Letters and drug alerts sent to healthcare professionals in November 2020

A summary of letters and drug alerts recently sent to healthcare professionals.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 17 December 2020

• Therapeutic area: Anaesthesia and intensive care, Cancer, GI, hepatology and pancreatic disorders, Haematology, Neurology, Paediatrics and neonatology, Respiratory disease and allergy

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Letters

In November 2020, the following letters were sent or provided to relevant healthcare professionals:

• Ondexxya (andexanet alfa): avoid use of andexanet prior to heparinization

• Tecfidera (dimethyl fumarate): updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia

• Gilenya (fingolimod): updated recommendations to minimise the risk of drug-induced liver injury (DILI)

• Rozlytrek (entrectinib) 100mg and 200mg capsules: missing side effect in EU Patient lnformation Leaflet

• Solu-Medrone (methylprednisolone as sodium succinate) 40mg powder and solvent for solution for injection: change from lactose-containing to a lactose-free formulation; risk of serious allergic reactions if formulations are confused

• Gliolan (5-aminolevulinic acid, 5-ALA): what to do in case of delayed surgery and information on fluorescence in non-high-grade glioma

• Propofol 10mg/ml (1%) emulsion for injection/infusion: batches with deactivated data in European Medicines Verification System (EMVS)

• Midazolam maleate (Epistatus 10mg in 1ml oromucosal solution, multidose bottle), unlicensed, emergency use medication for prolonged, acute, convulsive seizures: potential risk of incorrectly engaged child-resistant container closures

Drug alerts

Class 4 Medicines Defect Information, Kolanticon Gel 200ml, (PL 17509/0084), EL (20) A/51. Issued 9 November 2020. For one batch of this product, there is a difference in dosage instructions between the carton and label – the Patient Information Leaflet (PIL) and bottle label contain the correct instructions. When dispensing or providing this product, please check batch number and ensure that patients are aware of the correct dosing instructions.

Class 2 Medicines Recall, medac GmbH (T/A medac Pharma LLP) Sodiofolin 50mg/ml Solution for Injection 100mg/2ml, PL 11587/0005, EL (20) A/52. Issued 11 November 2020. A specific batch is being recalled as a precautionary measure due to some inspected vials showing hairline damage to the shoulder of the vials. Stop supplying the batch immediately and return to supplier.

Class 2 Medicines Recall, Mylan UK Healthcare Ltd, Ancotil 2.5 g/250 ml Solution for Infusion, PL 46302/0116, EL (20) A/53. Issued 12 November 2020. Remaining stock of certain batches is being recalled as a precautionary measure after a product sterility non-compliance during a recent inspection at the contract manufacturing site. Stop supplying the batches immediately and return to supplier.

Class 2 Medicines Recall: Kyowa Kirin Limited, Abstral 200 microgram sublingual tablets, EL (20)A/54. Issued 25 November 2020. Specific batches are being recalled as a precautionary measure due to reports of double tablets in a single-blister pocket. Stop supplying the batches immediately and return to supplier.

Class 2 Medicines Recall: Kent Pharmaceuticals Ltd, Betahistine dihydrochloride 8mg and 16mg Tablets, EL (20)A/55. Issued 26 November 2020. Affected batches are being recalled following contamination with theophylline due to a cross-contamination issue identified with an excipient used in the manufacture of the finished product. Stop supplying the batches immediately and return to supplier.

Class 2 Medicines Recall: Aventis Pharma Limited (t/a Sanofi), Largactil 50mg/2ml Solution for Injection, EL (20)A/56. Issued 26 November 2020. Specific batches of Largactil 50mg/2ml Solution for Injection are being recalled as a precautionary measure due to out of specification results obtained for the impurity chlorpromazine sulphoxide. Stop supplying immediately and return to supplier.

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Article citation: Drug Safety Update volume 14, issue 5: December 2020: 4.

Published 17 December 2020