Letters and drug alerts sent to healthcare professionals in May 2020

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

• From: Medicines and Healthcare products Regulatory Agency
• Published: 29 June 2020

• Therapeutic area: Anaesthesia and intensive care, Cancer, Cardiovascular disease and lipidology, Endocrinology, diabetology and metabolism, Immunology and vaccination, Immunosuppression and transplantation, Infectious disease, Respiratory disease and allergy, Rheumatology

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

Supply-related letters – May 2020

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

• Ativan 4mg/ml Solution for Injection (Lorazepam): Temporary supply of a different presentation and changes to the instructions - US product

• Calrecia, 100mmol/l, solution for infusion (calcium chloride): Interim Supply of stock to Mitigate Supply Disruption

• Sirturo▼100mg (bedaquiline): Interim Supply of Irish Stock to Mitigate Supply Disruption

• Pancuronium bromide 2mg/ml: Temporary supply of alternative US product 10mg/10ml (1mg/ml) multiple-dose fliptop glass vials

• Clozaril 25 mg tablets (clozapine): interim Supply of Danish and Swedish Stock to Mitigate Supply Disruption

• Verorab (Rabies Vaccine, Inactivated) Important information for healthcare professionals due to import of Verorab due to a shortage of UK licensed Rabies Vaccine

• Benlysta▼ (belimumab) pre-filled pen: short-term availability of pen for subcutaneous (SC) administration during COVID-19 pandemic in the UK for existing patients receiving belimumab for injection intravenous (IV) administration– letter for England, letter for Scotland

• Clenil Modulite 100mcg (beclometasone): release of batches of different appearance and without dose indicator; actions needed from dispensers

Supply-related letters – June 2020

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:

• Semglee▼ 100 units/ ml x 3ml prefilled pens (Insulin glargine): Interim Supply of Polish Stock to Mitigate Supply Disruption

• Finomel emulsion for infusion (1435ml - 1101320): interim supply of Belgian stock to mitigate supply disruption (42% glucose solution, a 10% amino acid solution with electrolytes, and a 20% lipid emulsion)

• Adoport (tacrolimus) 2mg capsules: limited number of packs with Italian, Spanish , Dutch, and Nordic blisters foil

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.

Published 29 June 2020