Posted: Saturday 13 March 2004
Richard Brook said:
"On Thursday the Agency at last published information advising that many thousands of men and women in this country may have been taking Seroxat at a dose that was unsafe. What they failed to mention - and what I am now making public - is the fact that the regulator had the data on which the basis of this decision was made for well over a decade as part of the original license application.
"Either they didn't understand the full implications of the available medical data at the time or, worse, that data was fully understood and they failed to act. Either way it amounts to extreme negligence and a clear dereliction of the MHRA's duty to safeguard the well-being of the British public.
"Drugs regulation simply has to put patients' interests first. We will continue to press the MHRA to release any information that is in the direct interests of consumers promptly and fully and we are restating our previous calls for a full and independent review of UK drugs regulation."
Reiterating advice issued by the Department of Health on Thursday (11 March), Richard Brook said:
"We would like to stress that anyone with concerns about their medication should contact a doctor before taking any further course of action. On no account should anyone simply stop taking an antidepressant such as Seroxat without medical advice."
*** Ends ***
(*1) Seroxat is one of a group of newer antidepressants called SSRIs (Selective Serotonin Reuptake Inhibitors)