Acomplia, Inn Rimonabant
European Medicines Agency
Press office
London, 23 October 2008
Doc. Ref. EMEA/CHMP/537777/2008
PRESS RELEASE
The European Medicines Agency recommends suspension of the marketing
authorisation of Acomplia
The European Medicines Agency (EMEA) has recommended the suspension of the marketing
authorisation for Acomplia (rimonabant) from Sanofi-Aventis. The EMEA’s Committee for Medicinal
Products for Human Use (CHMP) has concluded that the benefits of Acomplia no longer outweigh its
risks and the marketing authorisation should be suspended across the European Union (EU).
Acomplia has been authorised in the EU since June 2006 as an adjunct to diet and exercise for the
treatment of obese patients or overweight patients with associated risk factors. Warnings about
psychiatric side effects, in particular depression, have been included in the product information since
Acomplia was first authorised. The product information for Acomplia has been continuously updated
and strengthened to include further contraindications and upgraded warnings on these concerns to
manage the risks associated with the use of Acomplia.
Following the assessment of the available information on the benefits and risks of Acomplia including
data from studies completed since it was granted marketing authorisation, the CHMP confirmed at its
20-23 October meeting, that there is an approximate doubling of the risk of psychiatric disorders in
obese or overweight patients taking Acomplia compared to those taking placebo.
The CHMP considered that the new data from post-marketing experience and ongoing clinical trials
indicated that serious psychiatric disorders may be more common than in the clinical trials used in the
initial assessment of the medicine. The CHMP was also of the opinion that these psychiatric side
effects could not be adequately addressed by further risk minimisation measures.
In addition, the CHMP noted, that the effectiveness of Acomplia in clinical practice is more limited
than was expected on the basis of the clinical trials, because available data indicate that patients
generally take Acomplia only for a short period.
Prescribers should not issue any prescriptions for Acomplia and should review the treatment of
patients currently taking the medicine. Patients who are currently taking Acomplia should consult their
doctor or pharmacist at a convenient time to discuss their treatment. There is no need for patients to
stop treatment with Acomplia immediately, but patients who wish to stop can do so at any time.
Patients currently included in clinical trials with Acomplia should contact the investigator, who will be
able to provide more information.
The CHMP opinion will now be sent to the European Commission for the adoption of a decision,
applicable in all EU countries.
-- ENDS --
Notes:
1.
More information is available in a question and answer document
2.
The suspension of a marketing authorisation is a precautionary measure, during which time a
medicinal product is not available. The lifting of the suspension is conditional on the marketing
authorisation holder resolving the issues identified by the Agency
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09
E-mail: mail@emea.europa.eu http://www.emea.europa.eu
3.
Acomplia is marketed in 18 Member States (Austria, Belgium, Cyprus, Denmark, Estonia,
Finland, France, Germany, Greece, Ireland, Italy, Lithuania, Malta, the Netherlands, Slovakia,
Spain, Sweden and the United Kingdom). Rimonabant is also authorised as Zimulti. Zimulti is
not marketed in the EU.
4.
In July 2007, the CHMP recommended contraindicating Acomplia in patients with ongoing major
depression or who are being treated with antidepressants. Furthermore, in May 2008, the CHMP
recommended updating the product information to reflect the fact that depression may occur as a
side effect of Acomplia in patients who have no obvious risk factors apart from obesity itself, and
to advise prescribers to monitor patients for signs and symptoms of psychiatric disorders,
particularly depression, after the start of treatment.
5.
The review of Acomplia was initiated under Article 20 of Regulation (EC) No 726/2004. This
type of procedure is initiated when there are public health concerns with a centrally authorised
medicine. The European Commission asked the CHMP to assess all aspects of safety of the
centrally authorised medicines containing rimonabant and to give its opinion on the measures
deemed necessary to ensure the safe use of rimonabant and on whether the marketing
authorisation for these products should be maintained, varied, suspended or withdrawn.
6.
More information on Acomplia is available in the European Public Assessment Report (EPAR)
on the Agency’s website:
http://www.emea.europa.eu/humandocs/Humans/EPAR/acomplia/acomplia.htm
7.
This press release, together with other information on the work of the EMEA, can be found on the
EMEA website: www.emea.europa.eu
Media enquiries only to:
Martin Harvey Allchurch or Monika Benstetter
Tel. (44-20) 74 18 84 27, E-mail press@emea.europa.eu
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