Oral retinoid medicines (isotretinoin▼, alitretinoin▼, and acitretin▼): temporary monitoring advice during coronavirus (COVID-19) pandemic
We have published guidance about the use of remote consultations for pregnancy prevention in women of childbearing potential and monitoring for signs of psychiatric reactions (especially depression) and other safety risks in all patients taking oral retinoid medicines during the COVID-19 pandemic.
Post-publication note: October 2023
The advice in this article and the guidance to healthcare professionals was published during the COVID-19 pandemic. These temporary regulatory recommendations are no longer in force and have been withdrawn. Clinical guidance should be referred to for advice on consultations for patients on isotretinoin.
We ask healthcare professionals to consult the October 2023 Drug Safety Update and Report of the Isotretinoin Implementation Advisory Expert Working Group when referring patients and when prescribing or dispensing isotretinoin.
Guidance for specialists
Oral forms of the retinoid medicines isotretinoin, alitretinoin and acitretin are used in the treatment of severe dermatological diseases that are resistant or unresponsive to standard therapies.
We have recently issued Guidance for specialists to support the safety of patients on oral retinoids.
The requirements for monitoring of these safety issues reflect established safety measures for oral retinoid medicines. Prescribing of these medicines is understood to be increasing to more normal levels following reduced use earlier in the pandemic.
The Guidance is to remind specialists of the need to implement the Pregnancy Prevention Programme (PPP) and monitor all patients taking oral retinoids and to support them in protecting the safety of patients while remote appointments continue. The guidance also includes advice that can be provided to patients to help them understand the monitoring requirements.
Psychiatric adverse events have been reported in patients taking oral retinoids for skin disorders, and with respect to isotretinoin; these are currently under review. Prescribers are reminded to inform patients of the risk of psychiatric side effects. Patients should also be encouraged to inform friends and family that they are taking an oral retinoid so that they can be alert for any changes in mood.
Remote consultations should occur with at least the same frequency as the usual clinic consultations, to allow adequate monitoring of mental health and other potential adverse events.
We will publish updated information once these temporary recommendations are no longer considered necessary. These requirements are not applicable to topically applied retinoids and the product information should be consulted for recommendations about these products.
Report suspected reactions on a Yellow Card
Isotretinoin, alitretinoin and acitretin are black triangle medicines and all suspected adverse reactions should be reported via the Yellow Card scheme.
Reports can be made of suspected reactions experienced at any time, including historic adverse experiences with medicines. Please include in the report as much detail as possible, particularly if a side effect continued or started after treatment was stopped.
Report to the Yellow Card scheme electronically using:
- the Yellow Card website
- the Yellow Card app; download from the Apple App Store or Google Play Store
- some clinical IT systems for healthcare professionals (EMIS, SystmOne, Vision, MiDatabank, and Ulysses)
When reporting please provide as much information as possible, including information about batch numbers, medical history, any concomitant medication, onset timing, treatment dates, and product brand name.
Report suspected side effects to medicines, vaccines or medical device and diagnostic adverse incidents used in coronavirus (COVID-19) using the dedicated Coronavirus Yellow Card reporting site or the Yellow Card app. See the MHRA website for the latest information on medicines and vaccines for COVID-19.
Article citation: Drug Safety Update volume 14, issue 12: July 2021: 3.