Letters and drug alerts sent to healthcare professionals in June 2020

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

• From: Medicines and Healthcare products Regulatory Agency
• Published: 31 July 2020
• Last updated: 31 July 2020 — See all updates

• Therapeutic area: Anaesthesia and intensive care, Endocrinology, diabetology and metabolism, Immunosuppression and transplantation, Nutrition and dietetics

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.

Lopinavir-ritonavir: RECOVERY trial finds no clinical benefit in COVID-19 Comparison of 1596 patients randomised to lopinavir-ritonavir with 3376 patients randomised to usual care found no significant difference in the primary endpoint of 28-day mortality. The trial arms for these medicines has subsequently closed.

Remdesivir for patients hospitalised with COVID-19 (adults and children of 12 years and older) An interim clinical commissioning policy to define routine access to remdesivir in the treatment of COVID-19 across the UK. This follows confirmation of a Conditional Marketing Authorisation (CMA) by the European Medicines Agency (EMA) for the use of remdesivir in the treatment of COVID-19 in adults and adolescents (aged 12 years and older with body weight at least 40 kg) with pneumonia requiring supplemental oxygen. The Early Access to Medicines Scheme (EAMS) put in place in May 2020 has now ended. See Summary of Product Characteristics for remdesivir.

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

Letters

Safety letters – June 2020

In June 2020, the following letters were sent or provided to relevant healthcare professionals related to safety procedures:

• Ondexxya: signal of erroneous assay results for levels of antifactor Xa activity with use of andexanet alfa

• 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe and fatal toxicity

• Flucytosine: Updated recommendations for the use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency

• Myalepta (metreleptin) 5.8 mg vial: inconsistency in the English-language package leaflet (PL)

• Viaflex Specials products containing sodium chloride, heparin sodium, potassium chloride and magnesium sulfate: incorrect information on the primary and secondary labels

• Brinzolamide 10mg/Timolol Maleate 5mg eye drops: omission of legal category of prescription only medicine (POM) on packaged cartons in the UK

Supply-related letters – June 2020

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

• Diprivan 10 mg/ml (1%) Emulsion for Injection or Infusion (propofol): Interim supply of Stock to Mitigate Supply Disruption

• Belvo 250 mg gastro-resistant tablets: extension of shelf life for two batches

• EpiPen (Adrenaline) Auto-Injector 0.3 mg: supply of a batch (no. 9FM766) with US-labelled auto-injectors packaged in UK cartons with a UK leaflet

• 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 blister foil

Drug alerts – June 2020

Class 2 Medicines Recall: Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles), EL (20)A/25. Issued 8 June 2020. Specific batches of Epistatus (Midazolam) 10mg/mL Oromucosal Solution (multi-dose bottles) are being recalled due to a potentially faulty and incorrectly engaged child-resistant container closure.

Class 4 Medicines Defect Information: Depo-Provera 150mg/mL Injection (1mL Vial) EL (20)A/26. Issued 30 June 2020. There is the typographical error in active ingredient stated on the label on the vial. The active ingredient should be “medroxyprogesterone acetate” (a long acting contraceptive) however, it is stated as “methylpredinisolone acetate” (a corticosteroid). The outer carton and leaflets (Patient leaflet and Healthcare Professional leaflet) list the correct active ingredient

Article citation: Drug Safety Update volume 13, issue 12: July 2020: 3.

Published 31 July 2020
Last updated 31 July 2020 + show all updates

1. 31 July 2020

   Republished in order to change the display order of articles; content unchanged

2. 31 July 2020

   First published.