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Repeat enhanced cardiovascular monitoring when restarting fingolimod after treatment interruption,
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Following a review of the risks associated with use of opioid medicines for non-cancer pain, the Commission on Human Medicines (CHM) has recommended that fentanyl transdermal patches are contraindicated in opioid-naive patie…
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Provide clear information to patients and caregivers about how to minimise the risk of accidental exposure and the importance of appropriate disposal of patches. We continue to receive reports of unintentional opioid toxicit…
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Do not use in children aged 16 years or less, except in specialist settings under expert medical supervision.
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Proton pump inhibitors (PPIs) are associated with very infrequent cases of subacute cutaneous lupus erythematosus (SCLE), a non-scarring dermatosis that can develop in sun-exposed areas.
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Before prescribing hormone-replacement therapy, healthcare professionals should consider carefully the potential benefits and risks for every woman
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Reminder to monitor and manage weight, glucose, and lipid levels.
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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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Mycophenolate mofetil and its active metabolite mycophenolic acid are associated with a high rate of serious birth defects and increased risk of spontaneous abortion.
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Advise patients treated with ingenol mebutate gel to be vigilant for new skin lesions and to seek medical advice immediately should any occur. Use with caution in patients with a history of skin cancer.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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A review has found that low levels of gadolinium can be retained in the brain and other tissues after administration of gadolinium-containing contrast agents (GdCAs). There is currently no evidence that gadolinium deposition…
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The design and content of the Patient Information Leaflets for methylphenidate products are being updated with the latest guidance on safe and effective use for patients and carers
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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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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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Recent epidemiological studies suggest exposure to ondansetron during the first trimester of pregnancy is associated with a small increased risk of the baby having a cleft lip and/or cleft palate.
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Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hall…
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Minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia.
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Evaluate a patient’s individual factors for benefits and risks before initiating treatment with denosumab 60mg, particularly in those with previous vertebral fracture. Patients should not stop denosumab without specialist re…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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We remind healthcare professionals that isotretinoin should only be used for severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. Prescription of isotretino…
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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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The product information for all Glucagon-Like Peptide-1 (GLP-1) receptor agonists and dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists has been further updated to highlight the potential risk o…
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If bilirubin and/or creatinine test results are inconsistent with clinical observations, request re-testing using another method to determine the validity of the result.
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Several new high strength insulin products are now on the market. The European Medicines Agency is consulting on guidance to minimise the risk of medication error.
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The Commission on Human Medicines (CHM) has temporarily restricted use of the IXCHIQ Chikungunya vaccine in people aged 65 years and over following very rare fatal reactions reported globally. This is a precautionary measure…
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Avoid treatment with febuxostat in patients with pre-existing major cardiovascular disease (for example, myocardial infarction, stroke, or unstable angina), unless no other therapy options are appropriate. Findings from a ph…
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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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With the exception of medicines containing zidovudine, stavudine, or didanosine, product information will no longer include warnings on fat redistribution or lactic acidosis.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices
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Administration of parenteral nutrition without a filter has been associated with a number of adverse incidents including an embolism which resulted in a fatal outcome.
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Patients should be reminded and reassured that there is no evidence that taking paracetamol during pregnancy causes autism in children. Paracetamol is recommended as the first-choice pain reliever for pregnant women, used at…
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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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Modafinil potentially increases the risk of congenital malformations when used in pregnancy. Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment…
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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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Before initiating systemic vascular endothelial growth factor (VEGF) pathway inhibitors, carefully consider the risk of aneurysm and artery dissection in patients with risk factors. In patients who receive a systemic VEGF pa…
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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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Updated safety and educational materials are now available to support the implementation of the regulatory measures announced in the November 2023 National Patient Safety Alert and the September 2024 Drug Safety Update. They…
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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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More than one treatment course is authorised only in women who are not eligible for surgery, and liver function monitoring is to be carried out in all women treated with Esmya. Before initiation, discuss with women the rare …
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The maximum recommended dose for simvastatin in conjunction with amlodipine and diltiazem is now 20 mg/day.
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Risk of meningioma with cyproterone acetate increases with increasing cumulative dose. Use of cyproterone is contraindicated in patients with previous or current meningioma (for all indications) and should only be considered…
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The Commission on Human Medicines has issued a series of recommendations to strengthen measures to minimise risk with the yellow fever vaccine (Stamaril) following very rare fatal reactions. Key recommendations include new a…
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Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be measured before starting treatment with tocilizumab and monitored every 4–8 weeks for the first 6 months of treatment followed by every 12 …
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Healthcare professionals and patients are reminded of the risk of severe asthma attacks and increased mortality associated with overuse of SABA with or without anti-inflammatory maintenance therapy in patients with asthma. H…
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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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Remain vigilant for signs and symptoms of bleeding complications during treatment with DOACs (apixaban, dabigatran, edoxaban, rivaroxaban), especially in patients with increased bleeding risks. Specific reversal agents are a…
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The indication for the treatment of post-operative pain has been removed from the licences of all prolonged release opioids due to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilat…
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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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Risk minimisation materials are available to support the safe use of new paediatric formulations of rivaroxaban (Xarelto) and dabigatran etexilate (Pradaxa). In addition, we ask healthcare professionals to consult the curren…