Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential implications for his policies the (a) side effects and (b) long-term health implications of the use of clozapine as a medicament.

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines and medicinal products and ensures that the product information for each medicines reflects what is known about the medicine and provides information to support safe use and minimise risks. The product information consists of the Summary of Product Characteristics for healthcare professionals and the patient information leaflet supplied in each pack of medicine.

Clozapine was first authorised in 1989 and is now indicated for treatment-resistant schizophrenic patients and in schizophrenia patients who have severe, untreatable neurological adverse reactions to other antipsychotic agents, including atypical antipsychotics. Treatment resistance is defined as a lack of satisfactory clinical improvement despite the use of adequate doses of at least two different antipsychotic agents, including an atypical antipsychotic agent, prescribed for adequate duration.

Clozapine is also authorised to treat psychotic disorders occurring in patients with Parkinson's disease, in cases where standard treatment has failed. Clozapine is associated with several potentially serious side effects which are outlined in the product information, that require monitoring of various aspects of patient’s health to minimise risks including monitoring: white blood cells, blood pressure, heart function, liver function, body weight, glucose, cholesterol, other medication, falls and for signs of infection.

As clozapine is used when other treatments have failed to manage a patient’s condition, careful monitoring is required to minimise the risks to ensure patients are able to receive effective treatment with clozapine.

The safety of clozapine is continuously monitored by the MHRA to ensure the product information reflects what is known about the medicine. The MHRA is in the process of reviewing the blood monitoring requirements and will be seeking views in the summer from patients, patients’ families and healthcare professionals on methods to improve awareness of the risks associated with clozapine and how to manage them.