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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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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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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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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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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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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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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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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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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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Monitor patients for signs and symptoms of hypercalcaemia after discontinuation of denosumab treatment for giant cell tumour of bone. Cases of rebound hypercalcemia have been reported up to 9 months after cessation of treatm…
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A pooled analysis has shown an increased rate of new primary malignancies in patients given Xgeva (1-year cumulative incidence 1.1%) compared with those given zoledronic acid (0.6%), when used in the indication of the preven…
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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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Alerts were recently issued about RUSCH rectal/pharyngeal temperature sensors and Aquilon nebulisers.
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Mycophenolate mofetil and its active metabolite mycophenolic acid, both used to prevent transplant rejection, are teratogenic and genotoxic. The available clinical evidence does not indicate an increased risk of malformation…
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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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A European review has begun into the safety of radium-223 dichloride following an observed increase in the incidence of deaths and fractures in patients with chemotherapy-naive metastatic castration-resistant prostate cancer…
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Monitor patients closely for skin cancers. Advise patients to seek urgent attention if they develop signs or symptoms of serious infections.
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Letters were sent about eluxadoline (Truberzi), fingolimod (Gilenya), Bleo-Kyowa (bleomycin sulphate), Buccolam (midazolam), and ERWINASE.