Medicines Healthcare Products Regulatory Agency
Valproate National Patient Safety Alert
On 28 November 2023, we issued a National Patient Safety Alert that asked organisations to put a plan in place to implement new regulatory measures for sodium valproate, valproic acid and valproate semisodium (valproate).
This follows a comprehensive review of safety data, advice from the Commission on Human Medicines and an expert group, and liaison with clinicians and organisations. Due to the known significant risk of serious harm to a baby after exposure to valproate in pregnancy, these measures aim to ensure valproate is only used if other treatments are ineffective or not tolerated, and that any use of valproate in women of childbearing potential who cannot be treated with other medicines is in accordance with the Pregnancy Prevention Programme.
From January 2024, valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or unless there are compelling reasons that the reproductive risks do not apply.
Clinicians should discuss the current warnings and upcoming measures relating to valproate with their patients and consider together how it affects the patients individual circumstances. See the Public Assessment Report for the full review of safety data and expert advice on management of the risks.
Letters
Medicine Recalls and Notifications
In November 2023, recalls and notifications for medicines were issued on:
Class 3 Medicines Recall: AstraZeneca UK Ltd., Fluenz Tetra nasal spray suspension, EL(23)A/39 : Issued 30 November 2023. AstraZeneca UK Ltd has informed the MHRA that, following routine stability analysis, the printed expiry dates for named batches of Fluenz Tetra nasal spray suspension are incorrect. As a precautionary measure, the expiry dates need to be reduced by up to 5 days. Healthcare professionals are advised to continue using the vaccine as directed. The vaccines may be administered safely up until the amended expiry date. After the amended expiry date, any unused products should be quarantined for return.
Medical Device Safety Information
We recently published Device Safety Information pages on the following topics:
Specific brands of carbomer eye gel: recall of AACARB eye gel, AACOMER eye gel and PUROPTICS eye gel: potential risk of infection, DSI/2023/11 : Issued 24 November 2023. An investigation by UKHSA has identified a potential association of a Burkholderia cenocepacia bacterial contamination with the named eye gels. As a precautionary measure these eye gels are being recalled. UKHSA considers the risk to the public from Burkholderia cenocepacia to be very low, but some patient groups are at higher risk of adverse effects. Therefore, as a precautionary measure, the UKHSA has recommended all carbomer containing eye gels are avoided in individuals with cystic fibrosis, patients cared for in critical settings (e.g. intensive care), severely immunocompromised individuals, and those awaiting lung transplantation.
Healthcare professionals are advised to follow the actions in the field safety notice including stopping supply or prescription of the named eye gels to all patients/customers (supplied from August to November). For additional information please refer to the?Device Safety Information page.
Article citation: Drug Safety Update volume 17, issue 5: December 2023: 3.