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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 …
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Amiodarone (Cordarone X): reminder of risks of treatment and need for patient monitoring and supervision
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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Metformin in pregnancy: study shows no safety concerns
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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COVID-19 vaccines and medicines: updates for March 2022
Recent information relating to COVID-19 vaccines and medicines that has been published since the February 2022 issue of Drug Safety Update, up to 11 March 2022
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Letters and medicine recalls sent to healthcare professionals in February 2022
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
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COVID-19 antivirals: reporting to the UK COVID-19 Antivirals Pregnancy Registry
As the safety of COVID-19 antivirals in pregnancy has not been established, please report any pregnancies which occur during use of an antiviral, including paternal use, to the UK COVID-19 Antivirals Pregnancy Registry. This…
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Hydroxychloroquine, chloroquine: increased risk of cardiovascular events when used with macrolide antibiotics; reminder of psychiatric reactions
Carefully consider the benefits and risks before prescribing systemic azithromycin or other systemic macrolide antibiotics (erythromycin or clarithromycin) to patients being treated with hydroxychloroquine or chloroquine. An…
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Ivacaftor, tezacaftor, elexacaftor (Kaftrio▼) in combination with ivacaftor (Kalydeco): risk of serious liver injury; updated advice on liver function testing
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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COVID-19 vaccines and medicines: updates for February 2022
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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Letters and medicine recalls sent to healthcare professionals in January 2022
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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Brolucizumab (Beovu▼): risk of intraocular inflammation and retinal vascular occlusion increased with short dosing intervals
Maintenance doses of brolucizumab (after the first 3 doses) should not be given at intervals of less than 8 weeks apart.
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Paclitaxel formulations (conventional and nab-paclitaxel): caution required due to potential for medication error
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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COVID-19 vaccines and medicines: updates for January 2022
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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Letters and medicine recalls sent to healthcare professionals in December 2021
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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Haloperidol (Haldol): reminder of risks when used in elderly patients for the acute treatment of delirium
We remind healthcare professionals that elderly patients are at an increased risk of adverse neurological and cardiac effects when being treated with haloperidol for delirium. The lowest possible dose of haloperidol should b…
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Venetoclax (Venclyxto▼): updated recommendations on tumour lysis syndrome (TLS)
Fatal cases of tumour lysis syndrome (TLS) have been reported, some occurring in patients with chronic lymphocytic leukaemia receiving the lowest venetoclax dose used in the dose-titration schedule. For all patients, it is i…
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Dapagliflozin (Forxiga): no longer authorised for treatment of type 1 diabetes mellitus
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 dapaglifl…
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COVID-19 vaccines and medicines: updates for December 2021
Recent information relating to COVID-19 vaccines and medicines that has been published since the November 2021 issue of Drug Safety Update, up to 3 December 2021.
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Letters and medicine recalls sent to healthcare professionals in November 2021
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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Yellow fever vaccine (Stamaril): new pre-vaccination checklist
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…
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Adrenaline auto-injectors: reminder for prescribers to support safe and effective use
Emerade 300 and 500 microgram adrenaline auto-injectors have been re-supplied to the market following the implementation of corrective actions – patients and their caregivers should be provided with training and advice speci…
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COVID-19 vaccines and medicines: updates for November 2021
Recent information relating to COVID-19 vaccines and medicines that has been published since the October 2021 issue of Drug Safety Update, up to 12 November 2021.
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Letters and medicine recalls sent to healthcare professionals in October 2021
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies
Tofacitinib should not be used in patients older than 65 years of age, people who are current or past smokers, or individuals with other cardiovascular (such as diabetes or coronary artery disease) or malignancy risk factors…
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Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication
The paediatric indication for chloral hydrate (for children aged 2 years and older) and cloral (previously chloral) betaine (children aged 12 years and older) has been restricted to short-term treatment (maximum 2 weeks) of …
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MedSafetyWeek November 2021: support the safety of vaccines
Our sixth annual #MedSafetyWeek social media campaign will take place on 1 to 7 November 2021. This year’s theme is on the importance of reporting suspected adverse reactions to vaccines.
Show your support by sharing MHRA …
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COVID-19 vaccines: updates for October 2021
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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Letters and medicine recalls sent to healthcare professionals in September 2021
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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Topical corticosteroids: information on the risk of topical steroid withdrawal reactions
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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COVID-19 vaccines and medicines: updates for September 2021
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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Letters and medicine recalls sent to healthcare professionals in August 2021
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
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COVID-19 vaccines: updates for August 2021
Recent information relating to COVID-19 vaccines that has been published since the July 2021 issue of Drug Safety Update.
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Letters and medicine recalls sent to healthcare professionals in July 2021
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
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Chloramphenicol eye drops containing borax or boric acid buffers: use in children younger than 2 years
Following a review of the available toxicological data and a calculation of daily exposure to boron from a typical dosing regimen, we have concluded that the balance between the benefits and risks of chloramphenicol eye drop…
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Herbal and homeopathic medicines: reminder to be vigilant for suspected adverse reactions and to report them to the Yellow Card scheme
If an adverse drug reaction is suspected, ask patients if they are taking any herbal or homeopathic medicines and report any suspicions to the Yellow Card scheme. Remind patients to check that a herbal or homeopathic medicin…
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Oral retinoid medicines (isotretinoin▼, alitretinoin▼, and acitretin▼): temporary monitoring advice during coronavirus (COVID-19) pandemic
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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COVID-19 vaccines: updates for July 2021
Revisions have been made to the information for healthcare professionals and information for UK vaccine recipients for the COVID-19 Vaccine Moderna and Pfizer/BioNTech COVID-19 vaccine following a thorough review of ext…