Letters and drug alerts sent to healthcare professionals in April 2020

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

• From: Medicines and Healthcare products Regulatory Agency
• Published: 21 May 2020

• Therapeutic area: Anaesthesia and intensive care, Cancer, Cardiovascular disease and lipidology, Dermatology, Endocrinology, diabetology and metabolism, GI, hepatology and pancreatic disorders, Haematology, Immunology and vaccination, Immunosuppression and transplantation, Infectious disease, Neurology, Obstetrics, gynaecology and fertility, Paediatrics and neonatology, Psychiatry, Radiology and imaging, Respiratory disease and allergy, Rheumatology, Urology and nephrology

Emerade: recall of 300 and 500 microgram adrenaline auto-injectors

Class 2 Medicines Recall: Emerade 300 micrograms solution for injection in pre-filled syringe, PL 33616/0014 (EL(20)A/20) – issued 7 April 2020

Class 2 Medicines Recall: Emerade 500 micrograms solution for injection in pre-filled syringe, PL 33616/0014 (EL(20)A/20) – issued 18 May 2020

Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 300 and 500 microgram auto-injectors (also referred to as pens) 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. These alerts follow the recall for Emerade 150 microgram auto-injectors on 4 March 2020.

A patient letter is provided with the alert to be provided to all patients and carers, as appropriate, who have been prescribed Emerade auto-injectors.

While Emerade remains unavailable, alternative devices should be considered for patients. There is evidence to suggest that a single EpiPen (300 microgram) or Jext (300 microgram) pen will be a suitable replacement for a single Emerade 500 microgram pen. This is based on recently available results from a study which compared blood levels of adrenaline following injection of Emerade 500 microgram pens with those following EpiPen 300 microgram or Jext 300 microgram pens.

Post-publication note: December 2021.

This Emerade recall is no longer active. Following an MHRA investigation and corrective action by the manufacturer, in November 2021 the MHRA approved Emerade 300 microgram and 500 microgram auto-injectors to be resupplied to the market. Please see Drug Safety Update November 2021 for more information.

Safety letters

In April 2020, the following letters were sent or provided to relevant healthcare professionals about medicines safety issues:

• ReQuip (ropinorole hydrochloride) tablets: important changes to the colour of carton and blister packs

• Cyproterone acetate: restrictions in use of due to risk of meningioma

• Temporary modifications to the Pregnancy Prevention Programmes for thalidomide (Thalidomide Celgene), lenalidomide (Revlimid▼) and pomalidomide (Imnovid▼) – see accompanying article in May 2020 Drug Safety Update
• TRISENOX (arsenic trioxide) – Risk of medication errors due to the introduction of 2 mg/ml concentration

Supply-related letters – April 2020

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

• Noradrenaline (Norepinephrine) 4mg/4ml concentrate for solution for infusion: temporary supply of a different presentation in market and changes to the instructions

• Suxamethonium: temporary foreign label product - Label and patient information leaflet (PIL) is in Portuguese

• Diprivan emulsion (Aspen propofol): Interim supply to Mitigate Supply Disruption of 10mg/ml (1%) Panamanian Stock; 20mg/ml (2%) Brazilian stock; 10mg/ml (1%) stock with Chinese tray label

• Propofol 10mg/ml (1%) Emulsion for Injection/Infusion Interim Supply of Sweden Stock to Mitigate Supply Disruption

• Midazolam 1mg/ml Solution for Injection or Infusion (Midazolam): supply disruption

• Esmeron (rocuronium bromide) 10mg/ml solution for injection: supply of some packs originally for Australia

• Ioversol (Optiray) 300 mg Iodine/ml: 100ml syringe and bottle shortage

• Polivy ▼ (polatuzumab vedotin): 140mg powder for concentrate for solution for injection: temporary plastic vial flip-off cap colour

• Adoport (tacrolimus): limited number of packs with Italian foil - for 0.75mg and 5mg capsules and for 1 mg capsules

Supply-related letters – May 2020

In May 2020 (up to 15 May), 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 from the below countries to Mitigate Supply Disruption

• Sirturo▼100 mg (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

Other drug alerts issued in April 2020

Class 4 Medicines Defect Information: Glaxosmithkline Consumer Healthcare (UK) Trading Limited, various products, EL(20)A/22. Issued 20 April 2020. Due to a machinery defect with the printing line, a small number of packs may not have the batch number and expiry date printed on the outer cartons.

Class 4 Medicines Defect Information: Levofloxacin 500mg Tablets, PL 00289/1047 EL (20)A/21. Issued 16 April 2020. The Product Code/GTIN (PC) number found on the listed batches is incorrect.

Post-publication note

In July 2020, the letter for TRISENOX was added into the list of safety letters for April 2020.

Article citation: Drug Safety Update volume 13, issue 10: May 2020: 4.

Published 21 May 2020