Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0600
Facsimile 0171- 273 0737	.
	20 November 1998

Dear Charles,

RITALIN AND NEUROLEPTIC WITHDRAWAL

Thank you for your further letter of 20 October 1998.

I am sorry my earlier reply was apparently lost in the post. I was replying to you with the views of the MCA. I note that Professor Rawlins has since replied and agree with his comments in respect of the SPC for Ritalin.

On your concern about the increasing use of Ritalin, I understand from colleagues at the Department that paediatricians, psychologists and child psychiatrists are recognising those who fulfil the criteria for a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) more frequently than before. In addition, other children with awkward behaviour have this diagnosis raised by teachers, parents and GPs though they may not fulfil the criteria as such. There are a number of reviews covering the use of Ritalin and the role of other interventions in ADHD and these may be factors which help explain the increase both in children diagnosed as having ADHD and in the number of prescriptions for Ritalin. I understand that FOCUS, a clinical effectiveness organisation based at the Royal College of Psychiatrists' Research Unit is currently preparing guidance on prescribing practice for ADHD and that this will address the use of Ritalin together with other drug treatments.

You appear to doubt the independence of the CSM and its relationship with the MCA. The CSM provides expert advice to Ministers acting as the Licensing Authority whose executive arm is the MCA. (The CSM, of course, has a further role in encouraging ADR reporting). When I used the tern "we" in my earlier letter, I was speaking for the MCA though on this matter it is also my view that neither the MCA nor the CSM have direct responsibility for prescribing decisions. Both play important parts in ensuring helpful information is available to health professionals and the public through product and patient information, and, on occasion, when it is necessary to remove an unsafe product from the market.

I understand that the article you sent with your letter to Professor Rawlins will now be published next month. As I previously said, we are looking at the question of neuroleptic withdrawals and will comment further, if necessary, in the light of the published report.

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