Letters and drug alerts sent to healthcare professionals in October 2018

Letters were sent to healthcare professionals about Jext adrenaline autoinjectors, rivaroxaban, Ozurdex 700 micrograms intravitreal implant, sildenafil, hydrochlorothiazide, and Epilim Chronosphere (sodium valproate). We also highlight alerts sent about adrenaline autoinjector and Epanutin (phenytoin) supply disruption and a recall notice for Ozurdex 700 micrograms intravitreal implants.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 14 November 2018

• Therapeutic area: Anaesthesia and intensive care, Cancer, Cardiovascular disease and lipidology, Dentistry, Dermatology, GI, hepatology and pancreatic disorders, Haematology, Neurology, Obstetrics, gynaecology and fertility, Ophthalmology, Paediatrics and neonatology, Psychiatry, Respiratory disease and allergy, Urology and nephrology

Adrenaline autoinjector supply disruption

In response to the ongoing supply disruption of adrenaline autoinjectors, MHRA has allowed an extension of the use of specific lot (batch) numbers of Jext 150 mcg and Jext 300 mcg auto-injectors beyond the labelled expiry date by 4 months. See letter to healthcare professionals and Jext website for list of affected batches.

Advise patients to continue to check periodically the viewing window in the label of their autoinjector to ensure that the liquid inside is clear and colourless and replace if the liquid is discoloured.

See also the updated Department of Health and Social Care supply disruption alert (issued 15 October 2018) and NHS England Pharmacy and Dispensing Practice Q&A for adrenaline autoinjectors.

Please note during this period of reduced supply, expert clinical guidance is to use 25 kg as the cut-off for switching from 150 mcg to 300 mcg dosage for all devices. For two of the devices (Jext and Emerade), this will be an off-label change.

Epanutin (phenytoin) 30mg/5ml oral suspension supply disruption

All healthcare professionals who prescribe, dispense or administer Epanutin oral suspension should be aware of the recommendations of the Department of Health and Social Care Supply Disruption Alert for Epanutin (phenytoin) 30mg/5ml oral suspension. Different formulations of phenytoin are not interchangeable and careful management of switching and monitoring is required.

MHRA has approved the import of stock phenytoin oral suspension from Canada. This stock is considered an unlicensed preparation in the UK. See alert for important advice for prescribers and pharmacists.

Letters

In October 2018, the following other letters were sent to healthcare professionals:

• Rivaroxaban (Xarelto▼): increase in all-cause mortality, thromboembolic and bleeding events in patients after transcatheter aortic valve replacement in a prematurely stopped clinical trial

• Ozurdex 700 micrograms intravitreal implant (dexamethasone): silicone particle observed on implant during inspection

• Sildenafil (Revatio and Viagra) should not be used to treat intrauterine growth restriction

• Hydrochlorothiazide: Risk of non‐melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma)

• Epilim Chronosphere▼ (sodium valproate) 250mg Modified Release Granules – Temporary shortage in supply until 30 November 2018

Drug alerts and recalls

In October 2018, MHRA issued the following Alerts and recalls for drugs:

• Class 2 Medicines Recall: Ozurdex 700 micrograms intravitreal implant in applicator manufactured by Allergan Pharmaceuticals Ireland (MDR 95-08/18). Issued 5 October 2018. Allergan Pharmaceuticals Ireland is recalling specific batches due to the possibility that a single loose silicone particle of approximately 300microns in diameter may become detached.

Article citation: Drug Safety Update volume 12, issue 4: November 2018: 5.

Published 14 November 2018