Brand Name(s):Roaccutane




Review Date:Jul-24

Drug Safety Update
Oral retinoid medicines: revised and simplified pregnancy prevention educational materials for healthcare professionals and women
June 2019

Drug Safety Update
Isotretinoin (Roaccutane): rare reports of erectile dysfunction and decreased libido
Drug Safety Update- Isotretinoin (Roaccutane): reminder of possible risk of psychiatric disorders-warn patients and family; monitor patients for signs of depression. Full update available at:
December 2014
All women should be made aware of the teratogenic risks before starting treatment
Pregnancy must be excluded before treatment with oral retinoids
Pregnancy test results (with a minimum sensitivity of 25 mIU/mL) must be documented 3 days or less before the prescription is issued
Women of childbearing potential should be on at least one, or preferably two, complementary forms of effective contraception (eg, barrier and hormonal)
Contraception should start 1 month before treatment, and should continue throughout oral retinoid treatment and after until the retinoids have left the patient’s system-ie:
At least 1 month after stopping treatment with isotretinoin or alitretinoin
At least 2 years after stopping treatment with acitretin
Females should undergo a pregnancy assessment every 4 weeks at follow-up appointments
Specialist advice from a physician specialised in teratology must be sought immediately if a pregnancy occurs
Prescription of oral retinoids should be limited to 30 days’ treatment
The prescription must be dispensed within 7 days of issue
Available data suggest that maternal exposure from the semen of patients receiving an oral retinoid is not associated with teratogenic effects
further information at:
Drug Safety Update June 2013
Serious skin reactions (EM, SJS, and TEN) have been reported in association
with isotretinoin, which may result in hospitalisation, disability, life-threatening
events, or death

*Isotretinoin must be immediately discontinued and appropriate supportive care
given if symptoms of EM, SJS, or TEN develop

*Patients starting isotretinoin treatment should be informed of the signs and
symptoms of these serious skin eruptions and advised to stop treatment and
contact their healthcare professional immediately if any of these arise

MHRA Drug Safety Update Volume 4 Issue 2 September 2010

The British Association of Dermatologists has issued advice on the safe use of isotretinoin in the UK, focusing on the risks of teratogenicity and mood changes. It notes that all women of childbearing potential must use reliable contraception and undergo monthly pregnancy testing. Although data regarding mood changes are conflicting, patients and their families should be made aware of possible adverse effects.

Isotretinoin should only be prescribed by, or under the supervision of, consultant dermatologists. It may not otherwise be prescribed by GPs or GPs with a Special Interest (GPwSI).

Advice on the safe introduction and continued use of isotretinoin in acne in the U.K – .British Journal of dermatology March 2010