The Medicines and Healthcare products Regulatory Agency has
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.
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:
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.
