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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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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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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.
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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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An alert was recently issued by MHRA on JM103 and JM105 Jaundice Meters. We also remind you of an alert about Accu-Chek blood glucose test strips.
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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…
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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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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…
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An alert was issued about T34 ambulatory syringe pumps.
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Temporary safety measures are in place while an EU review investigates the link between cases of serious liver injury, including 4 cases requiring liver transplantation, and Esmya for uterine fibroids.
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Letters were sent about ellaOne, ERWINASE, Eperzan▼, Ocaliva▼, Velcade, Esmya, and Bleo-Kyowa.
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Monitor patients closely and remove the vaginal delivery system immediately in cases of excessive or prolonged uterine contractions, at the onset of labour, or if there is clinical concern for mother or baby.
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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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Alerts were recently issued about BD Alaris/Asena syringe pumps and Maxter Catheters nasogastric (NG) feeding tubes.
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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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Alerts were recently issued about Accu-Chek insulin pumps, Astral lung ventilators, and IntelliVue patient monitors used with 12-lead ECG.
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Letters were sent about INOmax (nitric oxide) cylinders and triptorelin (Decapeptyl).
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Alerts were issued about NovoPen Echo and NovoPen 5 insulin pens and BioMérieux antimicrobial susceptibility tests.
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Denosumab is associated with a risk of osteonecrosis of the jaw, osteonecrosis of the external auditory canal has also been reported with denosumab.
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Alerts were issued about LIFEPAK 1000 automatic external defibrillators, Mitroflow LX (sizes 19mm and 21mm) biological replacement pericardial aortic heart valves, and Accu-Chek Insight insulin pumps.
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We have received reports of depression and, in rare cases, suicidal thoughts in men taking finasteride 1 mg (Propecia) for male pattern hair loss. Be aware that depression is also associated with finasteride 5 mg (Proscar).
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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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Babies born to mothers who take valproate medicines (Epilim▼, Depakote▼) during pregnancy have a 30–40% risk of developmental disability and a 10% risk of birth defects. Despite communications to prescribers in January 2015 …
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Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes. Evidence does not show an increased risk for dapagliflozin and empagliflozin, but the risk may be a class effect. P…
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A summary of letters sent to relevant healthcare professionals in January 2017.
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A summary of recent safety letters sent to relevant healthcare professionals
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A summary of letters sent to healthcare professionals in September 2016, including important information for professionals who specialise in epilepsy treatment regarding the withdrawal from the market of retigabine (Trobalt).
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Medicines or herbal remedies that induce CYP3A4 enzymes reduce blood levels of levonorgestrel, which may reduce emergency contraceptive efficacy.
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A signal of increased lower limb amputation (primarily of the toe) in people taking canagliflozin compared with placebo in a clinical trial in high cardiovascular risk patients is currently under investigation.
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There have been rare reports of Nexplanon implants having reached the lung via the pulmonary artery. An implant that cannot be palpated at its insertion site in the arm should be located as soon as possible and removed at th…
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In May 2016, letters were sent regarding Nexplanon (etonogestrel implant) and ERWINASE.
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In April 2016, letters were sent regarding canagliflozin (Invokana▼, Vokanamet▼), BCR-ABL tyrosine kinase inhibitors, pomalidomide (Imnovid▼), and retigabine (Trobalt)
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Test for raised ketones in patients with ketoacidosis symptoms, even if plasma glucose levels are near-normal.
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In March 2016, letters were sent regarding SGLT2 inhibitors, insulin lispro, natalizumab, noradrenaline, radium-223 dichloride, aflibercept and idelalisib.
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In February 2016, a letter was sent to healthcare professionals regarding medicines containing valproate.
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Children exposed to valproate in utero are at high risk of developmental disorders and congenital malformations. Use the new communication materials below to discuss these risks with patients
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Levonorgestrel-releasing intrauterine systems should always be prescribed by brand name because products have different indications, durations of use, and introducers.
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Mycophenolate mofetil and its active metabolite mycophenolic acid are associated with a high rate of serious birth defects and increased risk of spontaneous abortion.
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Osteonecrosis of the external auditory canal has been reported very rarely (fewer than 1 in 10 000 patients) with bisphosphonates, mainly in association with long-term therapy (2 years or longer).
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In November, letters were sent regarding thalidomide, mycophenolate mofetil, nicorandil, InductOs, and dimethyl fumarate
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Mirabegron is now contraindicated in patients with severe uncontrolled hypertension; advice about regular monitoring is being introduced because of cases of severe hypertension.
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A letter was sent to healthcare professionals about mirabegron for symptomatic treatment of urgency, increased
micturition frequency, or urgency incontinence.
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Patient reminder cards about the risk of osteonecrosis of the jaw are being introduced; denosumab 120 mg is now contraindicated in patients with unhealed lesions from dental or oral surgery.
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Test for raised ketones in patients with acidosis symptoms, even if plasma glucose levels are near-normal.
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EU review confirms that the cardiovascular risk of high-dose ibuprofen (≥2400mg/day) is similar to COX 2 inhibitors and diclofenac.
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The most important risk factors for uterine perforation are insertion during lactation and insertion in the 36 weeks after giving birth. Before inserting an IUS or IUD, inform women of the risk and the symptoms of perforatio…