Letters and drug alerts sent to healthcare professionals in May 2020

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

Coronavirus (COVID-19) updates

Healthcare professionals are reminded that the MHRA continue to provide guidance related to coronavirus (COVID-19), including for medicines, on our dedicated guidance page.

Hydroxychloroquine

On 8 June 2020, we instructed UK clinical triallists using hydroxychloroquine to treat or prevent coronavirus (COVID-19) to suspend recruitment of participants until further data which justifies continuation have been provided, and any additional safety measures have been implemented.

On 17 June, we received a request from the University of Oxford to recommence recruitment to the ‘COPCOV’ trial investigating hydroxychloroquine in prevention of COVID-19.

The submitted justifications and supporting information were reviewed by us with independent advice obtained from the Commission on Human Medicines (CHM).

On 26 June, it was agreed that sufficient risk mitigation measures had been taken to support recruitment of further participants. These measures included those already in place and additional requested steps including enriching the data collection for comorbidities, additional DSMB oversight, and a specific interim analysis.

Please see our website for more information.

Dexamethasone

On 16 June 2020, the Chief Medical Officer (CMO) issued an alert (see alert on Central Alerting System) confirming that dexamethasone has been demonstrated to have a clear place in the management of hospitalised patients with COVID-19. There were no excess harms identified in using 6mg once per day (either by mouth or by intravenous injection) of dexamethasone in the patient population. Dexamethasone was not used in pregnant women.

Clinicians should therefore consider dexamethasone for the management of hospitalised patients with COVID-19 who require oxygen or ventilation. Out of hospital treatment is not appropriate.

See Drug Safety Update article from May 2020 on using the new dedicated COVID-19 Yellow Card site to report suspected side effects in COVID-19 treatment.

Letters

In May 2020, the following letters were sent or provided to relevant healthcare professionals to support the supply of medicines in the UK:

Up to 15 June 2020, we are aware of the following letters sent or provided to relevant healthcare professionals to support the supply of medicines in the UK:

Drug alerts

Reminder of Emerade recall alerts

Class 2 Medicines Recall: Emerade 500 micrograms solution for injection in pre-filled syringe, PL 33616/0015 (EL(20)A/23. Issued 18 May 2020. We remind healthcare professionals that Emerade 500 microgram pre-filled syringes (pens) were recalled from patients due to an error in one component of the auto-injector believed to cause some pens to fail to activate and deliver adrenaline. See summary in May 2020 Drug Safety Update.

Other drug alerts issued in May 2020

Company led drug alert - Duavive (conjugated oestrogen/bazedoxifene acetate) 0.45mg/20mg Modified Release Tablets – EU/1/14/960/001. Issued 27 May 2020. As a precautionary measure, batches from wholesalers are being recalled due to out-of-specification results from ongoing stability studies. An evaluation of the foil laminate pouch identified oxygen levels above the specified limits, resulting in lower dissolution results for bazedoxifene acetate.

Class 4 Medicines Defect Information: Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection, EL (20)A/24. Issued 28 May 2020. The carton label on sodium benzoate (Amzoate) 2g in 10mL sterile solution for injection incorrectly states the concentration of disodium edetate (excipient) as 0.1% w/v (10mg in 1mL) instead of 0.1% w/v (10mg in 10mL). Healthcare professionals are advised to exercise caution when dispensing and administering the product.

See all Drug Alerts and Medical Device Alerts from the MHRA.

Article citation: Drug Safety Update volume 13, issue 11: June 2020: 3.

Updates to this page

Published 29 June 2020