Press release: Updated product information for Efexor (venlafaxine)

Press release

Date:	31 May 2006
Time:	12:00
Subject:	Efexor (venlafaxine)
Contact:	Press Office 020 7084 3651 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) has concluded its review into all the latest safety evidence relating to Efexor (venlafaxine), an anti-depressant belonging to a class of medicines known as serotonin and noradrenaline reuptake inhibitors (SNRIs) The review particularly looked at the risks associated with overdose. 

Updated prescribing advice is designed to minimise the risks of side effects, especially in overdose. The main points are:

• The need for specialist supervision in those severely depressed or hospitalised patients who need doses of 300mg daily or more.
• Cardiac contra-indications are more targeted towards high risk groups.
• As previously, patients with uncontrolled hypertension should not take venlafaxine, and blood pressure monitoring is recommended for all patients.
• Updated advice on possible drug interactions. 
   

In addition, a smaller pack size will soon be available to help minimise the risk of overdose. 

The MHRA is informing healthcare professionals about the updated prescribing advice. The Patient Information Leaflet (PIL) will also be updated, incorporating all the new advice. 

Dr June Raine, MHRA Director said, “We are writing to healthcare professionals to ensure that they are fully informed of the updated information on Efexor to allow them to make informed prescribing decisions. It is very important that patients do not stop their treatment. Patients already taking Efexor should make a routine appointment with their doctor, so that their treatment can be reviewed. For most patients, no changes to their treatment will be needed.” 

A summary of the MHRA report is available at www.mhra.gov.uk . Patients and healthcare professionals are urged to report any suspected adverse reactions to Efexor via the Yellow Card Scheme. They can be completed on the web at www.yellowcard.gov.uk. 

Notes to Editor

The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem.
 

2.   NICE is actively considering the impact of today’s announcement by the MHRA on its clinical guidelines on depression and anxiety. In the meantime, the NICE guidance on depression and anxiety continues to apply, and health professionals should take into account the MHRA's advice when interpreting the recommendations about venlafaxine.