typical disingenuous reply from MHRA to mr Bryce

[Guest guest]

CONFIDENTIAL Mr Bryce ********* ***** *********** ****** **** Northern Ireland *** *** 21 December 2005 MHRA Reference: LQ05/3453 Dear Mr Bryce Thank you for your telephone call,requesting information on the side effect homicidal ideation in association with venlafaxine (Efexor). As you may be aware the Yellow Card Scheme is the UK system for collecting and monitoring information on suspected adverse drug reactions (ADRs).The Scheme is run by the MHRA on behalf of the Commission on Human Medicines (CHM). Reports of suspected adverse drug reactions are held on a purpose-designed computer database known as the Adverse Drug Reactions On-line Information Tracking (ADROIT) database. I have searched the ADROIT database and to date we have received a total of 3 suspected Adverse Drug Reaction reports of homicidal ideation in association with venlafaxine. This number is very small when you consider the usage of venlafaxine in the United Kingdom. It is also important to note that the inclusion of a particular reaction on the ADROIT database does not necessarily mean that it has been caused by the drug. Many factors have to be taken into account in assessing causal relationships including temporal association, the possible contribution of concomitant medication, and the underlying disease. The current Product Information Leaflet (PIL) for venlafaxine recognises aggression as a side effect. Further to your question regarding the differences that exist between the product information for venlafaxine in the UK compared with that in the US, with the latter recognising homicidal ideation as a suspected Adverse Drug Reaction. It is important to appreciate that it is not unusual for there to be differences in the UK and US information for medicinal products due to differences in the strengths of the medicines available and sometimes differences in the medical conditions which the products are licensed to treat. SK LQ05/3453.doc 21/12/2005KC 1 I hope this information is helpful Yours sincerely Miss Shahin Kauser BSc (Hons) Senior Pharmacovigilance Scientist Room 15-257 Pharmacovigilance Group Post-Licensing Division