Freedom of Information request on intravenous fluorescein (FOI 21/688)
Published 29 December 2021
© Crown copyright 2021
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-5-july-2021/freedom-of-information-request-on-intravenous-fluorescein-foi-21688
5th July 2021
FOI 21/688
Dear
Thank you for your Freedom of Information (FOI) request dated 7th June 2021.
Under the Freedom of Information (FOI) act you have asked if we have seen an increase in reactions in other eye units for intravenous fluorescein and any further information we have on the cases you have submitted: GB-MHRA-EYC 00252624 and GB-MHRA-EYC 00252617.
The Yellow Card scheme relies on voluntary reporting of suspected side effects or medical device incidents by health professionals and the public, including patients, carers and parents. Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the medicine may have caused the symptoms. As reporting is voluntary, we do not know the number of reactions occurring, only the number of reports received. It is also important to note that reported adverse reactions have not been proven to be related to the drug and should not be interpreted as a list of known side effects. Please note that fluorescein SPC lists hypersensitivity as possible side effects.
You can view the number of reports we have received using our interactive Drug Analysis Profiles (iDAP). Each iDAP contains complete data for all UK spontaneous suspected adverse drug reactions, or side effects, which have been reported on that drug substance to the MHRA. It is important to read the information on essential context at the bottom of each iDAP to understand how to interpret the data.
Please see the following iDAP link for the list of fluorescein Yellow Card reports we have on our system. You can filter the reports based on route of administration as well as by year the report was received. https://info.mhra.gov.uk/drug-analysis-profiles/dap.html?drug=./UK_EXTERNAL/NONCOMBINED/UK_NON_000981431842.zip&agency=MHRA
On review, we have not seen an overall increase in reporting for intravenous fluorescein. Please be assured that all reports received are promptly entered onto the MHRA’s Adverse Drug Reaction (ADR) database so that they are available for a process called signal detection. During signal detection, reports are evaluated along with additional sources of information, such as clinical trial data, medical literature reports and information provided by other international medicines regulators. This information is assessed on a continual basis to see whether a new side effect is identified, or the safety profile of the medicine or vaccine has changed.
If it is considered that a medicine may be causing the symptoms, the MHRA will look at the risk of the side effects in relation to its benefits to consider whether regulatory action is needed. The MHRA takes action, whenever necessary, to ensure that medicines are used in a way that minimises risk, while maximising patient benefit. We will then communicate to healthcare professionals and the public any advice that we give and regulatory decisions that we make about the safety of medicines and vaccines. One way in which we publish the latest information is through our Drug Safety Update website https://www.gov.uk/drug-safety-update. I can confirm that we have assessed GB-MHRA-EYC 00252624 and GB-MHRA-EYC 00252617 through our routine signal detection procedures and I can also confirm that we have no other reports from the batch numbers you have reported (311756F and 318663F). At this point we do not consider any regulatory action necessary however, as with all medicines, we will continue to monitor any new information received.
Please let us know if you have any specific concerns of an increase in reactions to this product; if so we would be grateful for further information.
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