Clozapine: Side Effects
The question
To ask the Secretary of State for Health and Social Care, whether the Yellow Card adverse drug reaction reference GB-MHRA-MED-202605220730230940-NSQYR (linked to case file CEC 256289) is being actively reviewed by the clinical assessors of the Neurology, Pain and Psychiatry Expert Advisory Group as part of their current, ongoing safety review into clozapine drug-level monitoring for toxicity.
Answered by Preet Kaur Gill
The Medicines and Healthcare products Regulatory Agency (MHRA) confirms that in June 2026, the Neurology, Pain and Psychiatry Expert Advisory Group (NPPEAG) considered an assessment of clozapine drug level monitoring. The NPPEAG provided advice about the requirements for this type of monitoring. At present, clozapine drug-level monitoring is required only in specific clinical situations, partly because of the high level of variability between patients. The MHRA is taking forward the NPPEAG’s recommendations and will communicate to healthcare professionals once the regulatory position is finalised.
The review of clozapine drug-level monitoring focused on clinical and scientific data to establish the value of this type of monitoring in clinical practice. It took into account a range of information, including overall reporting patterns and themes in reports received through the Yellow Card scheme, but did not include clinical review of individual Yellow Card reports. MHRA safety assessments may also consider the views of patients and other stakeholders.
The MHRA will be launching a survey in the summer to gather information on awareness of key risks associated with clozapine, and to assess whether additional measures would be helpful for patients, their families, and carers, as well as healthcare professionals involved in the care of patients receiving clozapine.
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