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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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We have simplified our medicine and device incident report systems by bringing them all under the Yellow Card Scheme.
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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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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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Continued monitoring of medicines with a black triangle status.
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A reminder to healthcare professionals to fill out Yellow Card reports.
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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. Every Yellow Card report counts, and a few minutes…
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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Any healthcare professional can submit a Yellow Card, including students. When submitting a report about a medicine via the Yellow Card website, if your occupation is not available in our drop-down list, you can now select ‘…
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Updated dosing for paediatric paracetamol liquids has been developed to ensure children receive the optimum dose for their age.
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We are no longer requesting all suspected adverse drug reactions (ADRs) to be reported for children.
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The Yellow Card App has been updated to make it easier to use, to have useful new features, and to support reporting a suspected reaction related to medicine exposure during pregnancy. Download the App today and let us know …
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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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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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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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Remember to report any suspected adverse reactions
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When children receiving replacement therapy for adrenal insufficiency are being switched from hydrocortisone tablets to Alkindi granules, parents or carers should be informed of the need to be extra vigilant for symptoms of …
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The ninth annual #MedSafetyWeek social media campaign is taking place 4 to 10 November 2024.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Pregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised respiratory function, respiratory …
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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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A summary of recent letters and notifications sent to healthcare professionals about medicines
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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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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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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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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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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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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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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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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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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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…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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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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How MHRA monitors the impact of regulatory action taken.
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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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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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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, medicine recalls and notifications sent to healthcare professionals
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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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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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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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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…