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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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New safety and educational materials have been introduced for men and women and healthcare professionals to reduce the harms from valproate, including the significant risk of serious harm to the baby if taken during pregnanc…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages.
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We are providing an update on a retrospective observational study on the risk to children born to men who took valproate in the 3 months before conception and on the need for the re-analysis of the data from this study befor…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices and a reminder of a recent MHRA National Patient Safety Alert to highlight the potential risk of underdosing …
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In view of data showing ongoing exposure to valproate in pregnancy, this article reminds healthcare professionals of the risks in pregnancy and the current Pregnancy Prevention Programme requirements, and provides informatio…
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A summary of recent letters and notifications sent to healthcare professionals about medicines, and a patient safety alert on mexiletine hydrochloride.
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
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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 recent medicine recalls and notifications 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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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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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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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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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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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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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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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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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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Maternal administration of magnesium sulfate for longer than 5–7 days in pregnancy has been associated with skeletal adverse effects and hypocalcaemia and hypermagnesemia in neonates. If use of magnesium sulfate in pregnancy…
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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…
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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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New guidance on contraceptive methods and frequency of pregnancy testing to reduce inadvertent exposures during pregnancy in a woman taking a medicine of teratogenic potential.
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Carbimazole is associated with an increased risk of congenital malformations, especially when administered in the first trimester of pregnancy and at high doses. Women of childbearing potential should use effective contracep…
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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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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…
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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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Reporting suspected adverse drug reactions to the Yellow Card Scheme helps to support the safe use of medicines in babies, children, and pregnant and breastfeeding women. Show your support for this year’s EU-wide ADR awarene…
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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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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…
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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…