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Outline of the safety experience of these medicines in the UK from our proactive safety monitoring strategy.
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Reports of reconstituted solution leaking from some models of extension sets and pumps.…
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Do not use in children aged 16 years or less, except in specialist settings under expert medical supervision.
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Use of a nebuliser purchased independently of medical advice for use in the home to deliver nebulised asthma rescue medications to children can mask a deterioration in the underlying disease and may increase the risk of pote…
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Systemic fluoroquinolones must now only be prescribed when other commonly recommended antibiotics are inappropriate. This follows a review by the MHRA which looked at the effectiveness of current measures to reduce the ident…
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Generic piperacillin/tazobactam products have different compatibilities with other medicines compared with tazocin, raising a risk of serious medication errors.
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It is essential that the entire contents of the solvent vial is added to the concentrate vial to produce a concentrate-solvent mixture with the intended concentration of 10 mg/mL cabazitaxel.
It is essential that the enti…
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…Since November 2014, letters were sent regarding vismodegib (Erivedge ▼), chlorhexidine solutions, carbocisteine oral liquid (Mucodyne Paediatric 125mg/5ml), regadenoson (Rapiscan), a parenteral nutrition emulsion (Triomel), and telavancin (Vibativ▼).…
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Advice for healthcare professionals on the reclassification of codeine linctus to a prescription-only medicine (POM), following a public consultation.
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Clinical trials have reported an increased risk of renal dysfunction and mortality in critically ill or septic patients who received hydroxyethyl starch (HES) compared with crystalloids.
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Updated guidance on minimising risk of life-threatening and fatal air embolism.
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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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Healthcare professionals prescribing fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin) are reminded to be alert to the risk of disabling and potentially long-lasting or irrevers…
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Modafinil potentially increases the risk of congenital malformations when used in pregnancy. Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment…
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Care must be taken with dosing as the 2 products are not equivalent.
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Pharmacists should tell people about the risk of fire when they discuss head lice eradication options.
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Before initiating systemic vascular endothelial growth factor (VEGF) pathway inhibitors, carefully consider the risk of aneurysm and artery dissection in patients with risk factors. In patients who receive a systemic VEGF pa…
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Fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients at risk for heart valve regurgitation (incompetence).
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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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…If symptoms or poor control of thyroid function persist (despite adhering to a specific product), consider prescribing levothyroxine in an oral solution formulation.
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Carefully consider the benefits and risks before prescribing systemic azithromycin or other systemic macrolide antibiotics (erythromycin or clarithromycin) to patients being treated with hydroxychloroquine or chloroquine. An…
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To be used only in patients with acute blood loss and when crystalloids alone are not sufficient.
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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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In March 2016, letters were sent regarding SGLT2 inhibitors, insulin lispro, natalizumab, noradrenaline, radium-223 dichloride, aflibercept and idelalisib.
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Last month, letters were sent regarding ketoprofen gel, fingolimod (Gilenya▼) and efavirenz (Sustiva).
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Emerade 300 and 500 microgram adrenaline auto-injectors have been re-supplied to the market following the implementation of corrective actions – patients and their caregivers should be provided with training and advice speci…
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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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Recall will begin in September 2011 to allow sufficient time for patients to be switched to suitable alternatives.
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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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We have launched a public consultation on the proposal to reclassify codeine linctus to a prescription-only medicine.
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Alerts were issued about T34 ambulatory syringe pumps, Gripper needles, and 1-day Acuvue Moist for astigmatism contact lenses.
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Tazocin (piperacillin/tazobactam) has been reformulated to meet European Pharmacopoeia requirements on particle size.
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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 information relating to COVID-19 vaccines and medicines that has been published since the November 2021 issue of Drug Safety Update, up to 3 December 2021.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and a recent National Patient Safety Alert asking organisations to put a plan in place to implement new regu…
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The growing number of oral tacrolimus products available on the market increases the potential for inadvertent switching between products, which has been associated with reports of toxicity and graft rejection. Therefore, to…
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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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Decreased vitamin B12 levels, or vitamin B12 deficiency, is now considered to be a common side effect in patients on metformin treatment, especially in those receiving a higher dose or longer treatment duration and in those …
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The paediatric indication for chloral hydrate (for children aged 2 years and older) and cloral (previously chloral) betaine (children aged 12 years and older) has been restricted to short-term treatment (maximum 2 weeks) of …
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If an adverse drug reaction is suspected, ask patients if they are taking any herbal or homeopathic medicines and report any suspicions to the Yellow Card scheme. Remind patients to check that a herbal or homeopathic medicin…
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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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We have introduced pack size restrictions, revised recommended ages for use, and new safety warnings for over-the-counter stimulant laxatives (orally and rectally administered) following a national safety review. Advise pati…
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Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of…
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We have initiated a new safety review into topiramate as a result of an observational study reporting an increased risk of neurodevelopmental disabilities in children whose mothers took topiramate during pregnancy.
Topir…