AUTH/2010/6/07: GP v Sanofi-Aventis — Acomplia claim on cardiometabolic risk factors (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2010/6/07
Parties	General practitioner v Sanofi-Aventis
Product	Acomplia (rimonabant)
Issue	Substantiation of claim that an estimated 50% of effects on cardiometabolic risk factors were beyond those expected from weight loss alone
Trigger	Drug and Therapeutics Bulletin (June 2007) review questioning whether “beyond weight loss” effects were attributable to the medicine
SPC reference cited	Section 5.1 (Pharmacodynamic Properties): “It is estimated that approximately half of the observed improvement in the HDL-C and triglycerides… was beyond that expected from weight loss alone”
Clauses considered	Clauses 7.2 and 7.4
Decision	No breach
Complaint received	11 June 2007
Case completed	2 August 2007
Applicable Code year	2006
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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A general practitioner complained about Sanofi-Aventis’ promotion of Acomplia (rimonabant), focusing on the claim: “An estimated 50% of the effects of Acomplia on Cardiometabolic Risk Factors are beyond those expected from weight loss alone”.
The complainant cited a June 2007 Drug and Therapeutics Bulletin review suggesting any “beyond weight loss” benefits might not be due to the medicine itself, and asked the Panel to reconsider the claim.
The matter was treated as a new complaint under Paragraph 5.1 of the Constitution and Procedure (the claim had previously been considered with no breach in AUTH/1976/3/07).
Sanofi-Aventis responded that the claim reflected the Summary of Product Characteristics (SPC) and was supported by several randomised controlled trials; the Bulletin article was opinion-based and did not introduce new data.

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No breach of the Code was ruled.
The Panel considered the claim a fair reflection of the known data, noting it was qualified (“estimated”) and consistent with the SPC wording.
No breach of Clauses 7.2 and 7.4 was ruled.

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