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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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Addition of a polyethylene glycol (PEG)-based laxative to a liquid that has been thickened with a starch-based thickener may counteract the thickening action, placing patients with dysphagia at a greater risk of aspiration.
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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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Epimax Ointment and Epimax Paraffin-Free Ointment can harm the eyes if used on the face. Do not prescribe these ointments for use on the face. Tell patients to wash their hands and avoid touching their eyes after using these…
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Non-arteritic anterior ischemic optic neuropathy (NAION), a condition that can cause sudden deterioration in vision, usually in one eye at a time, has been very rarely reported in association with semaglutide in the treatmen…
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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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Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with these medicines. All patients should be tested for DPD deficiency be…
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Guidance has been published about thalidomide, lenalidomide, and pomalidomide and the use of remote consultations and home pregnancy testing for patients taking them during COVID-19.
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Use of Antipsychotic may be associated with an increased risk of venous thromboembolic events.
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There have been reports of severe, sometimes fatal, cases of cardiac failure in patients treated with crizotinib.
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A review is being undertaken by the Medicines and Healthcare products Regulatory Agency with advice from the Commission on Human Medicines and the Isotretinoin Expert Working Group due to concerns about the possible associat…
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We remind you to provide clear information to patients and caregivers regarding risk of accidental patch transfer and ingestion of patches, and need for appropriate disposal of patches.
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More than one treatment course is authorised only in women who are not eligible for surgery, and liver function monitoring is to be carried out in all women treated with Esmya. Before initiation, discuss with women the rare …
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Systematic reviews and meta-analyses of randomised controlled trials have highlighted a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors…
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We remind healthcare professionals that accidental use of glucose-containing solutions as flush fluid for arterial lines may contaminate blood samples and result in falsely high glucose readings. This may lead to inappropria…
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There have been a small number of reports of serious and life-threatening anticholinergic side effects associated with hyoscine hydrobromide patches, particularly when used outside the licence. Healthcare professionals, pati…
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Advice for healthcare professionals regarding the withdrawal of pholcodine-containing medicines from the market.
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Important to inquire if patients are taking herbal medicines.
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Updates have been made to the magnitude of the known risk of infantile hypertrophic pyloric stenosis following exposure to erythromycin in infancy as a result of new epidemiological data. The risk is particularly increased i…
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Advise patients treated with ingenol mebutate gel to be vigilant for new skin lesions and to seek medical advice immediately should any occur. Use with caution in patients with a history of skin cancer.
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A falsified version of Mounjaro (tirzepatide) KwikPen 15mg solution for injection has been found supplied through one online pharmacy in the UK. The falsified product is labelled with batch D873576 and applies to Mounjaro Kw…
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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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Cases of serotonin syndrome have been identified in associated with bupropion, especially in overdose or when bupropion is administered with other drugs with a serotonergic effect.
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In autoimmune conditions and some cancer therapies, methotrexate should be taken once a week; however, we continue to receive reports of inadvertent overdose due to more frequent dosing (including daily administration). New …
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Psychological side effects such as anxiety, low mood, sleep disturbance, poor concentration, and forgetfulness have been infrequently reported in people with cystic fibrosis treated with Kaftrio. Healthcare professionals sho…
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There is a risk of patient harm arising through medication error during a transition period where the original and new formulation of Rybelsus ® tablets, which have different stated mg doses but are bioequivalent, will both …
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We continue to receive a substantial number of serious and fatal adverse event reports for warfarin through our Yellow Card Scheme.
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Advise patients to tell their health professional if they experience severe eye irritation.
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Cases of iatrogenic botulism have been reported following the therapeutic or cosmetic use of botulinum toxin containing products where the toxin’s effect extends beyond the area of treatment. Patients should seek immediate m…
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Train patients to place the Braltus capsule in the correct chamber of the Zonda inhaler. We have received reports of patients who have inhaled a Braltus capsule from the mouthpiece into the back of the throat, resulting in c…
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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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…Please report adverse reactions to the Yellow Card scheme and promote vigilance among patients.
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Healthcare professionals should be aware of the potential for delayed onset of angioedema and the distinction between bradykinin- and histamine-mediated cases, as treatment strategies differ significantly and bradykinin-medi…
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We remind healthcare professionals that isotretinoin should only be used for severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. Prescription of isotretino…
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We have issued a National Patient Safety Alert following serious reports of harm associated with insulin leakage during use of the Accu-Chek Insight Insulin pump with NovoRapid PumpCart prefilled insulin cartridges. Patients…
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Erythromycin has been associated with events secondary to QT interval prolongation such as cardiac arrest and ventricular fibrillation. Erythromycin should not be given to patients with a history of QT interval prolongation…
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There have been very rare reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) with pseudoephedrine.
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Risk of meningioma with cyproterone acetate increases with increasing cumulative dose. Use of cyproterone is contraindicated in patients with previous or current meningioma (for all indications) and should only be considered…
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Measure serum immunoglobulin levels if recurrent infections develop. Consider bronchiectasis or pulmonary fibrosis if patients develop persistent respiratory symptoms.
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Globally, there has been a very small number of reports of new-onset or aggravation of pre-existing myasthenia gravis with atorvastatin, pravastatin, lovastatin, fluvastatin, simvastatin, rosuvastatin and pitavastatin (singl…
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Prescribers should be aware of the risk of potentiation of radiation toxicity with vemurafenib when given before, during, or after radiotherapy
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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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There is a risk of harmful drug interactions with the ritonavir component of the COVID-19 treatment Paxlovid▼ due to its inhibition of the enzyme CYP3A, which metabolises many commonly used drugs. Prescribers should obtain a…
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Healthcare professionals and patients are reminded of the risk of severe asthma attacks and increased mortality associated with overuse of SABA with or without anti-inflammatory maintenance therapy in patients with asthma. H…
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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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The Isotretinoin Expert Working Group of the Commission on Human Medicines has made recommendations to strengthen the safety of isotretinoin treatment. Recommendations include new warnings, the need for consistent monitoring…
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We have strengthened the safe use of isotretinoin through the introduction of additional oversight of the initiation of isotretinoin in patients under 18 years and through improved assessment and monitoring of mental health …
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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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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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Healthcare professionals should advise patients who need re-vaccination with Pneumovax II to expect a more intense reaction than after their first vaccination.