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A summary of letters and drug alerts recently sent to healthcare professionals.
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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. Although the temporary sus…
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Pregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised respiratory function, respiratory …
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Information on the newly launched Safer Medicines in Pregnancy and Breastfeeding Consortium and a new report on optimising data on medicines used during pregnancy.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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New recommendations following a review of the risks of dependence and addiction associated with prolonged use of opioid medicines (opioids) for non-cancer pain. Before prescribing opioids, discuss with the patient the risks …
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Following a review of the risks associated with use of opioid medicines for non-cancer pain, the Commission on Human Medicines (CHM) has recommended that fentanyl transdermal patches are contraindicated in opioid-naive patie…
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In autoimmune conditions and some cancer therapies, methotrexate should be taken once a week; however, we continue to receive reports of inadvertent overdose due to more frequent dosing (including daily administration). New …
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Evaluate a patient’s individual factors for benefits and risks before initiating treatment with denosumab 60mg, particularly in those with previous vertebral fracture. Patients should not stop denosumab without specialist re…
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Use baricitinib with caution in patients with diverticular disease and in those concomitantly treated with medications associated with an increased risk of diverticulitis.
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A summary of letters and drug alerts recently sent to healthcare professionals, including recommendations to reduce handling errors with leuprorelin-containing depot medicines.
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A summary of Medical Device Alerts recently issued by the MHRA.
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Remain vigilant for signs and symptoms of bleeding complications during treatment with DOACs (apixaban, dabigatran, edoxaban, rivaroxaban), especially in patients with increased bleeding risks. Specific reversal agents are a…
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Guidance has been published to support initiation of valproate in female patients and for annual review and pregnancy testing during the coronavirus pandemic.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Contact patients currently taking Esmya for uterine fibroids as soon as possible and advise them to stop their treatment. The licence for Esmya has been suspended to protect public health while a safety review is conducted f…
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Caution should be used in patients with known risk factors for venous thromboembolism in addition to the underlying disease. Patients older than 65 years of age are at an increased risk of serious infections and should be tr…
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Discontinue baricitinib treatment permanently if clinical features of deep vein thrombosis or pulmonary embolism occur. Prescribers are reminded to use caution if using baricitinib in patients with risk factors for deep vein…
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Benzodiazepines and opioids can both cause respiratory depression, which can be fatal if not recognised in time. Only prescribe together if there is no alternative and closely monitor patients for signs of respiratory depres…
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Letters were sent on Typhim Vi vaccines, Mepact (mifamurtide), and Xeljanz (tofacitinib) and an alert issued to recall Emerade 150 microgram adrenaline pens.
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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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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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Amended advice on the insertion site for Nexplanon contraceptive implants following concerns regarding reports of neurovascular injury and implants migrating to the vasculature (including the pulmonary artery).
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Letters were sent about methotrexate, modafinil, Ecalta, Picato, Nexplanon, valproate medicines, e-cigarettes, and Lemtrada. Alerts were issued about finasteride, codeine/paracetamol, and Picato.
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Alerts were issued about Convex two-piece skin barriers for use with ostomy bags and HeartStart XL+ defibrillators. A notice was also issued following reports of falsely depressed creatinine results for patients on phenindio…
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Recent epidemiological studies suggest exposure to ondansetron during the first trimester of pregnancy is associated with a small increased risk of the baby having a cleft lip and/or cleft palate.
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Letters were sent about Insuman insulin products, mecasermin, and valproate medicines. Recalls were issued about ranitidine medicines and Paclitaxel.
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Letters were sent about ranibizumab and Emerade adrenaline auto-injectors. Alerts were issued about ranitidine, paracetamol, omeprazole, mitomycin-C Kyowa, folic acid, and Emerade adrenaline auto-injectors.
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Domperidone is no longer licensed for use in children younger than 12 years or those weighing less than 35 kg. Results from a placebo-controlled study in children younger than 12 years with acute gastroenteritis did not show…
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Letters were sent about quadrivalent influenza vaccine, fentanyl ampoules, and Volibris (ambrisentan), and a number of pharmacy-level recalls were issued for ranitidine-containing products. Other alerts issued in October 201…
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Alerts were issued about Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and kits, Philips Efficia professional-use defibrillators/monitors, and CME T-34 3rd edition syringe driver pumps. A notice was also is…
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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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Fingolimod is associated with an increased risk of major congenital malformations including cardiac, renal, and musculoskeletal defects, when used in pregnancy. Women of childbearing potential must use effective contraceptio…
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New data have confirmed that the risk of breast cancer is increased during use of all types of HRT, except vaginal estrogens, and have also shown that an excess risk of breast cancer persists for longer after stopping HRT th…
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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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Letters were sent about Oncaspar▼ (pegaspargase), Ketalar (ketamine) injection, and Elmiron (pentosan polysulfate sodium). A recall was issued for several medicines taken out of the regulated medicines supply chain, includin…
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Alerts were issued about Telefunken automated external defibrillators and BD Microtainer capillary blood specimen collection tubes.
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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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Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be measured before starting treatment with tocilizumab and monitored every 4–8 weeks for the first 6 months of treatment followed by every 12 …
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MHRA has received a small number of reports suggesting lack of efficacy (thromboembolic events) in patients taking 15 mg or 20 mg rivaroxaban on an empty stomach; remind patients to take 15 mg or 20 mg rivaroxaban tablets wi…
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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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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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New prescriber checklists, patient reminder cards, and pharmacy checklists are available to support the Pregnancy Prevention Programme in women taking acitretin, alitretinoin, and isotretinoin. Advice about the risk of neuro…
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Letters were sent about tofacitinib (Xeljanz▼), Trisenox (arsenic trioxide), lapatinib (Tyverb), direct-acting oral anticoagulants, and Lartruvo▼ (olaratumab). Alerts were issued about Epanutin (phenytoin) oral solution, Mac…
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Alerts were issued about paclitaxel drug coated balloons (DCBs) and implantable drug-eluting stents (DESs) in the treatment of patients with peripheral artery disease, and Aisys and Aisys CS2 anaesthesia devices.
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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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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…