European Medicines Agency Recommends Acomplia Must Not Be Used In Patients On Antidepressants Or With Major Depression

The European Medicines Agency (EMEA) recommended contraindicating
Acomplia (rimonabant) from sanofi-aventis, in patients with ongoing
major depression or who are being treated with antidepressants, because
of the risk of psychiatric side effects. Doctors in the EU have already
been warned about this since June 2006 but the Agency's Committee for
Medicinal Products for Human Use (CHMP) has now recommended upgrading
this warning.



Acomplia has been authorised in the EU since June 2006 as an adjunct to
diet and exercise for the treatment of obese or overweight adult
patients. Psychiatric side effects, in particular depression, were
identified as the main safety issue at the time of approval. They were
reflected in the medicine's product information as a warning that
doctors should not prescribe Acomplia in patients with uncontrolled
serious psychiatric conditions such as major depression.



As part of its continuous monitoring of the safety of medicines, the
CHMP requested sanofi-aventis in June 2007 to submit all available
information on the psychiatric side effects of Acomplia. Finalising the
assessment of the available data at its 16-19 July 2007 meeting, the
CHMP concluded that the benefits of Acomplia continue to outweigh its
risks, except in patients with ongoing major depression or taking
antidepressants.



The CHMP also recommended adding a warning that treatment with Acomplia
should be stopped if a patient develops depression, as well as the
inclusion of additional information on the psychiatric safety of
Acomplia.



Doctors will be sent a letter to inform them about the updated
prescribing information. Patients and their carers should be aware of
the risk of depression in patients taking Acomplia.



The CHMP recommendation will now be forwarded to the European Commission
for adoption of a Decision.



1. For more information, see the accompanying question-and-answer
document
, which also includes the recommended updated product
information (in Annex 1).


2. Acomplia is authorised in the European Union/European Economic
Area, and is marketed in 13 European countries. Rimonabant is also
authorised as Zimulti, but this product is not marketed in the European
Union.


3. The European Public Assessment Report for Acomplia can be found

here.


4. This press release, together with other information on the work
of the EMEA, can be found on the EMEA website: emea.europa.eu.