Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he plans to review national protocols that require the automatic cessation of Clozapine following a single red blood result, in the context of cases where such results have subsequently been found to be spurious.

Clozapine is used to treat people with schizophrenia in whom other medicines have not worked and it is also used to treat severe disturbances in the thoughts, emotions, and behaviour of people with Parkinson’s disease in whom other medicines have not worked.

Clozapine is associated with potentially life threatening side effects including the risk of agranulocytosis. Patients must have regular blood tests to ensure their white blood cell count doesn’t drop too low which is classified as a red result. Clozapine may only be taken if the patient has a normal blood count.

As with all medicines, the safety of clozapine is kept under continual review by the Medicines and Healthcare products Regulatory Agency (MHRA) using a number of data sources including reports of suspected side effects through the Yellow Card Scheme, data from marketing authorisation holders, and research published in the scientific literature.

The MHRA is currently reviewing the blood monitoring requirements associated with clozapine, to ensure these continue to minimise the risk of agranulocytosis whilst allowing patients to access clozapine when needed. Currently, the product information for clozapine, including the summary of product characteristics states that patients must stop clozapine if a red result is obtained and that they should not be re-exposed to clozapine.