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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and start treatment urgently (including antibiotics and surgical debridement). Fournier’s gangrene is a rare but potentially life-threatening infection that requi…
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Recent information relating to COVID-19 vaccines and medicines that has been published since the November 2021 issue of Drug Safety Update, up to 3 December 2021.
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Test for raised ketones in patients with ketoacidosis symptoms, even if plasma glucose levels are near-normal.
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Use a filter needle when drawing up reconstituted dantrolene solution.
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A recent Europe-wide review of the safety information for alli has led to a number of updates, which bring the product information in line with that for Xenical.
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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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We remind healthcare professionals that accidental use of glucose-containing solutions as flush fluid for arterial lines may contaminate blood samples and result in falsely high glucose readings. This may lead to inappropria…
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A signal of increased lower limb amputation (primarily of the toe) in people taking canagliflozin compared with placebo in a clinical trial in high cardiovascular risk patients is currently under investigation.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Updated advice for healthcare professionals not to mix or infuse ceftriaxone with solutions containing calcium.
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Calcium salts (either calcium chloride or calcium gluconate) are used to stabilise the myocardium and prevent cardiac arrest in patients experiencing severe hyperkalaemia. However, the two salts are not equivalent in terms of calcium dose.…
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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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Letters were sent about Myocrisin (sodium aurothiomalate), Cerliponase alfa (Brineura▼), Darzalex▼(daratumumab), retinoids▼, and febuxostat (Adenuric). A recall alert was issued for medicines that were taken out of the regulated medicines supply chain during distribution.…
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
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Studies of cardiovascular risk don’t support prescribing changes.
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Monitoring of blood electrolytes is essential in patients coprescribed a potassium-sparing diuretic and an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) for heart failure.
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…Use of calcium gluconate injection packed in plastic containers is recommended to reduce aluminium burden in vulnerable patients
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Fatal cases of severe symptomatic hypocalcaemia, and risk of hypocalcaemia at any time during treatment.
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Diabetic ketoacidosis has been reported in patients with type 2 diabetes on a combination of a GLP-1 receptor agonist and insulin who had doses of concomitant insulin rapidly reduced or discontinued. GLP-1 receptor agonists …
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Prescribers should be alert for neuropsychiatric reactions in patients taking montelukast and carefully consider the benefits and risks of continuing treatment if they occur.
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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 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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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages. The article also includ…
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Recent epidemiological evidence of an increased risk of fracture with long-term use of proton pump inhibitors (PPIs).
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices and details of two recent MHRA National Patient Safety Alerts to remove from service Philips Health Systems V…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages.
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In January 2020, healthcare professionals received updated educational materials to support the valproate pregnancy prevention programme. Valproate is contraindicated in girls and women of childbearing potential, unless the …
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Minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia.
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Review by two specialists remains in place for patients initiating valproate under 55 years of age but the Commission on Human Medicines (CHM) has advised that it will not be required for men (or males) currently taking valp…
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We are providing an update on a retrospective observational study on the risk to children born to men who took valproate in the 3 months before conception and on the need for the re-analysis of the data from this study befor…
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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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In view of data showing ongoing exposure to valproate in pregnancy, this article reminds healthcare professionals of the risks in pregnancy and the current Pregnancy Prevention Programme requirements, and provides informatio…
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A retrospective observational study has indicated a possible association between valproate use by men around the time of conception and an increased risk of neurodevelopmental disorders in their children.
Inform male p…
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New recommendations following a recent clinical trial which found that in patients with type 1 hepatorenal syndrome terlipressin may cause serious or fatal respiratory failure at a frequency higher than previously known, and…
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Monitor patients for signs and symptoms of hypercalcaemia after discontinuation of denosumab treatment for giant cell tumour of bone. Cases of rebound hypercalcemia have been reported up to 9 months after cessation of treatm…
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Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of…
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…If use of magnesium sulfate in pregnancy is prolonged or repeated, consider monitoring of neonates for abnormal calcium and magnesium levels and skeletal adverse effects.…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices and a reminder of a recent MHRA National Patient Safety Alert to highlight the potential risk of underdosing with calcium gluconate in severe hyperkalaemia.…
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Although use of valproate medicines in female patients continues to slowly decline, there is wide variation in prescribing between Clinical Commissioning Groups (CCGs). Women continue to report instances when they have not r…
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Emerging clinical trial evidence of increased cardiovascular risk.
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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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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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Updated advice on use of nicorandil as second-line treatment for stable angina - some ulcers may progress to complications unless treatment is stopped.
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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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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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A summary of letters and drug alerts recently sent to healthcare professionals.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Advise patients taking hydrochlorothiazide-containing products of the cumulative, dose-dependent risk of non-melanoma skin cancer, particularly in long-term use, and the need to regularly check for (and report) any suspiciou…
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The maximum recommended dose for simvastatin in conjunction with amlodipine and diltiazem is now 20 mg/day.