Committee on Safety of Medicines (Hansard, 24 March 2004)

§ Dr. Ladyman

The safety of medicines is continually monitored by the Medicines and Healthcare products Regulatory Agency (MHRA), with expert advice from the Government's independent expert advisory committee, the Committee on Safety of Medicines (CSM).

Early information on the risk of stroke in dementia patients treated with risperidone was assessed by the MHRA in 2002, resulting in changes to the product information to include appropriate warnings. However, it was not until later in 2003, when further data became available, that revealed the magnitude of the risk and potential public health implications. The CSM was consulted in December 2003, as soon as all the data and subsequent analyses had been compiled and assessed by the MHRA. The CSM considered an assessment of all available data from clinical trials with risperidone and advised that additional analyses of the risperidone clinical trials in dementia and analysis of the risk of alternative treatments were required, as well as expert advice in the treatment of patients with dementia.

An expert working group, including geriatricians, psychogeriatricians and psychiatrists, met on 19 January 2004 to consider a formal meta-analysis of clinical trial data for risperidone and clinical trial data on olanzapine, which had recently become available. The CSM considered the recommendations of the expert working group at the end of January and advised that the risks of stroke with risperidone and olanzapine should be communicated accompanied by comprehensive treatment guidelines to inform the necessary changes in prescribing practice. In the case of a third atypical antipsychotic quetiapine, there were insufficient data to draw conclusions.

Risperidone has a United Kingdom marketing authorisation, whereas olanzapine has a European authorisation valid throughout the European Community. The communication in the UK on 9 March 2004 on risperidone and olanzapine was planned to coincide with a Europe-wide communication on olanzapine following consideration by the European scientific committee, the Committee for Proprietary Medicinal Products (CPMP) at its February meeting.

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The CSM, through the MHRA, has close links with regulatory authorities world-wide. The MHRA is represented on the CPMP and its Pharmacovigilance Working Party (PhVWP), which meet monthly and provide a regular forum for discussion of drug safety issues within the European Union. An electronic communication system allows rapid exchange of drug safety information between member states. The PhVWP has regular videoconferences to share drug safety information with the Food and Drug Administration in the United States of America. The MHRA is a member of the Vigimed mailing list, which is an e-mail distribution list set up to facilitate rapid exchange of information between National Centres participating in the World Health Organisation International Drug Monitoring Programme. The MHRA also has informal links with other regulatory authorities world-wide.

There is an obligation on companies making an application for a marketing authorisation to provide the MHRA with all information relevant to the assessment of risks and benefits on the product at the time of the application; this includes data from clinical trials conducted outside the UK. For marketed drugs, the marketing authorisation holder's "qualified person", who is responsible for their pharmacovigilance system, has an obligation to inform the MHRA of any information relevant to the evaluation of the risks and benefits of the product.

Aside from the data and interpretation received from the company, and their corresponding applications to vary the Marketing Authorisation, no representations were received on the risk of stroke with antipsychotics before the announcement of 9 March.