FOI release

Freedom of Information request about Estrodose Yellow Card reports (FOI-21-150)

Published 7 May 2021

8th March 2021

Dear

FOI 21/150

Thank you for your FOI request dated 8th February 2021, where you requested the following information:

How many yellow card reports the MHRA has received for Estrodose in the last 14 months.

Further to your request, I can confirm that the MHRA has received 136 spontaneous UK suspected adverse drug reaction (ADR) reports concerning the use of Oestrodose, reported between 01/01/2020 and 25/02/2021 (data extracted on 26/02/2021). Please note that medicine brand is not a required field when submitting a Yellow Card report to the MHRA, therefore this number only includes reports where the brand was specifically reported as Oestrodose.

When considering the spontaneous Adverse Drug Reaction (ADR) data, it is important to be aware of the following points:

• A reported reaction does not necessarily mean it has been caused by the medicine, only that the reporter had a suspicion it may have. The fact that symptoms or events occur after use of a medicine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by the medicine. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

• It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity about a drug. During the summer of 2020 there were a number of social media posts and podcasts about Oestrodose (a parallel import product) being substituted for Oestrogel; 116 of the 136 reports were received between 23 June 2020 and 31 August 2020 and 114 of these concerned this issue.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team, Vigilance and Risk Management of Medicines Division

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