---

Isotretinoin: Side Effects

Answer

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submitted by healthcare professionals, patients and carers through the Yellow Card scheme, as well as published and unpublished data.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.

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.

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.

Secondary information

Type

Written question

Reference

255661

Session

2017-19

Subjects

Side effects Isotretinoin

Link

View this Written question on www.parliament.uk