Roaccutane (active substance, isotretinoin) is authorised for treating severe forms of acne which have been resistant to other standard therapies. It should only be prescribed by or under the supervision of doctors with expertise in using the product and with a full understanding of the risks of therapy and the monitoring requirements.
Under European and Irish legislation, all medicinal products must be authorised before being marketed. Medicinal products marketed in Ireland must be authorised by the Irish Medicines Board (IMB). A determination on an application for authorisation of a medicine is based on a rigorous scientific assessment of the application against legal and regulatory requirements.
Roaccutane has been closely monitored at national and EU level since it was first authorised. It was most recently reviewed at EU level in April 2011 when further warnings regarding skin reactions were added to the product information for patients and their doctors. The risk of depression associated with use of isotretinoin was also reviewed at that time. However, the existing comprehensive information on the risk of depression associated with isotretinoin and the monitoring requirements provided on the product information were considered sufficient.
The inclusion of these, and other side effects and warnings, in the product information are on the basis of information on use of the product including reports of side effects from patients.
The information for patients and for their doctors includes detailed advice on the risks associated with use of Roaccutane and recommendations to minimise their occurrence. The package leaflet advises patients to tell their doctor if they have ever had any mental illness (including depression, suicidal behaviour or psychosis), or if they take medicines for any of these conditions. It also advises them to contact their doctor straight away if they have signs of any of these problems.
The information for doctors lists potential psychiatric disorders. It emphasises that particular care needs to be taken in relation to patients with a history of depression and that all patients should be monitored for signs of depression during their treatment with the product and referred for appropriate treatment if necessary.
The benefits of treatment are considered to outweigh the risks, when the product is used in accordance with the product information.