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<p>As with all medicines in the United Kingdom, the Medicines and Healthcare products
Regulatory Agency continuously monitors the safety of isotretinoin-containing medicines.
This includes reports of suspected adverse drug reactions submitted by healthcare
professionals, patients and carers through the Yellow Card scheme, as well as published
and unpublished data. As new evidence on safety emerges it is carefully evaluated
and, where appropriate, product information is updated and advice for prescribers
and patients is issued.</p><p>Specific assessments of possible psychiatric side effects
associated with isotretinoin were considered by an Expert Working Group of the Commission
on Human Medicines in 2005 and 2014. In addition, the risk of neuropsychiatric disorders
was evaluated in a European review which was completed in 2018. This review concluded
that the warnings in the product information for medicines containing isotretinoin
regarding possible psychiatric adverse effects reflected what was known.</p><p>Since
1998, warnings regarding the possible risk of developing depression and other psychiatric
side effects have been included in the product information for Roaccutane and the
generic versions of isotretinoin (the Summary of Product Characteristics for healthcare
professionals and the patient information leaflet). The product information for isotretinoin
warns that treatment may be associated with possible psychiatric side effects, that
particular care needs to be taken in patients with a history of depression; and that
all patients on isotretinoin should be monitored for signs of depression and referred
for appropriate treatment if necessary. It also states that stopping isotretinoin
may not lead to improvement and therefore further psychiatric or psychological evaluation
may be necessary.</p>
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