§ Paul FlynnTo ask the Secretary of State for Health (1) how many people in the UK have been prescribed roaccutane in each of the past five years; and what proportion of those people have reported symptoms of depression or psychiatric disorders; [91831]
(2) what assessment he has made of the European Committee for Proprietary Medicinal Products' review of safety information for roaccutane. [91832]
§ Ms BlearsIt is not possible to estimate the precise number of patients who have received Roaccutane (isotretinoin) in the United Kingdom in the last five years. However, it has been estimated that approximately 375,000 treatment courses of isotretinoin have been prescribed between 1983 and May 2002.
The table provides the total number of suspected psychiatric disorders reported during each of the past five years through the Yellow Card Scheme for Roaccutane. It also shows the number of reports of symptoms of depression, which forms part of the total psychiatric disorders.
1998 1999 2000 2001 2002 Psychiatric disorders 48 44 50 26 25 Depression 23 17 17 11 11 A report of a suspected adverse reaction does not necessarily mean that it was caused by the medicine. The number of reports received should not be used as a basis for determining the incidence of a reaction as neither the total number of reactions occurring, nor the number of patients using the drug is known.
With expert advice from the Committee on Safety of Medicines, the Medicines Control Agency is currently leading a European-wide review of the product 688W information of isotretinoin products, including Roaccutane, with the aim to ensure that up to date and consistent information is provided to health professionals and patients to optimise its safe use. This review is likely to take some months to complete. Any new advice will be communicated to health professionals and patients.