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.
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 and 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 (issued 15 October 2018) and 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 . 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 for important advice for prescribers and pharmacists.
Letters
In October 2018, the following other letters were sent to healthcare professionals:
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Rivaroxaban (Xarelto鈻�):
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Ozurdex 700 micrograms intravitreal implant (dexamethasone):
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Sildenafil (Revatio and Viagra)
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Hydrochlorothiazide:
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Epilim Chronosphere鈻� (sodium valproate) 250mg Modified Release Granules 鈥�
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.