Gamble Pharmaceuticals UK
📋 Case Summary
What happened Roche Products Limited and GlaxoSmithKline UK Ltd complained about an Actonel (risedronate) exhibition panel (ref ACT3664) used by Sanofi-Aventis and Procter & Gamble Pharmaceuticals UK Ltd (Alliance for Better Bone Health, ABBH). The panel was displayed at the British Society of Geriatrics meeting in Harrogate (21–23 November 2007) and related materials were also shown at the National Osteoporosis Society meeting in Edinburgh (26–28 November 2007). The complaint focused on tolerability/safety claims and presentation of gastrointestinal (GI) warnings, including use of Taggart et al (2002), a pooled analysis of nine studies using Actonel 5mg daily. Complainants alleged the panel’s claims were inconsistent with the Actonel SPC and used data outside the product licence (including that 1.7% of Taggart et al participants were men or premenopausal women, not licensed for Actonel 5mg). Complainants also argued the SPC class warning about oesophagitis/oesophageal ulcerations
📌 Clauses Breached
NONE