Merck breached ABPI Code over ‘More GI-friendly’ Glucophage SR ad and illegible prescribing information (AUTH/1802/2/06)

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Key facts

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Case number	AUTH/1802/2/06
Company	Merck
Complainant	Teaching Primary Care Trust Head of Medicines Management
Material	Glucophage SR journal advertisement
Headline claim at issue	“More GI-friendly than IR metformin!”
Publication / placement	Prescriber, 19 February (ad ref December 2005. zz27110)
Key issues	Misleading impression of absolute GI side-effect incidence; prescribing information not clearly legible due to poor contrast
Applicable Code year	2003
Breach clauses	Clause 4.1, Clause 7.2, Clause 7.4
Complaint received	22 February 2006
Case completed	30 March 2006
Appeal	No appeal
Sanctions	Undertaking received

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

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A head of medicines management at a primary care trust complained about a Merck journal advertisement for Glucophage SR (prolonged release metformin) in Prescriber (19 February; ad ref December 2005. zz27110).
The ad’s headline claim was: “More GI-friendly than IR metformin!” The complainant said it could not be substantiated and that no references were provided.
The complainant noted the SPC suggested GI symptoms were very common with Glucophage SR, and said the ad text was so small a magnifying glass was needed.
Merck argued the claim was substantiated by comparative data (including discontinuation and GI event rates) and that the smallest ad version met minimum type-size requirements.
The Panel considered the ad’s presentation (headline placed above a cartoon smiling face on what looked like a belly) implied GI side effects were “not too much of a problem”.
The Panel also reviewed the prescribing information design: thin white text on a flesh-coloured background, creating poor contrast.

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The Panel ruled the headline claim gave a misleading impression of the absolute incidence of GI effects with Glucophage SR and could not be substantiated in the context presented.
The Panel ruled the prescribing information was not easy to read due to poor contrast, breaching the requirement for clear and legible prescribing information.
No appeal.
Undertaking received (sanction recorded on the PMCPA case page).

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