MHRA-LOGO.gif (6825 bytes) Medicines and Healthcare products
Regulatory Agency

Market Towers
1 Nine Elms Lane, London SW8 5NQ


Mr Charles Medawar
Social Audit Ltd
P.O. Box 111
London NW1 8XG

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E-mail [email protected]

Direct line:  020 7084 2664
Direct fax:  020 7084 2293

Email:   [email protected]

                                              25 July 2006


Dear Mr Medawar,

RE: EFEXOR XL (venlafaxine): PL 00011/0223-0224 & 00011/0199-0201 Advertisement in BMJ of 16 April 2005

Thank you for your letter of the 30 June 2006 seeking clarification on why the corrective statement was published in the GP version of the BMJ, when you complained about the Efexor advertisement that appeared in the clinical research version.

A corrective statement is used to correct any misconceptions which may have led to inappropriate prescribing or use of the product and potential risk to public health. The Urgent Safety Restriction (USR) imposed on Efexor led to the restriction of prescribing to specialist mental health practitioners, including GPs with a special interest, which would affect GPs prescribing practice more than specialist healthcare professionals. It was this concern about primary care physicians not being made aware of the change relating to initiation of treatment that you raised in your original complaint. It was agreed between the MHRA and Wyeth, therefore, that the corrective statement would be published in the GP version of the BMJ to ensure that those most affected by the USR, GPs, would be aware of changes to Efexor licence and the actions taken in relation to the Efexor advertisement.

To conclude, I can confirm that both the size and the location of the correction were agreed between the MHRA and Wyeth prior to publication. It was the public health implication of the misconceptions caused by the advertisement that prompted the switch to a journal version that would inform those most at risk of inappropriately prescribing Efexor of possible misconceptions and our actions.

I hope this provides the reassurance you were seeking, should you need any further information please do not hesitate to contact us again.

Thank you for your continued interest in this matter.

Yours sincerely,

Dr Nageen Hashmi

Assessor, Advertising Standards Unit
Vigilance and Risk Management of Medicines