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acused of causing alarm by using emotive language, says Prof Kent Woods

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Prof Kent Woods

Medicines and Healthcare Products Regulatory Agency

http://www.guardian.co.uk/medicine/story/0,11381,1170150,00.html

Patients must know about side-effects

Tuesday March 16, 2004

The Guardian (letters page)

-You gave extensive coverage to Brook's personal opinion on

the rigour of the regulatory review of the antidepressant Seroxat,

even though his views are not shared by this agency's expert

advisors or by any other regulatory body in the world (Drug safety

agency accused of cover-up, March 13).

It is regrettable that this may cause alarm and confusion among

vulnerable patients by presenting his opinion as if it were

suppressed fact. Patients are entitled to clear, consistent advice

based on thorough evaluation of all evidence. The guidance issued by

the Committee on Safety of Medicines (CSM) last Thursday reminded

doctors of the starting dose recommendation which has been in place

since the drug was licensed. Brook's use of emotive language such

as " negligence " and " gagging " does an injustice to the months of

careful review of the evidence on this class of drug which has been

carried out by the CSM's expert working group on safety of SSRIs,

and which has been clearly communicated and explained to doctors and

patients at each stage.

Prof Kent Woods

Medicines and Healthcare Products Regulatory Agency

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