potential, exclude pregnancy
a few days before treatment, every month during
treatment (unless there are compelling reasons to indicate
that there is no risk of pregnancy), and 4 weeks after
stopping treatment. Females must practise effective
contraception for at least 1 month before starting
treatment, during treatment, and for at least 1 month after
stopping treatment. They should be advised to use at least
1 method of contraception, but ideally they should use 2
methods of contraception. Oral progestogen-only
contraceptives are not considered effective. Barrier
methods should not be used alone, but can be used in
conjunction with other contraceptive methods. Females
should be advised to discontinue treatment and to seek
prompt medical attention if they become pregnant during
treatment or within 1 month of stopping treatment.
PDF page 1360
Manufacturer advises avoid—teratogenic.
PDF page 1360
Avoid.
PDF page 1360
Manufacturer advises avoid—
limited information available.
PDF page 1360
Dose adjustments In severe impairment, reduce initial dose
(e.g. 10 mg daily) and increase gradually up to 1 mg/kg
daily as tolerated.
PDF page 1360
Measure hepatic function
and serum lipids before treatment, 1 month after starting
and then every 3 months (reduce dose or discontinue if
transaminase or serum lipids persistently raised).
PDF page 1360
