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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Latest evidence suggests long-term use of combined oral contraceptives or progestogen-only injectable contraceptives is associated with a small increased risk of cervical cancer.
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Increased risk of arterial thromboembolism, including myocardial infarction and cerebrovascular events for patients treated with thalidomide.
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Second year safety review
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Monitor serum phosphate levels in patients treated with multiple high-dose administrations, or those on long-term treatment, and in those with pre-existing risk factors for hypophosphataemia. Re-evaluate ferric carboxymaltos…
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Patients on ipilimumab who present with diarrhoea or other symptoms of colitis, and those who do not respond to steroid treatment for immune-related colitis, should be investigated to exclude other causes, including infectio…
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A patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after trea…
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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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Insufficient evidence to confirm a link between oral bisphosphonate use and an increased risk of oesophageal cancer.
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Alerts were issued about CME T34 and T34L (T60) ambulatory syringe pumps, Cardinal Health tympanic thermometers, t:slim X2 insulin pump, and Mavidon skin preparation electrode gels.
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Use of has led to serious paracetamol overdose in a 6-month-old infant.
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Levonorgestrel-releasing intrauterine systems should always be prescribed by brand name because products have different indications, durations of use, and introducers.
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Healthcare professionals prescribing aripiprazole are reminded to be alert to the risk of addictive gambling and other impulse control disorders. Healthcare professionals should advise patients, their families and friends to…
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
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Some patients may have exacerbation or rebound symptoms of rosacea. It is important to initiate treatment with a small amount of gel and increase the dose gradually, based on tolerability and treatment response.
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While an urgent EU safety review evaluates reports of serious cardiovascular events and immune-mediated reactions, including autoimmune hepatitis, the use of alemtuzumab (Lemtrada) has been restricted and strengthened requir…
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Anti-cancer therapy with carfilzomib has been associated with cases of cardiac arrest, cardiac failure, and myocardial infarction, including in patients without pre-existing cardiac disorders. Monitor patients for signs and …
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Reports of reconstituted solution leaking from some models of extension sets and pumps.
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Report of febrile promptly.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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New clinical trial information is available on the timing of the loading dose of prasugrel when used in patients with unstable angina or non-ST segment elevation myocardial infarction.
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Risk of insufficient cortisol absorption and life-threatening adrenal crisis if muco-adhesive buccal tablets are used as adrenal replacement therapy.
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New advice for extended early monitoring for those with significant bradycardia or heart block after first dose.
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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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Statins (HMG-CoA reductase inhibitors) are widely used medicines for patients with lipid disorders and in the primary and secondary prevention of heart attack and stroke.
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A summary of recent letters and notifications sent to healthcare professionals about medicines
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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All products to be named and prescribed as caffeine citrate.
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Osteonecrosis of the external auditory canal has been reported very rarely (fewer than 1 in 10 000 patients) with bisphosphonates, mainly in association with long-term therapy (2 years or longer).
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Letters were sent about alemtuzumab (Lemtrada), Selenase (sodium selenite pentahydrate), and Erelzi▼ (etanercept).
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New advice to minimise risk
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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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Recent information relating to COVID-19 vaccines and medicines that has been published since the December 2022 issue of Drug Safety Update, up to 23 January 2022.
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False blood glucose readings when used to flush arterial lines leading to incorrect insulin administration and potentially fatal hypoglycaemia.
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New maximum daily dose restrictions (including in elderly patients), contraindications, and warnings.
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Patients should use the lowest effective dose, and the shortest duration of treatment necessary to control symptoms.
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Fingolimod can cause persistent bradycardia, which can increase the risk of serious cardiac arrhythmias. New contraindications have been introduced for patients with pre-existing cardiac disorders.
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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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A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 16 February 2021.
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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Prescribing advice should be followed carefully, particularly recommended upper dose limits due to associated higher gastrointestinal risk than most other NSAIDs in the class.
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Differences in dose delivery between the pump device and dropper device for memantine.
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Reports of acquired haemophilia have been received in association with clopidogrel.
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Letters were sent to healthcare professionals about Jext adrenaline autoinjectors, rivaroxaban, Ozurdex 700 micrograms intravitreal implant, sildenafil, hydrochlorothiazide, and Epilim Chronosphere (sodium valproate). We als…
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The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.
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Following observation in a clinical study of an increased risk of pulmonary embolism and overall mortality with tofacitinib 10 mg twice-daily in rheumatoid arthritis, a safety review has started and new contraindications int…
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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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Care needed when transferring from unlicensed formulations.
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The European Medicines Agency has advised that no change in recommendations for use is required at present.
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Warnings about the risk of severe and fatal burns are being extended to all paraffin-based emollients regardless of paraffin concentration. Data suggest there is also a risk for paraffin-free emollients. Advise patients who …