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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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Letters were sent about Insuman insulin products, mecasermin, and valproate medicines. Recalls were issued about ranitidine medicines and Paclitaxel.
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The Commission on Human Medicines has issued a series of recommendations to strengthen measures to minimise risk with the yellow fever vaccine (Stamaril) following very rare fatal reactions. Key recommendations include new a鈥�
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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鈥�
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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鈥�
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Advise patients that naltrexone/bupropion has been associated with adverse reactions such as dizziness or somnolence, which can affect ability to drive, operate machinery, or perform dangerous tasks. Advise patients not to d鈥�
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Letters were sent about Oncaspar鈻� (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鈥�
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Letters were sent about Myocrisin (sodium aurothiomalate), Cerliponase alfa (Brineura鈻�), Darzalex鈻�(daratumumab), retinoids鈻�, and febuxostat (Adenuric). A recall alert was issued for medicines that were taken out of the regul鈥�
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Letters were sent about tofacitinib (Xeljanz鈻�), Trisenox (arsenic trioxide), lapatinib (Tyverb), direct-acting oral anticoagulants, and Lartruvo鈻� (olaratumab). Alerts were issued about Epanutin (phenytoin) oral solution, Mac鈥�
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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鈥�
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Maternal administration of magnesium sulfate for longer than 5鈥�7 days in pregnancy has been associated with skeletal adverse effects and hypocalcaemia and hypermagnesemia in neonates. If use of magnesium sulfate in pregnancy鈥�
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Letters were sent about alemtuzumab (Lemtrada), Selenase (sodium selenite pentahydrate), and Erelzi鈻� (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鈥�
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Ongoing patient survey data suggest that more effort is needed by clinicians to achieve full and timely compliance with the valproate Pregnancy Prevention Programme and meet the goal to rapidly reduce and eventually eliminat鈥�
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As of 1 April 2019, pregabalin and gabapentin are controlled under the Misuse of Drugs Act 1971 as Class C substances and scheduled under the Misuse of Drugs Regulations 2001 as Schedule 3. Evaluate patients carefully for a 鈥�
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Letters were sent about Xeljanz鈻� (tofacitinib), ranitidine, Nulojix (belatacept), fluoroquinolone antibiotics, Genvoya鈻�, Stribild鈻�, Tybost, and belimumab (Benlysta鈻�). Drug alerts were issued about Accord losartan potassium c鈥�
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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鈥�
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Tapentadol may increase seizure risk in patients taking other medicines that lower seizure threshold, for example, antidepressants and antipsychotics. Serotonin syndrome has also been reported when tapentadol is used in comb鈥�
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Although use of valproate medicines in female patients continues to slowly decline, there is wide variation in prescribing between Clinical Commissioning Groups (CCGs). Women continue to report instances when they have not r鈥�
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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鈥�
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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鈥�
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Valproate medicines must not be used in women of childbearing potential unless the Pregnancy Prevention Programme is in place. If you are involved in the care of female patients on valproate in the UK, see a reminder of acti鈥�
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Monitoring for encephalitis should continue for 12 months following discontinuation of daclizumab. Inform all patients who have discontinued daclizumab and their caregivers of the common symptoms of encephalitis and the need鈥�
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Advise patients and their caregivers to seek urgent medical attention if any signs or symptoms of communicating hydrocephalus develop during nusinersen therapy for spinal muscular atrophy. Patients with communicating hydroce鈥�
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Letters were sent about daclizumab beta (Zinbryta鈻�), alteplase (Actilyse), Esmya (ulipristal acetate), and Xofigo鈻� (radium-223-dichloride). MHRA issued alerts and recalls for batches of Nutriflex Omega Special 2500 ml and Nu鈥�
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Letters were sent about valproate medicines, atezolizumab (Tecentriq鈻�), and nusinersen (Spinraza鈻�). MHRA issued alerts and recalls for valsartan-containing medicines, Fiasp FlexTouch pre-filled pens, melatonin capsules, and 鈥�
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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鈥�
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Use materials online now and hardcopies arriving over the coming weeks by post to ensure women and girls of childbearing potential on valproate medicines meet the requirements of the Pregnancy Prevention Programme.
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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鈥�
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Valproate medicines must no longer be used in women or girls of childbearing potential unless a Pregnancy Prevention Programme is in place. Ensure all women and girls (and their parent, caregiver, or responsible person, if n鈥�
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Letters were sent to healthcare professionals about Zinbryta鈻� (daclizumab beta), Lynparza 50 mg capsules, and radium-223-dichloride (Xofigo鈻�).
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The European Medicines Agency (EMA) has recommended the immediate suspension of the marketing authorisation and recall of daclizumab (Zinbryta) in the EU following reports of serious inflammatory brain disorders, including e鈥�
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Letters were sent about ellaOne, ERWINASE, Eperzan鈻�, Ocaliva鈻�, Velcade, Esmya, and Bleo-Kyowa.
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Omniscan and intravenous Magnevist are now no longer authorised for use and a product recall of any existing unexpired stock is underway.
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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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The use of daclizumab (daclizumab beta) is now restricted to adults with relapsing multiple sclerosis who have had an inadequate response to at least 2 other disease-modifying therapies (DMTs) and for whom other DMTs are con鈥�
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Letters were sent about cladribine (Litak and Leustat), radium-223-dichloride (Xofigo鈻�), and ERWINASE.
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A review has found that low levels of gadolinium can be retained in the brain and other tissues after administration of gadolinium-containing contrast agents (GdCAs). There is currently no evidence that gadolinium deposition鈥�
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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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Fingolimod can cause persistent bradycardia, which can increase the risk of serious cardiac arrhythmias. New contraindications have been introduced for patients with pre-existing cardiac disorders.
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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.
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Quinine has dose-dependent QT-interval-prolonging effects and should be used with caution in patients with risk factors for QT prolongation or in those with atrioventricular block.
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In addition to the 3 risk-based categories of antiepileptic drugs, patient-related factors should be considered when deciding whether it is necessary to maintain continuity of supply for a specific product.
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Gabapentin has been associated with a rare risk of severe respiratory depression even without concomitant opioid medicines. Patients with compromised respiratory function, respiratory or neurological disease, renal impairmen鈥�
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Letters were sent about ibrutinib, daclizumab, aflibercept, valproate medicines, and arsenic trioxide.
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While an urgent EU-wide review of new information on liver safety is under way, promptly review patients on treatment. Only initiate daclizumab in restricted groups of patients with limited treatment options and keep all pat鈥�
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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.