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European Medicines Agency Concludes New Advice To Doctors And Patientsfor Champix Needed
The European Medicines Agency (EMEA) has concluded that updated warnings
to doctors and patients are needed to increase awareness of cases of
suicidal ideation and suicide attempts reported in patients using
Champix (varenicline), a medicine indicated for smoking cessation in
adults.
The Committee for Medicinal Products for Human Use (CHMP) has been
closely monitoring the safety of Champix since it was first authorised
in the European Union (EU) in September 2006. As part of the routine
pharmacovigilance activities, all adverse reactions for Champix are
analysed on a regular basis. Cases of suicidal ideation and suicide were
reviewed in July, October and November 2007.
At its December 2007 meeting, the CHMP concluded that there is a need to
update the product information for Champix to warn doctors and patients
that depression has been reported in patients who are trying to stop
smoking using Champix. The symptoms of this depression may include
suicidal ideation and suicide attempt.
The CHMP has requested that the marketing authorisation holder, Pfizer,
submits a variation to the marketing authorisation for Champix before 19
December 2007 to implement these changes to the product information.
The EMEA will continue to keep this issue under close scrutiny and take
appropriate actions if further concerns arise.
Notes:
1. More information is available in a question-and-answer document here.
2. More information about Champix is available here.
http://www.emea.europa.eu
Agenþiei Europene a Medicamentului concluzioneazã New Sfaturi Pentru a medicilor ºi Patientsfor Champix Necesare - European Medicines Agency Concludes New Advice To Doctors And Patientsfor Champix Needed - articole medicale engleza - startsanatate