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A pooled analysis has shown an increased rate of new primary malignancies in patients given Xgeva (1-year cumulative incidence 1.1%) compared with those given zoledronic acid (0.6%), when used in the indication of the preven…
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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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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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Prescribing information has been updated to help to minimise the risk of serious adverse reactions in patients with cardiac disease.
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Implementation of measures to regulate sales, together with the additional voluntary actions overseen by the pharmacy profession, has made an important contribution to managing the risk of misuse of pseudoephedrine and ephed…
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How MHRA monitors the impact of regulatory action taken.
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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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MHRA has received a small number of reports suggesting lack of efficacy (thromboembolic events) in patients taking 15 mg or 20 mg rivaroxaban on an empty stomach; remind patients to take 15 mg or 20 mg rivaroxaban tablets wi…
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Guidance has been published on monitoring of patients on warfarin and other anticoagulants during the COVID-19 pandemic.
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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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Should not be used for cough under 18 years
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The Commission on Human Medicines recommend that existing levels of monitoring, education, and awareness measures by pharmacists should be maintained.
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Sales restrictions introduced in 2008 continue to be successful in managing the risk of misuse of pseudoephedrine and ephedrine.
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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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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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Medication errors and inappropriate use of the rivastigmine transdermal patch have been reported, some of which resulted in overdose. Healthcare professionals should be aware of the correct use of rivastigmine, and should ad…
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Emerging clinical trial evidence of increased cardiovascular risk.
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Calcitonin-containing medicines should no longer be used in treatment of osteoporosis.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Use only when other antibiotics are unsuitable
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Rare cases of atypical femoral fracture with long-term use.
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Take particular care when prescribing or dispensing medicines that could be confused with others (ie, they sound-alike or look-alike).
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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 heal…
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Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with these medicines. All patients should be tested for DPD deficiency be…
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A summary of recent letters and notifications sent to healthcare professionals about medicines, and a recent National Patient Safety Alert highlighting the risk of deaths and serious injuries from entrapment or falls relatin…
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Gabapentin has been associated with a rare risk of severe respiratory depression even without concomitant opioid medicines. Patients with compromised respiratory function, respiratory or neurological disease, renal impairmen…
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Mixing drugs together, where one is not a vehicle for the administration of the other, creates an unlicensed medicine.
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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…
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Healthcare professionals should be vigilant for suspected adverse reactions and safety concerns associated with e-cigarettes and e-liquids, commonly known as vapes. Please report adverse reactions to the Yellow Card scheme a…
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You should take caution when you use NSAIDs in patients with renal impairment or are at risk.
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Healthcare professionals should consider measuring magnesium levels before starting PPI treatment and repeat measurements periodically during prolonged treatment.
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If new movement disorders occur during treatment consider dose reduction or a gradual discontinuation of treatment in consultation with specialist advice.
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New advice to minimise risk
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A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 16 February 2021.
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Healthcare professionals should be aware of the updated information so they can discuss it with new and existing patients.
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Use alternative vaccines in under 5s and report suspected adverse reactions
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Risk of early psychiatric side-effects is one of several important safety issues for healthcare professionals to discuss with patients and carers, who should seek urgent medical advice in the event of any worrying symptoms.
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Central serous chorioretinopathy is a retinal disorder that has been linked to the systemic use of corticosteroids. Recently, it has also been reported after local administration of corticosteroids via inhaled and intranasal…
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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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Fingolimod is associated with an increased risk of major congenital malformations including cardiac, renal, and musculoskeletal defects, when used in pregnancy. Women of childbearing potential must use effective contraceptio…
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Some batches of gentamicin sulphate active pharmaceutical ingredient (API) used to manufacture gentamicin may contain higher than expected levels of histamine, which is a residual from the manufacturing process. Monitor pati…
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Letters were sent about Vyxeos (cytarabine, daunorubicin) and Ozurdex 700 micrograms intravitreal implant (dexamethasone). Alerts were issued about irbesartan, amoxicillin, atropine sulfate, and paracetamol infusion.
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Risk of thrombosis and haemorrhage in patients with prosthetic heart valve(s) requiring anti-coagulant treatment.
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Monitor patients closely and remove the vaginal delivery system immediately in cases of excessive or prolonged uterine contractions, at the onset of labour, or if there is clinical concern for mother or baby.
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Cases of benign and malignant neoplasms have been observed among children and adolescents who received treatment with mecasermin. Do not use mecasermin in children or adolescents with active or suspected neoplasia or with an…
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Supporting safer use
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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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Reports of acquired haemophilia have been received in association with clopidogrel.
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Be especially alert for adverse drug reactions (ADRs) in patients taking more than one medicine and report any suspected ADRs to the Yellow Card Scheme. Show your support for the MHRA’s ADR awareness week campaign on 17–23 F…