Freedom of Information request the number of Yellow Card reports you have received on the Besin's pump action oestrogen gel that goes by the names of Oestrogel, Estrogel or Oestrodose.(FOI 21/1286)
Published 31 May 2022
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FOI 21/1286
14th December 2021
Dear
Thank you of your email dated 3rd December 2021, where you requested the following:
- The number of Yellow Card reports you have received on the Besin’s pump action oestrogen gel that goes by the names of Oestrogel, Estrogel or Oestrodose.
Further to your request, I can confirm that the MHRA has received 741 spontaneous UK suspected adverse drug reaction (ADR) reports concerning the use of Oestrogel, Estrogel and Oestrodose, reported between 01/01/2020 and 08/12/2021 (data extracted on 09/12/2021). Please note that brand name is not a required field when submitting a Yellow Card report to the MHRA, therefore this number only includes reports where the brands you requested are specifically reported and not those where the substance is reported. A breakdown of the number of reports per product is given in Table 1. As more than one product can be reported as the suspect drug in any individual case, the total number of reports per product may not be equal to the overall combined number of reports given above.
Table 1: Number of UK Spontaneous ADR reports associated with Oestrogel, Estrogel and Oestrodose.
| Product | Number of Yellow Cards |
|---|---|
| Oestrodose | 160 |
| Oestrogel | 570 |
| Estrogel | 51 |
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.
As you are aware the MHRA received a number of reports in 2020 reporting Oestrodose being less effective than Oestrogel and/or raising concerns about the labelling of these products, possibly as a result of social media posts and podcasts about these products. For this reason the number of reactions reported in 2020 was raised compared to the usual pattern for this product, however the number of reports was not high in absolute terms.
Both Oestrogel and Oestrodose are made by the same manufacturer in an identical manner and in the same factory, so it is expected that they work equally well. However, since we have received this influx of cases over a short period of time, we and our colleagues in the Defective Medicines department within the MHRA have been investigating whether any factors in the manufacturing or supply chain could account for these reports. This has included confirming with the manufacturer that no changes in manufacturing process have occurred and requesting additional information from reporters, where appropriate, to identify whether specific batches may have been affected. Investigations to date have not suggested any underlying issues, and we have not issued any recalls for the concerned products. Therefore, Oestrodose and Oestrogel can continue to be prescribed and dispensed as usual. It should also be noted that the rate of influx of these cases has greatly reduced in 2021, therefore suggesting that any potential batch related issues may now be resolved. However, we are continuing to monitor these reports and will undertake further investigations if needed.
I hope the information provided is helpful, but 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 DivisionFOI 21/1286
14th December 2021
Dear
Thank you of your email dated 3rd December 2021, where you requested the following:
- The number of Yellow Card reports you have received on the Besin’s pump action oestrogen gel that goes by the names of Oestrogel, Estrogel or Oestrodose.
Further to your request, I can confirm that the MHRA has received 741 spontaneous UK suspected adverse drug reaction (ADR) reports concerning the use of Oestrogel, Estrogel and Oestrodose, reported between 01/01/2020 and 08/12/2021 (data extracted on 09/12/2021). Please note that brand name is not a required field when submitting a Yellow Card report to the MHRA, therefore this number only includes reports where the brands you requested are specifically reported and not those where the substance is reported. A breakdown of the number of reports per product is given in Table 1. As more than one product can be reported as the suspect drug in any individual case, the total number of reports per product may not be equal to the overall combined number of reports given above.
Table 1: Number of UK Spontaneous ADR reports associated with Oestrogel, Estrogel and Oestrodose.
Product
Number of Yellow Cards
Oestrodose
160
Oestrogel
570
Estrogel
51
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.
As you are aware the MHRA received a number of reports in 2020 reporting Oestrodose being less effective than Oestrogel and/or raising concerns about the labelling of these products, possibly as a result of social media posts and podcasts about these products. For this reason the number of reactions reported in 2020 was raised compared to the usual pattern for this product, however the number of reports was not high in absolute terms.
Both Oestrogel and Oestrodose are made by the same manufacturer in an identical manner and in the same factory, so it is expected that they work equally well. However, since we have received this influx of cases over a short period of time, we and our colleagues in the Defective Medicines department within the MHRA have been investigating whether any factors in the manufacturing or supply chain could account for these reports. This has included confirming with the manufacturer that no changes in manufacturing process have occurred and requesting additional information from reporters, where appropriate, to identify whether specific batches may have been affected. Investigations to date have not suggested any underlying issues, and we have not issued any recalls for the concerned products. Therefore, Oestrodose and Oestrogel can continue to be prescribed and dispensed as usual. It should also be noted that the rate of influx of these cases has greatly reduced in 2021, therefore suggesting that any potential batch related issues may now be resolved. However, we are continuing to monitor these reports and will undertake further investigations if needed.
I hope the information provided is helpful, but 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