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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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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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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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Make a clear distinction between liposomal, pegylated-liposomal, lipid-complex and conventional formulations when prescribing, dispensing, administering, and communicating about these medicines. Medicines with these formulat…
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Before starting treatment with pomalidomide, establish hepatitis B virus status in all patients.…
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A summary of letters and drug alerts recently sent to healthcare professionals.
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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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Be vigilant for any suspected adverse reactions associated with use of e-cigarettes or vaping (including lung injury) and report them to the MHRA via the Yellow Card scheme. In this article we provide UK case definitions of …
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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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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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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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Evidence suggests an increased risk of aminoglycoside-associated ototoxicity in patients with mitochondrial mutations, including cases in which the patient’s aminoglycoside serum levels were within the recommended range. The…
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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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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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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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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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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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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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Patients should be tested for hepatitis B virus before starting treatment with BCR-ABL tyrosine kinase inhibitors.
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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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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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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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The indication of ulipristal acetate 5mg for uterine fibroids has been further restricted due to the risk of serious liver injury and liver failure, with some cases requiring liver transplantation. Although the temporary sus…
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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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Cutaneous amyloidosis at the injection site has been reported in patients using insulin and this may affect glycaemic control. Remind patients to rotate injection sites within the same body region.
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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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Test liver function before and during treatment and tell patients to avoid sunlight exposure.
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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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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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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Screening for hepatitis B virus is now recommended in all patients (not only those at risk of this infection) before starting treatment for all indications.
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Patients with active infection with this virus should not be treated with ofatumumab.
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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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Healthcare professionals should be aware of epidemiological data showing a small increased risk of fractures associated with the use of TCAs and SSRIs, and should take this risk into account in their discussions with patient…
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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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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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importance of establishing wild type RAS (KRAS and NRAS) status before treatment of metastatic colorectal cancer
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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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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.