Letters and drug alerts sent to healthcare professionals in February 2021
A summary of letters and drug alerts recently sent to healthcare professionals.
Letters
In February 2021, the following letters were sent or provided to relevant healthcare professionals:
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– see accompanying Drug Safety Update, February 2021
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– see also the medicines defect notification below
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Post-publication note: April 2021
Following publication, the MHRA was made aware of an additional letter sent to healthcare professionals in February 2021 regarding Lojuxta (lomitapide) and a reminder to monitor the liver function of patients and to avoid use in pregnancy. This was included in Drug Safety Update April 2021.
Medicines Recalls and Notifications
As of February 2021, the MHRA has replaced ‘Drug alerts’ and ‘company led drug alerts’ with ‘medicines recalls’ and ‘medicine notifications’. No further safety communications will be issued with the ‘alert’ terminology unless they are National Patient Safety Alerts – see article for further information on the changes to the classification system.
Class 3 Medicines Recall: Intrapharm Laboratories Ltd, Kolanticon Gel 500ml, EL (21)A/01. Issued 03 February 2021. A single batch of Kolanticon Gel 500ml has been identified with lumpy product consistency. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Class 2 Medicines Recall: Grünenthal Ltd, Palexia 20 mg/ml Oral Solution (PL 21727/0054). Issued 08 February 2021. Specific batches of Palexia 20 mg/ml Oral Solution have been identified as at risk for microbial contamination with Burkholderia contaminans. All remaining stock within expiry should be quarantined and returned. Pharmacists should contact all patients dispensed this product between December 2017 and February 2021 to determine if they possess affected batches and arrange return to the pharmacy as appropriate.
Class 4 Medicines Defect Information, AmBisome Liposomal 50 mg Powder for dispersion for infusion, (PL 16807/0001), EL (21)A/03v Issued 11 February 2021. The Minisart 5μm sterile filters co-packaged in several batches of AmBisome Liposomal 50mg Powder for dispersion for infusion have been identified as defective. There is no quality issue associated with the AmBisome powder, but the Minisart filters may release fibres and particles which pose a potential risk of thromboembolism. In identified batches, the Minisart filters should be removed and disposed of appropriately. Alternative 5 micron filters should be used. See also accompanying letter for healthcare professionals.
Class 2 Medicines Recall: Eaststone Limited, MidaBuc - Midazolam (as HCL) 10mg/mL Oromucosal Solution, EL (21)A/04. Issued 16 February 2021. A single batch of MidaBuc (Midazolam 10mg/mL oromucosal solution) is being recalled due to underfilled or empty bottles. Stop supplying the batch immediately, quarantine remaining stock and return to supplier.
Class 3 Medicines Recall: SyriMed, Clonidine hydrochloride 50micrograms/5ml Oral Solution, EL (21)A/05. Issued 17 February 2021. A single batch of Clonidine hydrochloride 50 micrograms/5ml oral solution has been identified with defective child-lock container closures due to an issue with bottle capping during manufacture. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Article citation: Drug Safety Update volume 14, issue 8: March: 3.