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There is a potential risk of fatal overdose due to confusion between lipid-based and non-lipid-based formulations of parenteral amphotericin B.…
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Reporting suspected adverse drug reactions to the Yellow Card Scheme helps to support the safe use of medicines in babies, children, and pregnant and breastfeeding women. Show your support for this year’s EU-wide ADR awarene…
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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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There have been reports of worsening nasal congestion (rebound congestion) when the effects of nasal decongestant sprays or drops containing xylometazoline hydrochloride and oxymetazoline hydrochloride, wear off.
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Idiopathic intracranial hypertension (IIH) has been very rarely reported in patients treated with mesalazine. Following a recent review, warnings for IIH are being added to the product information for all mesalazine products…
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…There are case reports in the literature describing cobalt sensitivity-type reactions in patients being treated for vitamin B12 deficiency.…
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In April 2016, letters were sent regarding canagliflozin (Invokana▼, Vokanamet▼), BCR-ABL tyrosine kinase inhibitors, pomalidomide (Imnovid▼), and retigabine (Trobalt)
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Letters were sent about ibrutinib, daclizumab, aflibercept, valproate medicines, and arsenic trioxide.
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…Alerts were issued about ranitidine, paracetamol, omeprazole, mitomycin-C Kyowa, folic acid, and Emerade adrenaline auto-injectors.…
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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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We have strengthened the safe use of isotretinoin through the introduction of additional oversight of the initiation of isotretinoin in patients under 18 years and through improved assessment and monitoring of mental health …
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The ANNOUNCE study failed to show clinical efficacy for olaratumab in its current indication of advanced soft tissue sarcoma and the benefit risk balance is therefore now considered negative. No new patients should be starte…
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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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How to reduce risk of illicit use.
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Calciphylaxis is a very rare but serious condition causing vascular calcification and skin necrosis.
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From October 2014 Dexamethasone 4 mg/ml injection (Organon Laboratories Limited) will be replaced by Dexamethasone 3.8 mg/ml solution for injection (Aspen Pharma Trading Limited).
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Avoid concomitant use of amiodarone with simeprevir (Olysio▼) and sofosbuvir (Sovaldi▼) combination therapy, unless other antiarrhythmics cannot be given.
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Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias should not be treated with riociguat in light of interim results from a recently terminated study.
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Mixing drugs together, where one is not a vehicle for the administration of the other, creates an unlicensed medicine.
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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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Avoid concomitant use of amiodarone with ledipasvir-sofosbuvir (Harvoni▼), and amiodarone with sofosbuvir (Sovaldi▼) and daclatasvir (Daklinza▼), unless other antiarrhythmics cannot be given.
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Test for raised ketones in patients with acidosis symptoms, even if plasma glucose levels are near-normal.
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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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Some batches of gentamicin sulphate active pharmaceutical ingredient (API) used to manufacture gentamicin may contain higher than expected levels of histamine, which is a residual from the manufacturing process. Monitor pati…
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A letter was sent to advise healthcare professionals about a restriction to the indication and route of administration for Mitomycin-C Kyowa 40 mg following the observation of increased sub-visible particles in the drug product on storage.…
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There have been reports of acute pancreatitis associated with drugs in the dipeptidylpeptidase-4 (DPP-4) inhibitor class of antidiabetic agents (‘gliptins’).
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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 regul…
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The Commission on Human Medicines (CHM) has endorsed changes to isotretinoin prescribing guidance. In addition, CHM is seeking further information from dermatology services who prescribe isotretinoin to inform any future cha…
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Antiepileptic treatment is associated with a small risk of suicidal thoughts and behaviour.
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Studies of cardiovascular risk don’t support prescribing changes.
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The MHRA has reviewed the warnings regarding addiction, dependence, withdrawal, and
tolerance for gabapentin, pregabalin, benzodiazepines, and z-drugs. The findings (detailed in the Public Assessment Report) were that it wa…
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There is an increased risk of myopathy associated with high-dose (80 mg) simvastatin. The 80-mg dose should be considered only in patients with severe hypercholesterolaemia and high risk of cardiovascular complications who h…
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Aluminium can be leached from glass after contact with calcium gluconate solution, leading to a risk of exposure to aluminium. Accumulation of aluminium might have adverse effects on bone mineralisation and neurological deve…
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Co-proxamol's phased withdrawal period lasts until the end of 2007 to enable patients to move to suitable alternatives.
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In 2008 MHRA commissioned Ipsos MORI to research the public’s perception of herbal medicines, the findings may help doctors and pharmacists when considering how to advise patients.
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Stavudine should only be used when there are no appropriate alternatives, and for the shortest possible time.
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In light of feedback, we have clarified our article on concomitant use of these medicines in heart failure.
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Monitor thyroid-stimulating hormone (TSH) in patients treated with levothyroxine for at least the first month after starting and ending ritonavir treatment.
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If pioglitazone is used in combination with insulin patients should be observed for signs and symptoms of heart failure, weight gain, and oedema.
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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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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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Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes. Evidence does not show an increased risk for dapagliflozin and empagliflozin, but the risk may be a class effect.…
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Patients should be advised to promptly report to their doctor any changes in their breast tissue such as lumps, pain, or nipple discharge.
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Avoid use in patients with previous or existing psychiatric symptoms and discontinue treatment if new or worsening psychiatric symptoms occur.
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There have been reports of necrotising and haemorrhagic pancreatitis in people taking exenatide some of which were fatal - stop exenatide treatment if pancreatitis is diagnosed.
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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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Long-acting β2 agonists (LABA) should only be prescribed in conjunction with inhaled corticosteroids for the treatment of moderate to severe asthma.
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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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Cases of serotonin syndrome have been identified in associated with bupropion, especially in overdose or when bupropion is administered with other drugs with a serotonergic effect.
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Should not be used for cough under 18 years