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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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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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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…
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Letters were sent about alemtuzumab (Lemtrada), Selenase (sodium selenite pentahydrate), and Erelzi▼ (etanercept).
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We have recently received 2 reports of fatal adverse reactions to the yellow fever vaccine (Stamaril). Due to an increased risk of life-threatening reactions, the vaccine must not be given to anyone with a medical history of…
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Pharmacokinetic data indicate exposure of elvitegravir boosted with cobicistat (Genvoya▼, Stribild) is lower during the second and third trimesters of pregnancy than postpartum. Low elvitegravir exposure may be associated wi…
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Letters were sent about Xeljanz▼ (tofacitinib), ranitidine, Nulojix (belatacept), fluoroquinolone antibiotics, Genvoya▼, Stribild▼, Tybost, and belimumab (Benlysta▼). Drug alerts were issued about Accord losartan potassium c…
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Alerts were issued about Pagewriter Cardiographs and Efficia Monitors and Fresenius 5008 & 5008S haemodialysis machines.
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Disabling, long-lasting or potentially irreversible adverse reactions affecting musculoskeletal and nervous systems have been reported very rarely with fluoroquinolone antibiotics. Fluoroquinolone treatment should be discont…
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Onivyde has been associated with reports of serious thromboembolic events, such as pulmonary embolism, venous thrombosis, and arterial thromboembolism.
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Letters were sent about Vyxeos (cytarabine, daunorubicin) and Ozurdex 700 micrograms intravitreal implant (dexamethasone). Alerts were issued about irbesartan, amoxicillin, atropine sulfate, and paracetamol infusion.
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Alerts issued include important actions for enFlow IV fluid and blood warmers due to a risk of unsafe levels of aluminium leaching from the device. Other alerts were issued on implantable cardiac pacemakers, Accu-Chek Insigh…
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If acute pancreatitis occurs during treatment with carbimazole, immediately and permanently stop treatment. Re-exposure to carbimazole may result in life-threatening acute pancreatitis with a decreased time to onset.
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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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Letters were sent to healthcare professionals about Lartruvo▼ (olaratumab), quadrivalent influenza vaccine (split virion, inactivated), SGLT2 inhibitors, and carbimazole and thiamazole (synonym: methimazole)-containing produ…
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Healthcare professionals should not prescribe them to newly diagnosed patients as first-line treatment, except for those with severe hypertriglyceridaemia or those who cannot take statins.
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Patients on ipilimumab who present with diarrhoea or other symptoms of colitis, and those who do not respond to steroid treatment for immune-related colitis, should be investigated to exclude other causes, including infectio…
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In December 2018, a letter was sent to notify healthcare professionals of the discontinuation of Zovirax (Aciclovir) eye ointment. We also highlight the recent recall of Actavis batches of irbesartan/hydrochlorothiazide tabl…
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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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A pharmacy-level recall of some valsartan-containing products took place due to possible contamination, including advice to healthcare professionals and information on supply. Letters were also sent about quadrivalent influe…
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Alerts were issued about ConvaTec Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags, CME T34 ambulatory syringe pumps, and HeartStart MRx monitor/defibrillators.
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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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In patients at risk for aortic aneurysm and dissection, fluoroquinolones should only be used after careful assessment of the benefits and risks and after consideration of other therapeutic options.
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Sildenafil is not authorised for use in pregnancy for the treatment of intrauterine growth restriction. The STRIDER clinical trial, which was studying the use of sildenafil in pregnancy for intrauterine growth restriction, h…
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Letters were sent to healthcare professionals about Jext adrenaline autoinjectors, rivaroxaban, Ozurdex 700 micrograms intravitreal implant, sildenafil, hydrochlorothiazide, and Epilim Chronosphere (sodium valproate). We als…
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An alert was recently issued by MHRA about CoaguChek Test Strips for Point of Care and Home Use due to a risk of false high results. Affected CoaguChek test strips may give false high results for INR values above 4.5 when co…
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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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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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Interrupt treatment if posterior reversible encephalopathy syndrome (PRES) is confirmed and resume treatment only once the event is resolved and the benefit of continued treatment outweighs the risk of PRES.
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Provide clear information to patients and caregivers about how to minimise the risk of accidental exposure and the importance of appropriate disposal of patches. We continue to receive reports of unintentional opioid toxicit…
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A supply disruption alert was issued by the Department of Health & Social Care (DHSC) on EpiPen and EpiPen Junior; see MHRA advice on extension of use beyond the expiry date for certain batches of EpiPen 300 microgram ad…
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Alerts were recently issued by MHRA about flex connectors in Halyard closed suction kits; SureSigns VS & VM patient monitors and viewing stations; and Zimmer Biomet trauma guide wires.
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Now only authorised for use in patients with symptomatic bone metastases and no known visceral metastases who have had 2 previous systemic treatments for metastatic castration-resistant prostate cancer or who cannot receive …
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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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More than one treatment course is authorised only in women who are not eligible for surgery, and liver function monitoring is to be carried out in all women treated with Esmya. Before initiation, discuss with women the rare …
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Letters were sent about valproate medicines, atezolizumab (Tecentriq▼), and nusinersen (Spinraza▼). MHRA issued alerts and recalls for valsartan-containing medicines, Fiasp FlexTouch pre-filled pens, melatonin capsules, and …
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Alerts were recently issued about Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines and Alaris and Asena enteral syringe pumps
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New pharmacokinetic data show mean exposure of darunavir (brand name Prezista) boosted with cobicistat (available in combination in Rezolsta▼, Symtuza▼) to be lower during the second and third trimesters of pregnancy than du…
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If bilirubin and/or creatinine test results are inconsistent with clinical observations, request re-testing using another method to determine the validity of the result.
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Following receipt of a third case of fatal medication error caused by the administration of Fungizone (a non-lipid-based formulation of amphotericin B) instead of a lipid-based formulation (AmBisome, Abelcet), we remind heal…
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Report to the Yellow Card Scheme suspected adverse reactions associated with medicines taken during pregnancy experienced by women or the baby or child. Obstetricians and midwives have a particularly important role in provid…
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Letters were sent about Cetrotide (cetrorelix acetate), Eperzan▼(albiglutide), darunavir/cobicistat, Keytruda▼ (pembrolizumab), Denzapine (clozapine) 50 mg/mL oral suspension, and Bleo-Kyowa (bleomycin sulphate).
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Alerts were recently issued by MHRA about Smiths Medical medication cassette reservoirs, Alaris Smartsite add-on bag access devices, and Combur10 Test UX and Chemstrip 10 A urinalysis test strips.
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New safety recommendations have been issued while an EU review evaluates cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir.