Bayer: Yasmin journal ad implied non-licensed benefits (AUTH/2383/2/11)

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Key facts

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Case number	AUTH/2383/2/11
Complainant	Anonymous and non-contactable general practitioner
Company	Bayer Healthcare
Medicine	Yasmin (ethinylestradiol and drospirenone)
Material	Journal advertisement (ref UK.PH.WH.YSM.2010.119) published in Pulse, 26 January 2011
Licensed indication referenced	Oral contraception
Main issue	Overall impression encouraged prescribing for non-licensed benefits (acne, fluid retention, hirsutism, premenstrual symptoms) and underplayed side effects vs SPC
Breach clauses	2, 3.2, 7.2, 7.9
Complaint received	7 February 2011
Case completed	24 March 2011
Applicable Code year	2008
Appeal	No appeal
Sanctions applied	Undertaking received

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

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An anonymous, non-contactable GP complained about a Yasmin (ethinylestradiol/drospirenone) journal advertisement published in Pulse (26 January 2011) by Bayer Healthcare.
The ad headline and branding included: “Yasmin. It’s for more women than you might imagine” and the strapline “Contraception and more”.
A bullet point claimed Yasmin “has also been shown to have a beneficial effect vs baseline on acne, fluid retention, hirsutism and premenstrual symptoms”.
The complainant said the ad read as if it was asking him to prescribe Yasmin for those conditions and noted that at least three were listed as adverse events in the Yasmin SPC.
The ad included small-print statements that Yasmin was licensed for oral contraception and “not licensed as a treatment for acne, hirsutism, fluid retention or premenstrual symptoms”, and noted “^A non-comparative study”.
Bayer argued the claims were factual, supported by studies and consistent with the SPC, and referenced prior MHRA correspondence about fluid retention claims.

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The Panel ruled the advertisement was misleading overall and inconsistent with the SPC.
The Panel considered the overall impression encouraged prescribing for non-licensed clinical effects (acne, fluid retention, hirsutism, premenstrual symptoms), despite the disclaimers.
The Panel ruled the ad underplayed side effects by stating “acne and fluid retention may be uncommon side effects of COC use” when the SPC stated both had been reported during use with Yasmin.
No evidence was found that patient safety had been adversely affected, but the Panel considered the implications serious.

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