Anonymous v Gedeon Richter

Esmya patient support leaflet

‘Corrective statement

Between July and November 2016, a patient support leaflet for Esmya (ulipristal acetate) (ref UK/ESM5/0416/0033) produced by Gedeon Richter (UK) Ltd was circulated. Esmya is indicated for the pre-operative or intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

You are being sent this corrective statement because you may have received the Esmya patient support leaflets to pass on to your patients when you prescribed them Esmya.

Following a complaint under the ABPI Code of Practice for the Pharmaceutical Industry, the Code of Practice Panel ruled that the patient support leaflet was inaccurate and misleading in that it only told the woman that she should not take oral contraceptives whilst on Esmya whereas she should have been told not to use hormonal contraceptives whilst taking Esmya. The Panel ruled that Gedeon Richter had failed to maintain high standards and had brought discredit upon and reduced confidence in the pharmaceutical industry. As a result of the above and concerns about patient safety, the Code of Practice Appeal Board has required Gedeon Richter to issue this corrective statement and to circulate a copy of the published report for the case which contains full details. This is enclosed.

If you have any remaining copies of the above patient support leaflet please dispose of them.

In addition, where relevant, please draw this issue to the attention of any GP to whom you might have referred patients for repeat prescriptions of Esmya.

On 30 March, 2017 Gedeon Richter sent copies of the case report and the company's corrective statement to relevant hospital doctors.