firm's advert went against safety advice, regulatory body says
by Angela Hussain
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.
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)
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.
agency has the power to prosecute in such instances and said it
is making clear that repeat offenders risk fines and/or imprisonment
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.
naming and shaming Wyeth, we hope this message will be clearly understood
by all involved in medicines promotion."
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.
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
MHRA's action against Wyeth follows a damning report of the MHRA
last week by the health select committee.
report called for the "lax" pharmaceutical regulatory
regime to be overhauled, saying it has prioritised the interests
of the industry over public safety.
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.
report called for a wholesale review of the MHRA, saying it has
inadequately scrutinised clinical trials for Seroxat and other drugs.
April 11, 2005:
Overhaul drugs regulatory system, MPs urge - the MHRA criticised
for prioritising the interests of the industry over public safety.
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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