AUTH/2885/11/16: Anonymous v Gedeon Richter — Esmya patient support leaflet misstated contraception interaction | PMCPA Case

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Key facts

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Case number	AUTH/2885/11/16
Complainant	Anonymous, non-contactable (described themselves as a senior grade doctor in obstetrics and gynaecology)
Company	Gedeon Richter (UK) Ltd
Medicine	Esmya (ulipristal acetate)
Material	Patient support leaflet (tear-off sheets), ref UK/ESM5/0416/0033
Main issue	Leaflet warned only against “oral contraceptives” rather than all hormonal contraception, despite SPC interaction information; potential patient-safety risk
Applicable Code year	2016
Breach clauses	Clause 2; Clause 7.2; Clause 9.1
Complaint received	2 November 2016 (PDF); 03 November 2016 (PMCPA webpage)
Undertaking received	6 December 2016
Appeal	No appeal (case completed at Panel level; Appeal Board considered additional sanctions)
Additional sanctions	Corrective statement required to health professionals who may have received the leaflet; advertisement listed
Corrective statement sent	30 March 2017

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

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An anonymous (non-contactable) complainant, describing themselves as a senior obstetrics & gynaecology doctor, complained about an Esmya (ulipristal acetate) patient support leaflet (ref UK/ESM5/0416/0033) produced by Gedeon Richter (UK) Ltd.
Esmya was indicated for the pre-operative or intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
The leaflet told patients: “You should not take oral contraceptives whilst you are on ESMYA treatment because the two drugs might interact. Ask your healthcare professional if you are not sure”.
The complainant alleged the leaflet was unsafe because it did not warn against other hormonal contraception (eg Mirena coil, injections), despite the SPC indicating Esmya may interfere with hormonal contraceptives and vice versa.
Gedeon Richter said the leaflet was being revised following customer feedback; a revised version broadening the wording to “hormonal contraception” was certified on 4 November 2016 and the previous version was withdrawn from use on 4 November 2016.
The Panel noted the SPC (sections 4.4/4.5) covered multiple hormonal methods (progestogen-only pills, progestogen-releasing devices, combined oral contraceptives) and that pregnancy was a contraindication (section 4.3).
The Panel emphasised each piece of material must be capable of standing alone; reliance on the pack leaflet was not sufficient.

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The Panel ruled the patient support leaflet statement was inaccurate and misleading and that high standards had not been maintained.
Breaches were ruled of Clauses 7.2, 9.1 and 2.
The company provided an undertaking and assurance (case completed at Panel level; no appeal).
The Appeal Board, concerned about patient safety, imposed additional sanctions requiring a corrective statement to health professionals who had received the leaflet.

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