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MHRA bans Wyeth pack

Wyeth has undermined an urgent safety restriction on its antidepressant drug, the MHRA has said.

A pharmaceutical company has been found to have undermined an urgent safety restriction on its antidepressant drug and misquoted official guidance on the treatment of depression so as to favour its product.

Wyeth has been forced to withdraw an information pack about the drug Efexor, which is now only allowed to be prescribed by specialists in mental health since it has been associated with more deaths and other side effects than others in its class.

The government's Medicines and Healthcare products Regulatory Agency (MHRA) has recently begun to name and shame companies breaking strict rules on drug promotions but this is the most high-profile shot across the bows yet fired at any erring manufacturer.

The agency has the power to prosecute in such instances and is making clear that repeat offenders risk fines and/or imprisonment in future. Jeremy Mean, policy group manager at the agency, said: "When it comes to safety issues, the MHRA will not tolerate advertising material - written or the spoken word - which has the potential to mislead healthcare professionals or the public. In naming and shaming Wyeth, we hope this message will be clearly understood by all involved in medicines promotion."

The rebuke to Wyeth comes amid unease at the power of the drug companies - MPs on the Commons health select committee earlier this week criticised what they saw as lax controls - although the government insists it is introducing big changes.

The Committee on Safety of Medicines, which advises the MHRA, insisted on new restrictions on antidepressants in the class known as SSRIs in December last year. The agency said it was alerted in January by a healthcare professional who was concerned that Wyeth representatives were distributing "written and verbal material that cast doubt on the validity" of the Committee on Safety of Medicines' recommendations to restrict the use of Efexor, also known as venlafaxine.

A Wyeth spokeswoman said it was challenging the safety advice given by the medicines committee. "Wyeth disagrees with the advice regarding venlafaxine and we are appealing against this."

2nd September 2008

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