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…Fezolinetant should be avoided in patients with known liver disease or at a higher risk of liver disease.
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…Follow new guidance on testing liver function promptly in patients who report symptoms or have clinical signs that might indicate they have liver injury and adjust the dose or discontinue treatment according to new recommendations.…
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Routine monitoring of liver function now recommended.
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Cases of serious liver injury with elevated transaminases and bilirubin have been reported during treatment with Kaftrio–Kalydeco combination therapy.…
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The indication of ulipristal acetate 5mg for uterine fibroids has been further restricted due to the risk of serious liver injury and liver failure, with some cases requiring liver transplantation.…
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…Before initiation, discuss with women the rare risk of liver damage and advise them to seek urgent medical attention if they develop any symptoms or signs of liver injury.…
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Reminder to test liver function before and during treatment.
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…The licence for Esmya has been suspended to protect public health while a safety review is conducted following a further case of liver injury requiring transplant.…
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…Serious liver injury has been reported on treatment with tocilizumab from 2 weeks to more than 5 years after initiation.
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Liver monitoring requirements for cladribine in the treatment of multiple sclerosis have been introduced following uncommon cases of serious liver injury. Advise patients to seek urgent medical attention if they develop any clinical features of liver dysfunction.…
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liver-function testing recommended in patients with symptoms that may indicate liver injury.
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Liver function tests should be carried out at treatment initiation, during treatment, and also when the dose is increased.
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Temporary safety measures are in place while an EU review investigates the link between cases of serious liver injury, including 4 cases requiring liver transplantation, and Esmya for uterine fibroids.…
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While an urgent EU-wide review of new information on liver safety is under way, promptly review patients on treatment. Only initiate daclizumab in restricted groups of patients with limited treatment options and keep all patients under close liver function monitoring.
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…Discuss with patients the risk of hepatic injury and the liver monitoring requirements before starting or continuing daclizumab and ask them to sign an acknowledgement form to confirm they understand the information.
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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 viruses have also been reported during treatment.…
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Liver function should be tested before and during treatment with temozolomide.
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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.…
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Test liver function before and during treatment and tell patients to avoid sunlight exposure.
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Sitaxentan (Thelin▼) withdrawn due to hepatotoxicity.
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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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New monitoring instructions to detect these side effects as soon as possible.
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…Regular monitoring of cardiac, liver, and renal function during treatment is recommended
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Healthcare professionals prescribing nitrofurantoin should be alert to the risks of pulmonary and hepatic adverse drug reactions and advise patients to be vigilant for the signs and symptoms in need of further investigation.
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INR should be monitored closely during treatment of chronic hepatitis C with direct-acting antivirals in patients also receiving vitamin K antagonists (eg, warfarin), because of possible changes in liver function during treatment.…
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The European Medicines Agency (EMA) has recommended the immediate suspension of the marketing authorisation and recall of daclizumab (Zinbryta) in the EU following reports of serious inflammatory brain disorders, including e…
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A European review identified baseline markers as predictive factors for morbidity requiring hospitalisation and mortality in cirrhotic patients.
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Patients should be tested for hepatitis B virus before starting treatment with BCR-ABL tyrosine kinase inhibitors.
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Letters were sent about ellaOne, ERWINASE, Eperzan▼, Ocaliva▼, Velcade, Esmya, and Bleo-Kyowa.
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…High-risk gadolinium-containing contrast agents are contraindicated in patients with severe renal impairment, patients in the perioperative liver-transplantation period, and in neonates
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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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Patients should be assessed regularly due to reported cases of suicidal ideation and suicidal behaviour during treatment with duloxetine or shortly after stopping treatment.
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Use of aliskiren can cause angioedema, a rare and serious side effect, and or acute renal failure.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Amiodarone has been associated with serious and potentially life-threatening side effects, particularly of the lung, liver, and thyroid gland. We remind healthcare professionals that patients should be supervised and reviewed regularly during treatment.…
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New simplified guidance on treating paracetamol overdose with intravenous acetylcysteine including an updated treatment nomogram.
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Prescribers should be aware of the risk of potentiation of radiation toxicity with vemurafenib when given before, during, or after radiotherapy
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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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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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Intrahepatic cholestasis of pregnancy (ICP) has been rarely reported in patients treated with azathioprine products and is believed to be a risk applicable to all drugs in the thiopurine class (azathioprine, mercaptopurine a…
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Use in pelvic inflammatory disease only when other antibacterials are inappropriate or ineffective.
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Taking zolpidem is associated with a risk of impaired driving ability the next day.
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Risk of serious side effects on fertility, the liver, kidneys, immune system, blood, and heart.
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Letters were sent about ibrutinib, daclizumab, aflibercept, valproate medicines, and arsenic trioxide.
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Temporarily discontinue ibrutinib in patients who develop symptoms suggestive of ventricular arrhythmia and assess benefit-risk before restarting therapy. Establish hepatitis B virus status before initiating ibrutinib. Consi…
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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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Monitor glucose levels closely in patients with diabetes during direct-acting antiviral therapy for hepatitis C, particularly within the first 3 months of treatment, and modify diabetes medication or doses when necessary. Pa…
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Letters were sent about daclizumab beta (Zinbryta▼), alteplase (Actilyse), Esmya (ulipristal acetate), and Xofigo▼ (radium-223-dichloride). MHRA issued alerts and recalls for batches of Nutriflex Omega Special 2500 ml and Nu…
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Screening for hepatitis B virus is now recommended in all patients (not only those at risk of this infection) before starting treatment for all indications.