isotretinoin and contraception

Last edited 07/2021 and last reviewed 04/2023

Effective contraception is required when a woman of child bearing age is using isotretinoin (1,2)

The British National Formulary addresses the issue of contraception and isotretinoin use (3):

• 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

• 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
  
  
• 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
  • 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

Reference:

• 1. British association of dermatologists 2003.
• 2. British National Formulary. Isotretinoin (Accessed July 11th 2021)