Isotretinoin (Roaccutane): reminder of possible risk of psychiatric disorders
- Medicines and Healthcare products Regulatory Agency
- 19 December 2014
- Therapeutic area:
- Dermatology and Psychiatry
Warn patients and family, monitor patients for signs of depression
Isotretinoin (Roaccutane, Rizuderm) is licensed for the treatment of severe acne resistant to systemic antibacterials and topical therapy.
There have been reports of psychiatric disorders in patients taking isotretinoin (eg, depression, anxiety, and very rarely suicidal ideation and suicide). Ongoing concerns prompted us to review the available data.
We reviewed all available evidence from published literature and individual case reports (see public assessment report below). Due to conflicting study results and the limitations in the data it was not possible to identify a clear increase in risk of psychiatric disorders in people who take isotretinoin compared to those that do not. In addition there was no clear biological mechanism by which isotretinoin would cause psychiatric disorders. Acne itself is associated with some psychiatric disorders. Also, the age at which many patients take isotretinoin is also the age at which some psychiatric disorders are commonly diagnosed.
Although the review was inconclusive, we considered the evidence sufficient to support the current warnings in the summary of product characteristics. The patient information leaflet already advises patients to discuss any history of mental illness with their doctor before taking isotretinoin. It also tells patients to contact their doctor straight away if they experience any of the psychiatric disorders listed. We are updating the leaflet to advise patients to ask family and friends to help watch out for symptoms of psychiatric disorders.
Advice for healthcare professionals
- Isotretinoin should only be prescribed by or under the supervision of a consultant dermatologist with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements
- warn patients and their family that isotretinoin might cause psychiatric disorders such as depression, anxiety, and in rare cases suicidal thoughts - tell them to watch out for symptoms
- when prescribing isotretinoin to patients with a history of depression, carefully consider the balance of benefits of treatment against the possible risk of psychiatric disorders
- monitor all patients for signs of depression and refer for appropriate treatment if necessary; stopping isotretinoin may not be enough to alleviate symptoms and further psychiatric or psychological evaluation may be necessary.
Article citation: Drug Safety Update volume 8 issue 5, December 2014: A2
Published: 19 December 2014