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Direct-acting oral anticoagulants (DOACs): paediatric formulations; reminder of dose adjustments in patients with renal impairment
Risk minimisation materials are available to support the safe use of new paediatric formulations of rivaroxaban (Xarelto) and dabigatran etexilate (Pradaxa). In addition, we ask healthcare professionals to consult the curren…
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Glucose solutions: recommendations to minimise the risks associated with the accidental use of glucose solutions instead of saline solutions in arterial lines
We remind healthcare professionals that accidental use of glucose-containing solutions as flush fluid for arterial lines may contaminate blood samples and result in falsely high glucose readings. This may lead to inappropria…
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Febuxostat: updated advice for the treatment of patients with a history of major cardiovascular disease
Caution is required if prescribing febuxostat in patients with pre-existing major cardiovascular disease, particularly, in those with evidence of high urate crystal and tophi burden or those initiating urate-lowering therapy…
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Letters and medicine recalls sent to healthcare professionals in April 2023
Recent MHRA National Patient Safety Alerts to remove from service Philips Health Systems V60 and V60 Plus ventilators and to recall Emerade adrenaline auto-injectors from patients, pharmacies and wholesalers. We also provide…
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Isotretinoin (Roaccutane▼): new safety measures to be introduced in the coming months, including additional oversight on initiation of treatment for patients under 18 years
The Isotretinoin Expert Working Group of the Commission on Human Medicines has made recommendations to strengthen the safety of isotretinoin treatment. Recommendations include new warnings, the need for consistent monitoring…
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Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
We inform healthcare professionals of new risk minimisation measures for JAK inhibitors used to treat chronic inflammatory disorders, consistent with the measures introduced for tofacitinib (Xeljanz) in 2020 and 2021. This a…
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Nitrofurantoin: reminder of the risks of pulmonary and hepatic adverse drug reactions
Healthcare professionals prescribing nitrofurantoin should be alert to the risks of pulmonary and hepatic adverse drug reactions and advise patients to be vigilant for the signs and symptoms in need of further investigation.
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Letters and medicine recalls sent to healthcare professionals in March 2023
A summary of recent letters and notifications sent to healthcare professionals about medicines.
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Pholcodine-containing cough and cold medicines: withdrawal from UK market as a precautionary measure
Advice for healthcare professionals regarding the withdrawal of pholcodine-containing medicines from the market.
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Terlipressin: new recommendations to reduce risks of respiratory failure and septic shock in patients with type 1 hepatorenal syndrome
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…
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COVID-19 vaccines and medicines: updates for March 2023
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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Letters and medicine recalls sent to healthcare professionals in February 2023
A summary of recent letters and notifications sent to healthcare professionals about medicines.
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COVID-19 vaccines and medicines: updates for February 2023
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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Letters and medicine recalls sent to healthcare professionals in January 2023
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Xaqua (metolazone) 5mg tablets: exercise caution when switching patients between metolazone preparations
Prescribers and dispensers should use caution if switching patients between different metolazone preparations as the rate and extent of absorption of metolazone are formulation dependent. This can impact the bioavailability …
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Topical testosterone (Testogel): risk of harm to children following accidental exposure
Premature puberty and genital enlargement have been reported in children who were in close physical contact with an adult using topical testosterone and who were repeatedly accidentally exposed to this medicine. To reduce th…
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Electronic Prescribing and Medicines Administration Systems: report adverse incidents on a Yellow Card
We ask healthcare professionals to be vigilant to adverse incidents involving software, apps, and artificial intelligence (AI) as medical devices and to report incidents to us via the Yellow Card scheme.
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COVID-19 vaccines and medicines: updates for January 2023
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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Letters and medicine recalls sent to healthcare professionals in December 2022
A summary of recent letters and notifications sent to healthcare professionals about medicines.
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Valproate: reminder of current Pregnancy Prevention Programme requirements; information on new safety measures to be introduced in the coming months
In view of data showing ongoing exposure to valproate in pregnancy, this article reminds healthcare professionals of the risks in pregnancy and the current Pregnancy Prevention Programme requirements, and provides informatio…
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COVID-19 vaccines and medicines: updates for December 2022
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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Letters and medicine recalls sent to healthcare professionals in November 2022
A summary of recent letters and notifications sent to healthcare professionals about medicines.
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Dupilumab (Dupixent▼): risk of ocular adverse reactions and need for prompt management
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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Consultation with healthcare professionals: please complete our consultation to help influence how we communicate with you
The MHRA is reviewing its approach to engaging with healthcare professionals on the safety of medicines and medical devices. Through our consultation, you can provide your views and help inform our new approach.
