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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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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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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 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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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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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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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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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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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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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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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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Letters were sent about azithromycin, Lynparza▼(Olaparib), Xgeva▼ (denosumab), Lymphoseek (tilmanocept), ReoPro (abciximab) and dolutegravir; you still have time to complete a quick survey to tell us your views on the way me…
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Letters were sent about insulin Fiasp and Tresiba and Inhixa (enoxaparin sodium); use survey to feedback your thoughts on Direct Healthcare Professional Communications (DHPCs) and on the way medicines safety issues are commu…
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An alert was issued recently about Accu-Chek Aviva, Accu-Chek Performa, and Accu-Chek Inform II test strips – risk of strip error messages and false high and low blood glucose results. An alert was also issued recently about…
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Letters were sent to healthcare professionals about Zinbryta▼ (daclizumab beta), Lynparza 50 mg capsules, and radium-223-dichloride (Xofigo▼).
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An alert was issued about T34 ambulatory syringe pumps.
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Letters were sent about ellaOne, ERWINASE, Eperzan▼, Ocaliva▼, Velcade, Esmya, and Bleo-Kyowa.
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Letters were sent about Buccolam (midazolam), misoprostol vaginal delivery system (Mysodelle), noradrenaline, Relenza (zanamivir), mycophenolate mofetil/mycophenolic acid, Flolan, and Fludara.
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Recombinant human erythropoietin (r-HuEPO) treatment has been associated with very rare cases of life-threatening severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necro…
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Letters were sent about cladribine (Litak and Leustat), radium-223-dichloride (Xofigo▼), and ERWINASE.
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Alerts were recently issued about BD Alaris/Asena syringe pumps and Maxter Catheters nasogastric (NG) feeding tubes.
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Consider progressive multifocal encephalopathy (PML) in the differential diagnosis for patients with new or worsening neurological signs or symptoms, even several years after treatment with cladribine.
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Letters were sent about eluxadoline (Truberzi), fingolimod (Gilenya), Bleo-Kyowa (bleomycin sulphate), Buccolam (midazolam), and ERWINASE.
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Letters were sent in September about Dacogen (decitabine), Eperzan▼(albiglutide), ERWINASE, ReoPro (abciximab), and recombinant human erythropoietins.
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Patients taking warfarin should not use over-the-counter miconazole oral gel (Daktarin). If you plan to prescribe miconazole oral gel in a patient on warfarin, you should closely monitor them and advise that if they experien…
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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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Letters were sent about ibrutinib, daclizumab, aflibercept, valproate medicines, and arsenic trioxide.
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Recent clinical trials have shown increased mortality when bendamustine (Levact) was used in combination treatments outside its approved indications. Be aware that the risk of opportunistic infections for all patients receiv…
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There have been reports of rejection of solid organ transplants in patients treated with nivolumab or pembrolizumab. Ipilimumab (Yervoy▼) may also interfere with immunosuppressive therapy, increasing the risk of graft reject…
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Letters were sent about Arsenic Trioxide (Trisenox), Uptravi▼ (selexipag), DepoCyte (cytarabine), Cinryze▼ (C1 esterase inhibitor [human]), and Clexane (enoxaparin sodium).
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Letters were sent about Pharmalgen (Bee Venom and Wasp Venom) Initial kits, bendamustine (Levact), and ERWINASE.
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A summary of letters sent to healthcare professionals, including an important reminder about the withdrawal of retigabine (Trobalt) from the market.
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Prescribers should consider reducing the dose of ponatinib to 15 mg a day for patients with chronic phase chronic myeloid leukaemia (CP-CML) who have achieved a major cytogenetic response.
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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 trea…
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A summary of recent safety letters sent to relevant healthcare professionals
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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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Before starting treatment with pomalidomide, establish hepatitis B virus status in all patients.
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There are new interim treatment recommendations for idelalisib for chronic lymphocytic leukaemia and follicular lymphoma in light of new findings from clinical trials outside its currently authorised drug combinations or ind…
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Use a lower starting dose of thalidomide in patients with untreated multiple myeloma who are older than age 75 years.
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In November, letters were sent regarding thalidomide, mycophenolate mofetil, nicorandil, InductOs, and dimethyl fumarate
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There have been reports of thrombotic microangiopathy and nephrotic syndrome linked to interferon beta treatment.
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Patients with active infection with this virus should not be treated with ofatumumab.
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Capillary leak syndrome (CLS) has been reported in recipients of filgrastim, including patients undergoing chemotherapy and a healthy donor undergoing peripheral blood progenitor-cell mobilisation; it has also been reported …
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Contraindications clarified and reminder to monitor renal function.
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Healthcare professionals should consider the possibility of second primary malignancy in patients treated with lenalidomide.