FOI release

Freedom of Information request on the yellow card reports following rocuronium (FOI 21/1091)

Published 27 April 2022

22nd October 2021

FOI 21/1091

Dear

Thank you of your email dated 27 September 2021, where you requested data on all fatal cases associated with rocuronium.

Yellow Card data is releasable to members of the public provided that patient and reporter confidentiality is maintained. Under the Freedom of Information Act (FOIA) 2000, the data for this request has been provided as category Ib. For this FOI, the line listings contain the following fields:

• Patient age categories (as aggregated data)

• Patient gender categories (as aggregated data)

• Suspect drug(s)

• Dose of suspect drug(s)

• Route of administration

• Suspected adverse drug reaction(s)

• Adverse drug reaction outcome(s)

• Time to onset

• Past medical history

I can confirm that we have received 15 UK spontaneous suspected ADR reports in association with rocuronium and a fatal outcome up to and including 21/10/2021. The information is presented in Table 1a and aggregated patient age and sex data are presented in tables 1b and 1c.

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

• The fact that symptoms or events occur after use of a medicine or vaccine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by the medicine or vaccine. 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.

Any emerging evidence relating to possible risks associated with rocuronium is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed. As the data provided does not necessarily refer to proven side effects, you should refer to the product information which can be found here: https://products.mhra.gov.uk/ for details on the possible side effects of rocuronium.

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.

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