Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of potential impact of second-generation antipsychotic drugs on levels of risk of venous thromboembolism.

Antipsychotic medicines are used to treat a range of mental health disorders, mainly schizophrenia and bipolar disorder, sometimes called manic depression, but may also be used in severe or difficult to treat anxiety or depression. Antipsychotics are generally classified as either first-generation, conventional or typical, or second-generation, atypical medicines. Second-generation, atypical, antipsychotics act on a broader range of neurotransmitter receptors than first-generation antipsychotics.

In 2009 the Medicines and Healthcare products Regulatory Agency (MHRA) conducted a Europe-wide review of data on the risk of venous thromboembolism (VTE) associated with the use of antipsychotic medicines.

Second‑generation, atypical, antipsychotics licensed in the United Kingdom at the time of the MHRA review included amisulpride, aripiprazole, clozapine, olanzapine, quetiapine, risperidone, sertindole, and zotepine. Since then, additional newer atypical antipsychotics have been authorised in the UK, including medicines such as lurasidone, paliperidone, and cariprazine.

Following the review, the MHRA updated prescribing information and published advice for healthcare professionals indicating that:

• antipsychotics use may be associated with an increased risk of VTE;

• at that time there was insufficient data available to determine any difference in risk between atypical and conventional antipsychotics, or between individual drugs; and

• all possible risk factors for VTE should be identified before and during antipsychotic treatment and preventive measures undertaken.

As a result of this review and subsequent regulatory action, UK product information of second-generation antipsychotics, including those licenced after the review, contains warnings regarding the potential risk of VTE. The safety of these medicines continue to be monitored by the MHRA.