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…Drug alerts were issued about Accord losartan potassium containing products and Ozurdex implants.…
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Tazocin (piperacillin/tazobactam) has been reformulated to meet European Pharmacopoeia requirements on particle size.
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All products to be named and prescribed as caffeine citrate.
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Care must be taken with dosing as the 2 products are not equivalent.
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A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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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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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 o…
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Fatal cases of tumour lysis syndrome (TLS) have been reported, some occurring in patients with chronic lymphocytic leukaemia receiving the lowest venetoclax dose used in the dose-titration schedule. For all patients, it is i…
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The maximum adult daily dose of hydroxyzine is now 100 mg. Do not prescribe hydroxyzine to people with a prolonged QT interval or risk factors for QT interval prolongation.
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New warnings due to risk of hyperkalaemia, hypotension, and impaired renal function have been agreed following an EU-wide review.
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Use has been restricted to 48 hours’ maximum parenteral use under specialist supervision, after a European safety review.
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There is a risk of rhabdomyolysis if Systemic fusidic acid (Fucidin) is given with statins.
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Clinical trial results suggest an increased risk of atrial fibrillation for zoledronic acid (Aclasta▼), pamidronic acid, and possibly for alendronic acid, although the balance-risk remains favourable for bisphosphonates.
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…Renal function monitoring is recommended after use of zoledronic acid in at-risk patients—especially those with pre-existing renal impairment.…
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…The use of gadobenic acid (also known as gadobenate dimeglumine; MultiHance) and gadoxetic acid (Primovist) will be limited to delayed phase liver imaging only*.…
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…Other alerts were issued about paracetamol tablets, docetaxel injection, Baxter potassium-chloride-containing intravenous infusions, and Emerade adrenaline auto-injectors.…
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A clinically significant interaction between carbapenems and valproic acid results in reduced valproate plasma concentrations with potential for inadequate seizure control.…
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Omniscan and intravenous Magnevist are now no longer authorised for use and a product recall of any existing unexpired stock is underway.
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We are aware of reports of serious liver injuries and deaths in patients with primary biliary cholangitis with pre-existing moderate or severe liver impairment who were not adequately dose-adjusted. Follow dose reduction and…
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Systematic reviews and meta-analyses of randomised controlled trials have highlighted a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors treated with omega-3-acid ethyl ester medicines compared to placebo…
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…Cholestasis of pregnancy associated with thiopurines tends to occur earlier in pregnancy than non drug-induced cholestasis of pregnancy, and elevated bile acid levels may not reduce with ursodeoxycholic acid.…
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Following a review of the available toxicological data and a calculation of daily exposure to boron from a typical dosing regimen, we have concluded that the balance between the benefits and risks of chloramphenicol eye drops containing borax or boric acid remains positive for children…
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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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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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Gadolinium-containing contrast agents are associated with a varying degree of risk of nephrogenic systemic fibrosis. See advice below to minimise risk in the following vulnerable groups: patients with renal impairment; patie…
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Patient reminder cards about the risk of osteonecrosis of the jaw are being introduced; denosumab 120 mg is now contraindicated in patients with unhealed lesions from dental or oral surgery.
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Rivaroxaban treatment in patients who undergo transcatheter aortic valve replacement (TAVR) should be stopped and switched to standard of care.
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Mycophenolate mofetil and its active metabolite mycophenolic acid, both used to prevent transplant rejection, are teratogenic and genotoxic.…
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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 prevention of skeletal-related events with advanced malignancies involving…
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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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Check full blood counts before prescribing dimethyl fumarate and then every 6 to 12 months. Stop treatment immediately if you suspect progressive multifocal leukoencephalopathy.
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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, medicine recalls and notifications sent to healthcare professionals.
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MHRA continues to identify cases of herbal medicines, particularly traditional Chinese medicines, which contain illegal and toxic Aristolochia or aristolochic acids.
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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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A clinical trial has shown an increased risk of recurrent thrombotic events associated with rivaroxaban compared with warfarin, in patients with antiphospholipid syndrome and a history of thrombosis. Other direct-acting oral…
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There have been reports of cardiac events including QT prolongation, torsades de pointes, and cardiac arrest in patients who have taken high or very high doses of loperamide as a drug of abuse or for self-treatment of opioid…
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A summary of letters and drug alerts recently sent to healthcare professionals.
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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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Measure serum immunoglobulin levels if recurrent infections develop. Consider bronchiectasis or pulmonary fibrosis if patients develop persistent respiratory symptoms.
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There is no known interaction between oseltamivir and aspirin but aspirin must not be given to anyone younger than 16 year.
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Letters were issued about parenteral nutrition products, ranibizumab, ingenol mebutate gel, adrenaline auto-injectors, and fingolimod. Recall alerts were recently issued about ranitidine, aripiprazole, and bisacodyl.
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Letters were sent about ellaOne, ERWINASE, Eperzan▼, Ocaliva▼, Velcade, Esmya, and Bleo-Kyowa.
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Atypical femoral fractures reported rarely with bisphosphonate therapy, mainly in patients receiving long-term treatment for osteoporosis.
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N-acetylcysteine may interfere with assays from Siemens ADVIA Chemistry and Dimension/Dimension Vista instruments, leading to false-low biochemistry test results.
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Overall benefits of long-acting β-agonists (LABAs) in the treatment of chronic obstructive pulmonary disease (COPD) continue to outweigh any risks.
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Updated contraindications and maximum dose recommendations when taken with a number of other medicines.
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A summary of recent letters and notifications sent to healthcare professionals about medicines
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Cases of progressive multifocal leukoencephalopathy have been reported in patients taking dimethyl fumarate for multiple sclerosis, who all had prolonged lymphopenia.