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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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The authorisation holder for dapagliflozin has withdrawn the indication for type 1 diabetes mellitus.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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Oral diclofenac is associated with a small increased risk of cardiovascular side effects and is therefore no longer available over the counter.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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There is a risk of harmful drug interactions with the ritonavir component of the COVID-19 treatment Paxlovid▼ due to its inhibition of the enzyme CYP3A, which metabolises many commonly used drugs. Prescribers should obtain a…
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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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Healthcare professionals are encouraged to report all suspected adverse reactions (ADRs) on the yellow card porftal to melt formulations of desmopressin.
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Reporting to the new site will enable the MHRA to rapidly identify new and emerging side effects and medical device incidents in COVID-19 treatment, including side effects for medicines taken by patients to manage long-term …
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices
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On 14 July 2015, the Yellow Card mobile app was launched - use it to report suspected reactions and receive up to date information on your medicines of interest.
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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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…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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If a patient reports persistent symptoms when switching between different levothyroxine tablet formulations, consider consistently prescribing a specific product known to be well tolerated by the patient. If symptoms or poor…
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The monitoring requirements and discontinuation criteria for dimethyl fumarate (Tecfidera) have been strengthened following a small number of reports of progressive multifocal leukoencephalopathy (PML) in patients with mild …
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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…
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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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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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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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Cases of severe cutaneous adverse reactions, including Stevens-Johnsons syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients treated with immune-stimulatory anti-cancer drugs, including atezoli…
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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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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
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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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Confidential reports designed to help you improve the quality of your prescribing and patient safety are now available for practices that contribute to the MHRA’s Clinical Practice Research Datalink.
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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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You can use our free e-learning modules to find out more about how and when to report suspected adverse drug reactions and earn CPD credits at the same time.
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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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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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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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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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A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.
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We are running a second social media campaign to promote the reporting of suspected adverse drug reactions (ADRs) to the Yellow Card Scheme in support of the ADR awareness week taking place 20-24 November 2017. The main mess…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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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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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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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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Risks such as toxin spread reported mostly with off-label use.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Letters were sent on Typhim Vi vaccines, Mepact (mifamurtide), and Xeljanz (tofacitinib) and an alert issued to recall Emerade 150 microgram adrenaline pens.…
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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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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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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The annual #MedSafetyWeek campaign takes place from 3 to 9 November 2025. This year’s campaign theme is ‘we can all help make medicines safer.’
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A review of the risks of major congenital malformations and of adverse neurodevelopmental outcomes for antiepileptic drugs by the Commission on Human Medicines has confirmed that lamotrigine (Lamictal) and levetiracetam (Kep…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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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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Remain vigilant for suspected adverse drug reactions and report them to the Yellow Card scheme. Show your support during #MedSafetyWeek on 2–8 November 2020 by sharing material on social media and discussing with colleagues …
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages.
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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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Following receipt of a third case of fatal medication error caused by the administration of Fungizone (a non-lipid-based formulation of amphotericin B) instead of a lipid-based formulation (AmBisome, Abelcet), we remind healthcare professionals that these formulations are not interchangeable…