§ Dr. GibsonTo ask the Secretary of State for Health if the new antipsychotic drugs for schizophrenia have been tested for side effects; and what conclusions were made. [3453]
Ms Blears: I apologise to my hon. Friend for the delay in responding to this question. I refer him to the reply that my right hon. Friend the Secretary of State gave my hon. Friend the Member for Blackpool, North and Fleetwood (Mrs. Humble) on 5 March 2000, Official Report, column 192W.
Companies applying for a licence to market a new drug are required to submit the result of clinical trials. These trials will include data on the side effect profile of the products under investigation.
All recently introduced antipsychotics, which include clozapine, risperidone, olanzapine and quetiapine, have been tested in clinical trials on large numbers of patients in order to adequately characterise their side effect profiles.
These drugs are recognised to produce side effects in some patients, most frequently extrapyramidal symptons, dizziness, postural hypotension, and weight gain. More rarely these drugs may produce more serious adverse effects including blood disorders or neuroleptic malignant syndrome, or serious movement disorders (tardive dyskinesia) with prolonged use. These side effects are described in the summary of product characteristics for the individual products.
1020WThe clinical data collected in the trials of these drugs indicate that these new antipsychotics are generally better tolerated by patients than the older drugs in that some side effects occur less frequently or with reduced severity.
In all cases the information on adverse events related to use of the drug (side effect profile) must be considered in relation to the clinical benefit produced by the drug. The potential for harm from possible side effects must be weighed against the likely benefit to patients from the drug. Such a judgment is termed an overall risk to benefit assessment. For all new antipsychotic drugs which have been granted a licence, this overall risk to benefit assessment was considered to be positive.