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Recent News and Articles on the Keywords: acomplia must + not recommended + acomplia  Related to the article below (Last Update: 5/12/2008)

Sanofi-aventis: Encouraging First-Quarter 2008 Results Further ...
Earthtimes (press release), UK - Apr 30, 2008
Net sales of Acomplia(R) were EURO 22 million. In March, the National Institute for Health and Clinical Excellence (NICE) -- the organization responsible ...SNY
Source: Google News

Drug treatments for obesity: orlistat, sibutramine, and rimonabant
RS Padwal, SR Majumdar - The Lancet, 2007 - Elsevier
... Second, the benefit?risk ratio of the drug must be favourable. ... with monamine-oxidase
inhibitors or serotoninergic drugs is also not recommended because of ...

OM News -
P Complications - Obesity Management, 2007 - liebertonline.com
... emea.europa.eu/ humandocs/PDFs/EPAR/acomplia/32982607en.pdf ... even when food consump-
tion does not increase ... calorie intake and energy expenditure must be adjusted ...

[PDF] NOTTINGHAM PRESCRIBER
MGONCFCF BECLOMETHASONE, IYC SCHEME, OSSBEU TO, … - ukmicentral.nhs.uk
... starts smoking again, Exubera? must be discontinued ... Rimonabant (Acomplia?) GREY Appetite
suppressant as an ... DTC) and are therefore not recommended for use ...

Emerging Treatments for Diabetes Mellitus Type 1 or Type 2: Recently Approved Medications and More … -
P Emerson, JV Felicetta - Endocrinology, 2006 - residentandstaff.com
... 12. Cannabinoid-1 Receptor Antagonists Rimonabant (Acomplia), currently under ... therapy
but who have not achieved glucose ... until very recently: it must be injected ...

Patient information: Weight loss treatments -
COF OBESITY, SWL GOALS, B MODIFICATION, D THERAPY, … - patients.uptodate.com
... intervention, including drug therapy, must be realistic ... Sibutramine is not recommended
for people with ... Rimonabant ? Rimonabant (Accomplia?) is a cannabinoid ...

Bupropion for weight reduction -
KM Gadde, GL Xiong - Expert Review of Neurotherapeutics, 2007 - ingentaconnect.com
... The EMEA has cautioned that rimonabant treatment is not recommended in patients
taking antidepressants, and it should not be used in patients with serious ...

Drugs on the horizon for diabesity -
CJ Bailey - Current Diabetes Reports, 2005 - Springer
... Exenatide is supplied in injector pens and must not be substituted ... Rimonabant (Acomplia,
SR 141716; Sanofi ... 2. Lazar MA: How obesity causes diabetes: not a tall ...

Pharmaco-economic issues for diabetes therapy -
JM Bottomley, FD Raymond - Best Practice & Research Clinical Endocrinology & Metabolism, 2007 - Elsevier
... inhaled insulins (Exubera ? ), incretins (exenatide, Byetta ? ) and rimonabant
(Acomplia ? ). The appearance of these newer medicines is not yet supported ...
-

[PDF] News -
R PROHIBITED - JAMA, 2002 - bjcardio.co.uk
... It must also be emphasised that beta blockers ... of their new anti-obesity drug, rimonabant
(Acomplia?). ... It is also not recommended for anyone on antidepressant ...

[PDF] Pharmacotherapy as part of a weight management programme: a UK perspective
AH BARNETT - Br J Diabetes Vasc Dis, 2007 - bjdvd.com
... of weight loss that they can attain, they may be useful in patients not responsive
to ... 1999 57 must have lost > 8% of their ORL 60 mg tid (173) 6.16 c (NSS) ...

Source: Google Scholar

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: http://www.emea.europa.eu.
 
 
 
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