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Use alternative vaccines in under 5s and report suspected adverse reactions
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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How MHRA monitors the impact of regulatory action taken.
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Letters were sent about quadrivalent influenza vaccine, fentanyl ampoules, and Volibris (ambrisentan), and a number of pharmacy-level recalls were issued for ranitidine-containing products. Other alerts issued in October 2019 are also summarised in this article.…
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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We inform healthcare professionals that the Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. This new guidanc…
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Rarely, severe adverse effects can occur on stopping treatment with topical corticosteroids, often after long-term continuous or inappropriate use of moderate to high potency products. To reduce the risks of these events, pr…
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Periodically perform skin examinations in patients on bendamustine-containing regimens and consider PML in the differential diagnosis for patients on bendamustine with new or worsening neurological, cognitive, or behavioural…
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Healthcare professionals prescribing dupilumab should be alert to the risks of ocular reactions. New onset or worsening ocular symptoms require prompt review. Referral for ophthalmological examination should be made as appro…
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No evidence of increased risk of febrile convulsions in children.
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Report of febrile promptly.
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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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…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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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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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and a recent National Patient Safety Alert asking organisations to put a plan in place to implement new regu…
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…Letters were also sent about quadrivalent influenza vaccines and systemic and inhaled fluoroquinolones and an alert was issued about Mitomycin-C Kyowa.…
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Healthcare professionals should advise patients and/or carers of the changes in the dose, packaging, dose dispenser and leaflet.
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Letters were sent to healthcare professionals about Lartruvo▼ (olaratumab), quadrivalent influenza vaccine (split virion, inactivated), SGLT2 inhibitors, and carbimazole and thiamazole (synonym: methimazole)-containing products.…
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
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Liver monitoring requirements and discontinuation criteria for fingolimod have been updated following reports of serious liver injury. Fatal cases of encephalitis and meningitis caused by herpes simplex and varicella zoster …
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Decreased vitamin B12 levels, or vitamin B12 deficiency, is now considered to be a common side effect in patients on metformin treatment, especially in those receiving a higher dose or longer treatment duration and in those …
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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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…that people only receive the vaccine after a thorough risk assessment.…
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…The IXCHIQ vaccine will be available on the UK market from 18 June 2025.
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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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Second year safety review
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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 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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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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New recommendations following a recent clinical trial which found that in patients with type 1 hepatorenal syndrome terlipressin may cause serious or fatal respiratory failure at a frequency higher than previously known, and that terlipressin increases the risk of sepsis and septic shock…
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…In addition, extreme caution must be used and a careful risk assessment conducted before vaccination of people aged 60 years and older due to a substantially increased risk of such adverse reactions in this age group.…
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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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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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…Patients who are co-infected with hepatitis B and C viruses are at risk of hepatitis B reactivation, and should be monitored and managed according to current clinical guidelines.
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…This year’s theme is on the importance of reporting suspected adverse reactions to vaccines.…
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Risks such as toxin spread reported mostly with off-label use.
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2018 saw a fall in reporting of suspected adverse drug reactions (ADRs) to the Yellow Card Scheme from key reporter groups, including GPs, pharmacists, and hospital doctors.…
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Albumin-bound paclitaxel formulations for infusion (nab-paclitaxel; brand names Abraxane, Pazenir) differ from conventional paclitaxel medicines in their authorised indications, pharmacokinetics, recommended dosages, and pre…
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The authorisation holder for dapagliflozin has withdrawn the indication for type 1 diabetes mellitus. The removal of the type 1 diabetes indication is not due to any new safety concerns and the other indications of dapagliflozin are unchanged.
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Amiodarone has been associated with serious and potentially life-threatening side effects, particularly of the lung, liver, and thyroid gland. We remind healthcare professionals that patients should be supervised and reviewe…
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Cases of serious liver injury with elevated transaminases and bilirubin have been reported during treatment with Kaftrio–Kalydeco combination therapy. In all patients, measure alanine aminotransferase (ALT), aspartate aminot…
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The eighth annual #MedSafetyWeek social media campaign will take place from 6 to 12 November 2023. It will focus on the importance of reporting suspected adverse reactions to medicines and suspected problems with medical dev…
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If patients are known to be HLA-B*1502-positive, phenytoinshould be avoided when alternative therapy can be given.
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Information on the newly launched Safer Medicines in Pregnancy and Breastfeeding Consortium and a new report on optimising data on medicines used during pregnancy.
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We have published guidance about the use of remote consultations for pregnancy prevention in women of childbearing potential and monitoring for signs of psychiatric reactions (especially depression) and other safety risks in…
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SSRIs and SNRIs are known to increase bleeding risks due to their effect on platelet function. Data from observational studies suggest that the use of SSRI/SNRI antidepressants during the month before delivery may result in …
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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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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Key MHRA advice and guidance issued so far on medicines safety and pharmacovigilance, including on reporting to the Yellow Card Scheme.
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Cases of interstitial lung disease and pneumonitis have been reported in patients receiving CDK4/6 inhibitors indicated for some breast cancers. Ensure that patients taking these medicines are aware of the need to seek advic…