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National Patient Safety Alert: Reducing risks for transfusion-associated circulatory overload (NatPSA/2024/004/MHRA)

On 4 April, we issued a National Patient Safety Alert to highlight the need to reduce risks for transfusion associated circulatory overload (TACO).

TACO is one of the most common causes of transfusion-related deaths in the UK and cases have increased substantially in recent years. Identifying risk factors for TACO prior to transfusion allows initiation of appropriate mitigating measures.

Letters

In April 2024, the following letters were sent or provided to relevant healthcare professionals:

• Levemir InnoLet 100 units/ml solution for injection in pre-filled pen (insulin detemir), Insulatard InnoLet 100 international units/ml suspension for injection in pre-filled pen (insulin isophane human), NovoTwist 5mm needles (32G), NovoFine 6mm needles (31G), NovoFine 8mm needles (30G), NovoFine Autocover needle (30G) and NovoFine Remover: DISCONTINUATION
• Sandimmun concentrate for solution for infusion 50mg/ml (ciclosporin): Interim Supply of German Stock to Mitigate Supply Disruption
• Wegovy 0.5 mg, solution for injection in pre-filled pen (semaglutide): Interim supply of Swiss Stock to Mitigate Supply Disruption
• Mounjaro ?(tirzepatide) 2.5 mg KwikPen solution for injection in pre-filled pen: Extended Use Beyond Printed Expiry Date, Batches D712074, D720751, D720957
• Lanreotide ADVANZ PHARMA 120 mg solution for injection in pre-filled syringe (Lanreotide acetate) Interim Supply of German Stock to Mitigate Supply Disruption
• Adoport (tacrolimus) 0.75mg hard capsules Interim Supply of Nordic Stock
• Tegretol 100 mg/5ml Liquid (Carbamazepine): Temporary stock-out and update to posology (reduction of maximum daily dose)

Medicine Recalls and Notifications

In April 2024, recalls and notifications for medicines were issued on:

Class 3 Medicines Recall: Bristol-Myers Squibb Pharmaceuticals Limited, OPDIVO 10 mg/mL concentrate for solution for infusion (nivolumab), EL(24)A/11. Issued 4 April 2024. Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that a potential product quality issue has been detected, relating to incomplete crimping of the metal crimp cap of OPDIVO 10mg/mL concentrate for solution for infusion (nivolumab) (1VLX10ML). Healthcare professionals are advised to stop using the above batches immediately.

Class 3 Medicines Recall: Accord-UK Ltd, Co-Codamol 8/500mg Effervescent Tablets (Key Pharmaceuticals Livery), EL (24)A/12. Issued 10 April 2024. Accord-UK Ltd is recalling a specific batch of Co-Codamol 8/500mg Effervescent Tablets (Key Pharmaceuticals Livery) as a precautionary measure due to the internal tablet blister strips being printed with an incorrect expiry date. Only packs from the specified batch are affected. Healthcare professionals are advised to stop supplying the above batch immediately.

Class 3 Medicines Recall: A. Menarini Farmaceutica Internazionale Srl, Invokana 300mg tablets (Northern Ireland only), EL(24)A/13. Issued on 16 April 2024. A. Menarini Farmaceutica Internazionale Srl is recalling the above batch as a precautionary measure due to the distribution of Invokana 300mg in Northern Ireland in packaging intended for the Greek market. This affects Invokana 300mg (30 tablets) in Northern Ireland only. Healthcare professionals are advised to stop supplying the above batch immediately.

Class 3 Medicines Recall: Neon Healthcare Ltd, Suprefact 1 mg/ml solution for injection (Cheplapharm Canadian Livery), EL(24)A/14. Issued 23 April 2024. Neon Healthcare Ltd is recalling the specific batch mentioned in this notification as a precautionary measure. This is because the named batch of Suprefact 1mg/ml solution for injection is being distributed in packaging intended for the Canadian market by Cheplapharm, instead of the correct UK packaging. Stop supplying the above batch immediately. Wholesalers are also requested to check stock of Buserelin 1 mg/ml solution for injection for any packs that match Suprefact 1 mg/ml solution for injection (MAH: Cheplapharm Canadian Livery) as per the product images in the alert.

Medical Device Safety Information

We recently published Device Safety Information pages on the following topics:

0.9% Sodium Chloride Solutions for Irrigation, Inhalation, and Eyewash: recall from manufacturer Legency Remedies, DSI/2024/004. Issued on 4 April 2024. Batches of Legency Remedies Pvt Ltd irrigation, inhalation and eye wash saline products manufactured between April and November 2023 are being recalled due to potential microbiological contamination with Ralstonia pickettii (R. pickettii). For additional information please refer to the Device Safety Information page and the Field Safety Notice.

Symbios ORIGIN Posterior Stabilised Patient-Matched Total Knee Replacement Device: Risk of Early Revision, DSI/2024/005. Issued 23 April 2024. The MHRA was alerted by Beyond Compliance and the UK National Joint Registry (NJR) to a significantly higher revision rate observed with the ORIGIN PS patient-matched total knee replacement. The ORIGIN PS variant, raised as a level 1 outlier, demonstrates a revision rate (per 100 patient years) that is at least two times higher than all other bicondylar knee replacements in the UK. This issue currently appears to be UK-specific as other international registries do not show the same increase in early revision surgeries.

As a precautionary measure, Symbios Orthopdie SA has initiated a voluntary suspension of all further sales and implantations, alongside a recall of all variants of the ORIGIN device family within the UK. This will be until such a time that further evidence is gathered and assessed. For additional information, please refer to the Device Safety Information page and the Field Safety Notice.

Article citation: Drug Safety Update volume 17, issue 10: May 2024: 2