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COVID-19 vaccines and medicines: updates for November 2022
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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Letters and medicine recalls sent to healthcare professionals in October 2022
A summary of recent letters and notifications sent to healthcare professionals about medicines.
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MedSafetyWeek November 2022: Every Yellow Card report helps to improve patient safety
The seventh annual #MedSafetyWeek social media campaign will take place 7 to 13 November 2022 and this year’s focus is the importance of reporting suspected adverse reactions to medicines and vaccines. We are also encouragin…
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COVID-19 vaccines and medicines: updates for October 2022
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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Letters and medicine recalls sent to healthcare professionals in September 2022
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Methylphenidate long-acting (modified-release) preparations: caution if switching between products due to differences in formulations
Prescribers and dispensers should use caution if switching patients between different long-acting formulations of methylphenidate (Concerta XL, Medikinet XL, Equasym XL, Ritalin LA, and generics) as different instructions fo…
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Rucaparib (Rubraca▼): withdrawal of third-line treatment indication
The third-line treatment indication for rucaparib has been withdrawn following a review of the findings of the ARIEL-4 trial, which showed lower overall survival for rucaparib treatment versus standard chemotherapy in patien…
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COVID-19 vaccines and medicines: updates for September 2022
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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Letters and medicine recalls sent to healthcare professionals in August 2022
A summary of recent letters and notifications sent to healthcare professionals about medicines
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Nebulised asthma rescue therapy in children: home use of nebulisers in paediatric asthma should be initiated and managed only by specialists
Use of a nebuliser purchased independently of medical advice for use in the home to deliver nebulised asthma rescue medications to children can mask a deterioration in the underlying disease and may increase the risk of pote…
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COVID-19 vaccines and medicines: updates for August 2022
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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Letters and medicine recalls sent to healthcare professionals in July 2022
A summary of recent letters and notifications sent to healthcare professionals about medicines, and a patient safety alert on mexiletine hydrochloride.
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Topiramate (Topamax): start of safety review triggered by a study reporting an increased risk of neurodevelopmental disabilities in children with prenatal exposure
We have initiated a new safety review into topiramate as a result of an observational study reporting an increased risk of neurodevelopmental disabilities in children whose mothers took topiramate during pregnancy.
Topir…
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COVID-19 vaccines and medicines: updates for July 2022
Recent information relating to COVID-19 vaccines and medicines that has been published since the June 2022 issue of Drug Safety Update, up to 20 July 2022.
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Letters and medicine recalls sent to healthcare professionals in June 2022
A summary of recent letters and notifications sent to healthcare professionals about medicines.
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Metformin and reduced vitamin B12 levels: new advice for monitoring patients at risk
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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Roche Accu-Chek Insight insulin pump with NovoRapid PumpCart insulin cartridges: alert following cases of insulin leakage
We have issued a National Patient Safety Alert following serious reports of harm associated with insulin leakage during use of the Accu-Chek Insight Insulin pump with NovoRapid PumpCart prefilled insulin cartridges. Patients…
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COVID-19 vaccines and medicines: updates for June 2022
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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Letters and medicine recalls sent to healthcare professionals in May 2022
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices
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Denosumab 60mg (Prolia): should not be used in patients under 18 years due to the risk of serious hypercalcaemia
Serious and life-threatening hypercalcaemia has been reported with denosumab 60mg (Prolia) in children and adolescents in clinical trials for osteogenesis imperfecta and during off-label use. Denosumab 60mg (Prolia) is autho…
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COVID-19 vaccines and medicines: updates for May 2022
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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Letters and medicine recalls sent to healthcare professionals in April 2022
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. Includes a recent recall of Accupro (quinapril hydrochloride) and advice on Xagrid (anagrelide hydrochloride…
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Pregabalin (Lyrica): findings of safety study on risks during pregnancy
A new study has suggested pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. Patients should continue to use effective contraception during treatment and avoid use in pregnancy …
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COVID-19 vaccines and medicines: updates for April 2022
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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Letters and medicine recalls sent to healthcare professionals in March 2022
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. Includes a recent recall of Accuretic (quinapril hydrochloride and hydrochlorothiazide).
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Cladribine (Mavenclad): new advice to minimise risk of serious liver injury
Liver monitoring requirements for cladribine in the treatment of multiple sclerosis have been introduced following uncommon cases of serious liver injury. Advise patients to seek urgent medical attention if they develop any …