(2) what research his Department has (a) commissioned and (b) reviewed on the potential risks to health and other side effects of chlorpromazine hydrochloride prescribed for the treatment of people diagnosed with autism in the last 10 years; and if he will make a statement;
(3) how many fatalities of people diagnosed with autism associated with the use of chlorpromazine hydrochloride and other anti-psychotic medication there were in the last 10 years.;
(4) what guidelines his Department has issued on medication prescribed for the treatment of people diagnosed with autism; and what guidelines are in force on the use of anti-psychotic medication for people with autistic spectrum disorders.
Since the marketing of chlorpromazine, the Medicines and Healthcare products Regulatory Agency (MHRA) in conjunction with its independent scientific advisory committee, the Commission on Human Medicines (CHM) and its predecessors, has kept the safety of chlorpromazine and other anti-psychotics under close review. Prescribing guidance has been updated to reflect new safety data and the MHRA has also informed health care professionals and patients of the updated prescribing guidance through the regular drug safety bulletin, “Drug Safety Update”, and information posted on the MHRA website.
Reports of suspected adverse drug reactions (ADRs) are collected by the MHRA and CHM through the Yellow Card Scheme. During the time period 1 January 2000 to 31 December 2009, the MHRA has received a total of 18 spontaneous suspected fatal ADR reports associated with chlorpromazine in the United Kingdom. None of these cases describe an indication for use of autism or have provided a medical history of the patient having autism. During this 10 year period a total of 39 fatal reports for all anti-psychotics listed the indication as ‘learning disorder/disability’ or ‘behavioural disorder’ or had a medical history of autism, asperger’s disorder, learning disability or behavioural disorder.
The use of medication such as anti-psychotic drugs for behaviour problems is an issue that will most likely be addressed in the clinical guidelines for autistic spectrum disorders in adults and children currently being developed by the National Institute for Health and Clinical Excellence (NICE). NICE has not yet indicated when it expects this guidance to be issued to be available to the national health service.