April 11, 2005
by Angela Hussain

A company which makes an SSRI antidepressant contravened a safety restriction on its use and misquoted national guidance on the treatment of depression, the drug regulatory agency has announced.

Wyeth has been forced to withdraw an information pack about Effexor - now only allowed to be prescribed by psychiatrists - since it has been associated with more adverse drug reactions and deaths than other SSRIs (selective serotonin-reuptake inhibitors)

The Medicines and Healthcare Products Regulatory Agency (MHRA), which was criticised last week by a group of MPs for being too close to the pharmaceutical industry, has begun to name firms breaking rules on drug promotions.

The agency has the power to prosecute in such instances and said it is making clear that repeat offenders risk fines and/or imprisonment in future.

Jeremy Mean, policy group manager at the agency, told societyguardian.co.uk: "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 agency was alerted in January by a healthcare professional 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 Effexor, 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," she said.

The MHRA's action against Wyeth follows a damning report of the MHRA last week by the health select committee.

The report called for the "lax" pharmaceutical regulatory regime to be overhauled, saying it has prioritised the interests of the industry over public safety.

Adverse reactions caused by a number of drugs, such as the SSRI antidepressant Seroxat, have revealed fundamental flaws in the regulatory system, the health select committee report said.

The report called for a wholesale review of the MHRA, saying it has inadequately scrutinised clinical trials for Seroxat and other drugs.

See also:
April 11, 2005: Overhaul drugs regulatory system, MPs urge - the MHRA criticised for prioritising the interests of the industry over public safety.
August 23, 2004: Warning that Effexor antidepressant is associated with increasing number of suicides and accidental fatal overdoses - deaths equivalent to 8.5 for every million prescriptions

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