Letters and drug alerts sent to healthcare professionals in June 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
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.
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.
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 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 .
Use the to report suspected side effects in COVID-19 treatment. See Drug Safety Update article from May 2020 for details.
Letters
Safety letters 鈥� June 2020
In June 2020, the following letters were sent or provided to relevant healthcare professionals related to safety procedures:
Supply-related letters 鈥� 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:
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Adoport (tacrolimus) 2mg capsules: limited number of packs with , , , and blister foil
Drug alerts 鈥� 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 鈥渕edroxyprogesterone acetate鈥� (a long acting contraceptive) however, it is stated as 鈥渕ethylpredinisolone acetate鈥� (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.