In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) runs the Yellow Card Scheme. This scheme allows health professionals and patients to report suspected adverse drug reactions, which include suicides, on a voluntary basis. Over the last five years a total of 15 suspected adverse drug reactions of suicide have been reported in association with isotretinoin (Roaccutane) through this scheme. It is important to note that a report of an adverse drug reaction does not necessarily mean that it was caused by the drug. Other factors such as an underlying illness or other medicines may have contributed. Severe acne itself is known to be associated with an increased risk of depressive illness.
The safety of isotretinoin has been closely monitored by the MHRA since it was approved in 1983. The benefits of isotretinoin in the treatment of acne are considered to outweigh the risk of adverse effects by regulatory authorities throughout Europe and worldwide.
Warnings about the risk of depression and suicidal behaviour were added to the product information for prescribers and patients in 1998. These warnings have been strengthened following a European review of the isotretinoin product information and most recently the ‘Roaccutane Patient Information Leaflet’ has been subject to user testing to ensure that the information, including that about risk of suicidal thoughts and behaviour, is clear, comprehensive and understandable.