Freedom of Information request about suspected adverse reactions for Intravenous administration of Venofer to dialysis patients in the UK over the past 10 years (FOI-21-273)
Published 28 May 2021
© Crown copyright 2021
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Thank you for your enquiry dated the 17th March, where you requested information regarding suspected adverse reactions for Intravenous administration of Venofer to dialysis patients in the UK over the past 10 years.
Further to your request we have received a total of 10 UK, spontaneous suspect adverse drug reaction (ADR) reports of Venofer use in dialysis patients from 01/01/2011 to 01/04/2021. These were identified in our database where dialysis was reported in the patients past medical history. Please find the enclosed sheet showing table 1: line listing for these reports, table 2: aggregated patient sex and table 3: aggregated patient age.
To note, past medical history is not a mandatory field on a Yellow Card report and therefore is not always provided. Consequently, there may be reports which occurred in dialysis patients but due to the lack of information we cannot determine this.
When considering the provided 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 drug, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a drug, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the drug. 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. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time. For these reasons the enclosed data should not be used as a basis for determining incidence of side effects.
The MHRA continuously monitors the safety of medicines and vaccines through a variety of pharmacovigilance processes including the Yellow Card scheme. As part of our signal detection processes all adverse reaction reports received by the Yellow Card scheme are individually assessed and cumulative information reviewed at regular intervals. Any emerging evidence relating to possible risks associated with vaccines and medicines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.
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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