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Second year safety review
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Following the completion of a safety review and the recommendations of the Commission on Human Medicines (CHM), the IXCHIQ Chikungunya vaccine is no longer indicated for adults over the age of 60 years, and is contraindicated in all individuals with hypertension, cardiovascular disease…
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…that people only receive the vaccine after a thorough risk assessment.…
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Monitoring for encephalitis should continue for 12 months following discontinuation of daclizumab. Inform all patients who have discontinued daclizumab and their caregivers of the common symptoms of encephalitis and the need to contact their doctor immediately if they occur.
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Further to our previous advice in 2016, Public Health England have updated their guidance about live vaccination of infants born to a mother who received immunosuppressive biological therapy during pregnancy.
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Letters were sent about daclizumab beta (Zinbryta▼), alteplase (Actilyse), Esmya (ulipristal acetate), and Xofigo▼ (radium-223-dichloride). MHRA issued alerts and recalls for batches of Nutriflex Omega Special 2500 ml and Nu…
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Healthcare professionals working in primary and secondary care should ensure that clinically significant immunosuppression in a patient is identified before administration of a live attenuated vaccine.
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…Fatal cases of encephalitis and meningitis caused by herpes simplex and varicella zoster viruses have also been reported during treatment. Advise patients to seek urgent medical attention if they develop any clinical features of liver dysfunction or meningoencephalitis.…
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There is a small increase in the risk of Guillain-Barré syndrome following vaccination with Abrysvo (Pfizer respiratory syncytial virus (RSV) vaccine) and Arexvy (GSK RSV vaccine) in adults aged 60 years and older.…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Updated dosing for paediatric paracetamol liquids has been developed to ensure children receive the optimum dose for their age.
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Report to the Yellow Card Scheme suspected adverse reactions associated with medicines taken during pregnancy experienced by women or the baby or child. Obstetricians and midwives have a particularly important role in provid…
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The European Medicines Agency (EMA) has recommended the immediate suspension of the marketing authorisation and recall of daclizumab (Zinbryta) in the EU following reports of serious inflammatory brain disorders, including encephalitis and meningoencephalitis, in patients with multiple…
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A large study has shown no safety issues of concern relating to the use of metformin during pregnancy. The licence for metformin now reflects that it can be considered for use during pregnancy and the periconceptional phase …
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We have recently received 2 reports of fatal adverse reactions to the yellow fever vaccine (Stamaril). Due to an increased risk of life-threatening reactions, the vaccine must not be given to anyone with a medical history of thymus dysfunction or who is immunosuppressed.…
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A standardised pre-vaccination checklist has been introduced to ensure the yellow fever vaccine is indicated for the intended travel destination and to enable vaccinators to identify existing contraindications or precautions in individuals before vaccination.
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…The IXCHIQ vaccine will be available on the UK market from 18 June 2025.
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Recent information relating to COVID-19 vaccines that has been published since the July 2021 issue of Drug Safety Update.
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…vaccination.…
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Healthcare professionals should advise patients who need re-vaccination with Pneumovax II to expect a more intense reaction than after their first vaccination.
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…This year’s theme is on the importance of reporting suspected adverse reactions to vaccines.…
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…7 January 2021 - Advice from the MHRA on the COVID-19 vaccines authorised for use in the UK, including advice for people with allergies and for women during pregnancy and breastfeeding.…
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Report of febrile promptly.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the March 2022 issue of Drug Safety Update, up to 14 April 2022.
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While an urgent EU-wide review of new information on liver safety is under way, promptly review patients on treatment. Only initiate daclizumab in restricted groups of patients with limited treatment options and keep all pat…
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Use alternative vaccines in under 5s and report suspected adverse reactions
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Recent information relating to COVID-19 vaccines and medicines that has been published since the February 2023 issue of Drug Safety Update, up to 21 March 2023.…
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Recent information relating to COVID-19 vaccines and medicines that has been published since the August 2022 issue of Drug Safety Update, up to 23 September 2022.
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No evidence of increased risk of febrile convulsions in children.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the April 2022 issue of Drug Safety Update, up to 13 May 2022.
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No unexpected new safety issues have been identified from Yellow Card reports.
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A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 11 June 2021.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the December 2022 issue of Drug Safety Update, up to 23 January 2022.
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Outline of the safety experience of these medicines in the UK from our proactive safety monitoring strategy.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the May 2022 issue of Drug Safety Update, up to 17 June 2022.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the January 2023 issue of Drug Safety Update, up to 21 February 2023.…
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A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 18 March 2021.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the September 2021 issue of Drug Safety Update, up to 1 October 2021.
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A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 16 February 2021.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the August 2021 issue of Drug Safety Update, up to 9 September 2021.
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…The non-identical nature of biological medicines and vaccines means it is very important that safety surveillance is carried out on a brand/product-specific basis.…
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Recent information relating to COVID-19 vaccines and medicines that has been published since the January 2022 issue of Drug Safety Update, up to 11 February 2022.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the July 2022 issue of Drug Safety Update, up to 19 August 2022.
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The human papillomavirus (HPV) immunisation programme is now entering its second year and this article summarises the safety experience to date.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the September 2022 issue of Drug Safety Update, up to 21 October 2022.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the November 2022 issue of Drug Safety Update, up to 8 December 2022.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the October 2022 issue of Drug Safety Update, up to 24 November 2022.…
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…Cervarix was replaced in the programme by the HPV vaccine Gardasil▼ from September 2012.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the December 2021 issue of Drug Safety Update, up to 13 January 2022.…
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A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 21 April 2021.